VasQ External Support FDA Fast-tracked as New Fistula Success Option
The VasQ, a nitinol (nickel titanium) cage placed around a new artery and vein boosts the chances that a fistula will develop successfully. The FDA has granted breakthrough device designation to Laminate Medical’s new tool.
VasQ External Support FDA Fast-tracked as New Fistula Success Option
The VasQ, a nitinol (nickel titanium) cage placed around a new artery and vein boosts the chances that a fistula will develop successfully. The FDA has granted breakthrough device designation to Laminate Medical’s new tool.
NextKidney May Be the Next Home HD Option
Dutch companies Debiotech and NeoKidney have created Nextkidney SA to lead development and commercialization of the Neokidney—a lightweight, plug-and-play, home HD machine that fits in a suitcase and weights less than 22lbs.
One Step Closer to an Implantable Kidney
Dr. Fissell’s breakthrough—a “bioreactor” that contains working kidney cells—is helping to make an implantable artificial kidney possible
New Device in Testing May SAVE Failed Fistulas
Balloon angioplasty has been to open narrowing fistulas, but the narrowing often recurs. Now, a first patient has been enrolled in the MedAlliance SAVE study, using a balloon coated with sustained-release sirolimus to apply the drug to the inside of a fistula. This approach has been effective in the heart and other blood vessels.
Removing B2m with Nanobodies
Among those on dialysis, a build up in the blood of Beta-2 microglobulin (B2m) is responsible for potentially crippling dialysis-related amyloidosis (DRA). Nanobodies are functional antibody fragments—and, used in a resin, they captured 17 times more B2m than in earlier studies, without affecting other blood proteins. Even better, the resin can be regenerated and used again. One day, this approach may be combined with dialysis to improve treatments.
Shrinking a Qidni
Morteza Ahmadi, CEO of Quidni labs, aims to design a small blood purification device that will offer longer treatment times and ultimately replace dialysis in clinics—at 40% less cost. With grants from programs including the Canadian Space Agency, the vision of Qidni is to “surpass current technology to become the new standard of treatment and help millions of patients on dialysis live a normal life.”
Wearable Fist Assist Device Enlarges Veins for Hemodialysis
A battery-operated, wearable device applies gentle intermittent compression to increase vein size before—and after—fistula creation, for more successful hemodialysis access. Fist Assist, which is sold in India and has CE Mark approval in Europe, is a creative way to help patients improve their own fistula outcomes. Read
A PD Catheter that Detects Peritonitis Early
The future may be here soon. San Francisco-based startup CloudCath just received $12M to develop a real-time monitoring device that will measure PD fluid, detect infection, and notify the care team.
A Cure for What Ails Kidneys?
What if dialysis was not needed at all? An Israeli study demonstrating in mice that damaged kidney cells can be rejuvenated and replaced is now heading to clinical trials. The KidneyCure Bio firm aims to reverse chronic kidney disease using the patient’s own cells. If it works, dialysis might no longer be necessary.
Start-ups Around the Globe Focus on Portable PD
Singapore-based AWAK Technologies is one of several start-ups worldwide—including Triomed (Sweden), Wearable Artificial Organs (US) and Dutch start-up Nanodialys (Netherlands)—that are seeking ways to shrink PD machines to 2-3 Kilos, using 250 ml or less of fluid.
BioIntelliSense BioSticker is FDA-approved
A new on-body sensor sticker will allow 30 days of continuous monitoring of vital signs, sleep status, activity levels—and even body position—for home settings, including dialysis. Fresenius has invested in this technology that aims to allow clinicians to be proactive by health problems or falls sooner, which may reduce the need for ER visits and hospital stays.
AWAK PD Attracts Funding
Singapore-based Awak PD won FDA breakthrough device designation after completing its first-in-human study in October 2018, with no serious adverse events, and has now raised $40M in a financing round to support late-stage clinical studies and commercialization of its portable, wearable, sorbent-based PD device.
PD to Go, Please
A month-long trial of 100 PD sessions in 15 patients using an Automated Wearable Artificial Kidney (AWAK) found no serious adverse events. The AWAK would allow PD on-the-go, overcoming the challenge of long hours of therapy and the need to connect to large dialysis machines.
Portable, Wearable Dialysis—from Russia With Love
A 3.5 kilo (7.7 lb.) backpack dialysis device is being developed by Russian scientists. A smartphone will start and stop treatment, and send alerts; 3 liters of water will be regenerated into dialysate. Tested on pigs, the Russian artificial kidney is predicted to reach the market in about 3 years.
Tablo is Almost Home
Outset Medical released a study that the Tablo met both safety and efficacy endpoints for home. Currently FDA-cleared for use in hospitals and clinics, the new system is under evaluation by FDA for home dialysis use.
PeritoneX - Johns Hopkins Student Project to Reduce Peritonitis in PD
Relavo, a company started by a Johns Hopkins engineering student, has designed a way to reduce the risk of infection with PD. The PD tubing ends connect to the PeritoneX device, which automatically disinfects them. When done, the device should be palm-sized. The Relavo team expects to finish development in the next 6-12 months, and then start testing.
Progress on an Implantable Artificial Kidney Reported at ASN
The Kidney Project, led by Shuvo Roy, PhD and nephrologist William H. Fissell, MD, is developing a two-part, deck-of-cards sized implantable bioartificial kidney to replace dialysis. A hemofilter will remove toxins. A bioreactor containing human kidney cells will control fluid volume and blood pressure, adjust salts, and make hormones. At ASN Kidney Week 2019, the project announced that a prototype bioreactor was successfully placed in large animals with no immune reaction or blood clots—and no immunosuppression needed. The system now awaits FDA approval to do a clinical safety trial.
Diality is Moving Forward with Portable Home HD
Irvine, CA-based Diality received a $10 million Series A investment round to develop its portable home HD machine. The company is focusing on creating a less burdensome way to dialyze, for a better quality of life.
Fresenius-licensed Endexo Smart Polymer Gets FDA Breakthrough Status to Prevent Clots
nterface Biologics Inc. (IBI) from Canada has developed Endexo as a way to help make dialyzer membranes and bloodlines more biocompatible—and less likely to clot. The technology, for which Fresenius holds an exclusive world-wide license, will reduce the need for heparin and other blood thinners.
No Stick Access!
Full-time access use is a sticking point (pun intended) for an artificial kidney. “Veins don’t like having plastic tubes in them,” noted Steven Ash, MD, FACP in a talk. CEO of HemoCleans Technologies LLC and Ash Access Technologies, Dr. Ash has worked on a needle-free access port for nearly 40 years. The STARgraft AV hemodialysis access graft, which causes less trauma than a catheter, has been in clinical trials since April.
Fast Track AWAK
Based on successful human trials in Japan, a WAK wearable PD system using sorbent technology received FDA fast track status this year. With thrice-daily use, the device removed toxins and had no serious adverse events. And, since dialysate is regenerated, dramatically less fluid volume can be used.
Animal Testing Set to Begin for UCLA-U of A Implantable Artificial Kidney
Researchers on the UCLA-University of Arkansas team plan to test a new, filtration and electron deionization-based implantable kidney on pigs. Now suitcase-sized, the aim is to shrink the device to fit into a backpack.
VA and Google Deepmind Collaborate on AI to Detect AKI
Early treatment of acute kidney injury can be more successful and save kidneys. Using VA data, researchers at Google Deepmind developed an artificial intelligence model to detect AKI up to 48 hours before it would otherwise be identified.
When Pigs Fly—or are Transplanted
Since 2004, a Korean research center has been developing gnotobiotic miniature pigs and clinical platforms for xenotransplantation of pancreatic islets and cornea into humans. The group plans to use gene-editing to remove swine viruses, and anticipates starting human trials late this year.
Portable Nuclear Magnetic Resonance Scanner Could “See” Body Water
Removing enough—but not too much—water is key to the success of dialysis. A new way to measure fluid buildup under development by MIT researchers could make dialysis safer.
Quanta Takes a Step Toward FDA Approval for the SC+ Home HD Machine
In a press release issued last week, Quanta—which recently raised $48M in a funding round—announced a partnership with Design Science to begin human factors testing of the SC+ with a diverse range of adult dialyzors in preparation for an FDA 510(k) application later this year.
New AAKHI to Create Incentives for Innovations—Like Artificial Kidneys!
Growing a New Human Kidney
A free downloadable journal article describes three reasons to generate new human kidneys and reveals progress in efforts to do so.
Kidney X Award Pipeline Includes Home Dialysis Innovations
On April 29, Kidney X awarded 15 prizes of $75,000 each to innovations in kidney care. Each winner can compete for a larger prize. Some, like Outset Medical and Curion Research Corporation are working on home and wearable HD. Stanford researchers are working on real-time analysis of PD fluid to find infection early.
Johns Hopkins Undergrads Invent Device to Reduce Peritonitis Risk
A team of biomedical engineering students have won prizes for their invention. They started a company called Relavo to develop PeritoneX. The affordable, disposable device disinfects contamination points before a PD exchange begins.
Simergent is Reinventing the PD Cycler
Founded in 2014, the small Chicago start-up is using $2.8M in venture capital to develop a cheaper, simpler PD cycler with a color touchscreen, silent operation, and a device to help prevent peritonitis.
KidneyX Phase 1 Receives 165 Funding Applications
The KidneyX partnership between HHS and the American Society of Nephrology asked for ways to replace kidney function and boost quality of life. Up to 15 Phase 1 awards of $75,000 for the best prototypes are expected, followed three $500,000 Phase 2 awards.
Can Stem Cells Replace Kidney Transplants?
Researchers at Wake Forest are using stem cells from amniotic fluid as a universal cell source to regrow tissues. Injecting the stem cells into a diseased kidney improved function after 10 weeks—and repaired some blood vessel damage.
Overlook Medical Center Rides a Wavelinq for Non-Surgical Dialysis Access
The WavelinQ device uses radiofrequency waves and magnets to form a dialysis fistula without surgery. The cutting-edge Overlook Medical Center in New Jersey is pioneering use of the brand-new, FDA-approved option.
Made-To-Order Human Kidneys?
Japanese scientists are injecting animal blastocysts with stem cells to grow functional organs. Thus far, they have grown new pancreases—and mice kidneys—in rats. The approach may one day prove useful for new human kidneys.
Ontario’s Qidni Labs is a New Player in Kidney Innovation
Qidni Labs, an Ontario start-up, has TWO big kidney dreams: a portable dialysis machine AND an implantable kidney grown on a scaffolding of real kidney cells. If they can find money to test their ideas, they hope to be on the market in 4-5 years.
Catch the Easy Access Wave
A vascular surgeon in Louisiana was the second in the U.S. to use the WavelinQ endovascular system to create a dialysis fistula—without surgery.
AWAK PD Device Receives FDA Breakthrough Device Status
The AWAK Technologies PD device will be wearable and ultra-portable, using sorbent technology.
Downsizing Dialysis with New Membrane Materials
Mxene, a new sorbent material just a few atoms thick, can be fine-tuned to remove urea (NOTE: and other wastes that matter more?) from the blood. It shows promise for a wearable artificial kidney.
How Your Stomach May One Day Help Your Kidneys
Israeli researchers are using stomach cells to grow stem cells AND personalized “hydrogel” that can be grown into new organs with no risk of rejection. They are focusing on spinal cord injury and heart damage now, but plan to move into other organs as well. Perhaps, kidneys?
Dean Kamen Has $80M from the DOD and an ARMI to Grow Human Organs
Inventor Dean Kamen—best known in the dialysis industry because his company, DEKA, bought the rights to the Aksys PHD home HD machine—has a new venture. He won a Department of Defense contract to start the Advanced Regenerative Manufacturing Institute (ARMI). The aim: to scale up and commercialize efforts to grow human organs, including kidneys. Read the story.
$2.625M in Prize Money to Improve Treatment Options for Kidney Failure
The U.S. Department of Health and Human Services and American Society of Nephrology have pledged $2,625,000 in prize money for disruptive innovation in kidney failure treatment. Phase 1, with up to 15 prizes of $75,000 each, will launch later this month. Phase 2, in 2019, will award up to three $500,000 prizes for best prototypes.
Outset Gets One Step Closer
$132 million in venture funding brings Outset Medical a step closer to bringing the Tablo home for HD. Read the story.
Quanta Nears UK Launch
Quanta’s personal hemodialysis system, SC+, designed to give patients flexibility and empower them to take control of their dialysis, will present at the UK Annual Dialysis Conference September 20-21 in Manchester—and plans a UK launch in 2019. Read the story.
FDA Approves First Surgery-Free HD Access System
The Wavelinq AVF System by Becton Dickson, which lets vascular surgeons create a HD fistula using magnets, was recently approved by the FDA. Use of the device may cause less inflammation and more successful accesses. Read the story.
KidneyX Funding Legislation Proposed in WA State
KidneyX is a public-private partnership to speed innovation to prevent, diagnose, and treat kidney disease. ASN has committed $25 million to KidneyX for year 1 and a matching $25 million/year for years 2 – 5—and Rep. DelBene (WA) is sponsoring legislation to generate the matching $25 million for each of the next 5 years.
FDA Okays TWO New Systems to Create HD Fistulas!
The FDA recently approved two catheter-based systems for easier creation of arteriovenous fistulas in patients needing hemodialysis: The Ellipsys Vascular Access System, by Avenu Medical, and the everlinQ endoAVF system by TVA (now purchased by BD).
A WAK-y Dream Coming True?
This NKF article says there are just two more human trials to go before the WAK (wearable artificial kidney) might be ready for the public. The latest WAK version has a smaller battery that can be charged at night, and with fewer parts, weighs just two pounds.
Early Warning System for Peritonitis
The UK-based Microbiosensor company completed a successful pilot of the PD Safe device, which tests used PD fluid to catch infections much earlier than symptoms alone can do. Reagent chemicals detect bacteria, change color, and alert the PD patient.
Improving HD Outcomes? Theranova, Baby!
Baxter’s new dialyzer can clear more large and middle molecules than standard hemodialyzers—and about the same as hemodiafiltration, but without the need for replacement fluid. Importantly, this was done without affecting anemia or bone minerals.
H-Guard Guards Hearts
The UK has made a £500 investment in Invizius' H-Guard—a product that aims to reduce the risk of heart disease by coating dialyzer fibers with an anti-inflamatory “primer” to make them more biocompatible.
Fly Qanta to France!
Quanta completed its first 2-week pilot trials of its SC+ home hemodialysis machine outside the UK with five patients in France—where it performed well and was easy to use. The company is continuing to expand its reach, and plans for a commercial launch later this year.
Grow it Yourself Fistula
Aditlys wants to help people build their own, more reliable dialysis access—by implanting a hollow, polymer-based artificial implant. The implant will serve to be a structure for new tissue that will grow around it—and will then dissolve
With help from a free, online kidney atlas built by researchers at USC, scientists have used stem cells to build mini-kidneys—and even successfully transplanted one into a living mouse. The tiny kidneys will be used to test drugs and create new options for kidney replacement therapy.
What if instead of standard solutions, we could tailor dialysate to meet the needs of each individual? A new microfluid sensor that can monitor blood electrolytes during dialysis treatments may one day be able to reduce symptoms.
Bring Home the Bacon
Genetically-engineered pigs are back. Is it safe to use their kidneys to help address the shortage of human organs for transplant?
The V-Wing Didn’t Make It; Perhaps the AV-Guardian Will?
The implantable Advent Access av-Guardian device will guide cannulation to reduce infiltrations and pain from HD treatments.
A PD Solution to Protect Peritoneal Membranes
PD-protec® by Zytoprotec, which now has FDA orphan drug status, is in Phase III trials among 300 patients in the US and Europe. The product aims to reduce PD complications such as peritonitis and membrane failure.
Print a Kidney
Bioprinting and gluing together ink droplets holds strong promise for regenerative medicine.
Surgery-free Dialysis Fistulas on the Horizon
Ultrasound-guided nanotechnology (Ellipsys Vascular Access System, from Avenu Medical) has been used to fuse arteries and veins to create dialysis fistulas without surgery! The 23-minute procedure worked 95% of the time in an early trial, with 90% good enough to do dialysis, less time to first cannulation—and lower infection risk and scarring.
Baxter Theranova: More Middle Molecules, Less Albumin Loss
Baxter’s new dialyzer mimics the function of natural kidneys more closely, removing more middle molecules with no replacement fluid needed—and minimal loss of vital albumin. The new expanded hemodialysis (HDx) therapy has been tested in the UK, where it reduced beta-2 microglobulin levels by more than 11%
Morteza Ahmadi is seeking another $2.5M in investments to continue development of Qidni wearable nano-filters for continuous blood cleaning. Testing in pigs and sheep has gone well; the palm-sized device connects to a central venous catheter. The start-up won $550K in a New York state innovation competition. Read the story.
Qanta Will Soon Enter its Portable SC+ into the UK HHD Arena
Portable home HD? Check! Overnight treatments? Check! A successful home HD pilot with more than 1,100 treatments in UK patients brings the Quanta SC+ one step closer to an expected launch date of 2018 in the UK. Next step: The US? Read the story.
Gel to Promote Dialysis Fistula Success
What if a surgeon could help AV fistulas mature, just by applying a gel? Researchers at the University of Alabama at Birmingham have developed a bionanomatrix gel that could boost fistula success and even reduce the risk of later stenosis. The gel mimics the endothelial lining of blood vessels, and a $2M grant will help the researchers continue their vital work.
Obstacle Overcome to 3D Printed Kidneys
How do you 3D print the tiny, complex blood vessels in the kidneys? Prellis Biologics has found a way to print microvasculature—and has obtained $1.8M in seed funding to take the approach to the next step.
A New Way to Remove More Toxins
German researchers have developed a way to use alternating current to break the link between toxins and protein and remove more toxins during an HD treatment. And, an international investor just paid 7 figures for it. Next up: Clinical trials.
When Pigs Fly…
…Or perhaps sooner, as scientists study how to gene-alter pig organs to avoid tissue rejection or infection when the organs are used for transplant. But, ethical questions remain.
Home Dialyzors United Helps Guide the Kidney Project
UCSF and Vanderbilt researchers are collaborating on an implantable kidney that would be powered by patients’ own hearts—and HDU is helping to give them patient perspectives on the research.
VasQ and A
The FDA has approved VasQ, a new device to reduce fistula failure, for a 2-year clinical trial with 129 patients. The device keeps fistulas from growing too large by providing an external support.
Can someone build a solar dialysis machine for less than US$1000 at scale, will do treatments for less than $5 a day with any water source, and be as good as current machines? The George Institute and Mr. Garvey are banking on it!
The University of Virginia dialysis clinic started a transitional care unit for people starting dialysis, giving them a chance to learn about dialysis and how to care for themselves in a controlled environment, and improving the chance that they will choose a home treatment.
Promising New PD Fluid
In a Phase 2 study, PD-protec® from Zytoprotec in Vienna, Austria, reduced the risk of peritonitis and of membrane failure. The new fluid was well-tolerated, with no adverse events. Once on the market, this fluid could improve PD outcomes and allow more people to stay longer on the therapy.
New Membrane Material Tested
MIT has made a working dialysis membrane out of graphine. One layer of carbon atoms about the size of a fingernail filtered nanometer-sized molecules out of water based fluids up to ten times faster than standard membranes. With more pores, the graphene may filter as much as 100 times faster.
Tablo Announces $76.5M Investment.
*Bringing its total to $185.5M, Outset Medical announces a new investment from T. Row Price Associates. The Tablo machine is rethinking HD technology from the ground up. A minifridge-sized unit can purify tap water, send and receive data, and even clear air bubbles from the dialyzer and bloodlines.
AWAK Attracts Investment Billions
Singapore-based AWAK Technologies’ miniaturized sorbent platform for PD and HD regenerates dialysate to use up to 90% less fluid. This package was intriguing enough to attract an $11.2B investment from Accuron MedTech—improving its changes of reaching the market!
EasyDial Breaks Ground for Dharma Portable HD Machine Manufacturing
A 42,000 square foot manufacturing site in Indiana will create up to 100 new jobs for Hoosiers by 2020—building the Dharma portable HD machine, which looks to be about the size of an airplane carry-on bag. The Dharma has not yet been FDA-approved.
On-demand PD in the Works
Imagine PD without space-eating boxes full of heavy, fluid-filled bags! Baxter has received FDA guidance on technology for the Amia cycler to produce on-demand sterile PD fluid using an integrated water filtration device. Patient testing is slated to begin in 2018.
When Pigs Fly
Biologist Luhan Yang’s research on lifesaving organs growing inside droves of pampered swine strives to create “designer pigs” whose organs can be transplanted into people to ease the organ shortage.
Outset Medical is looking to expand its Tablo label to include home use by sponsoring a 40-patient investigational device exemption (IDE) trial for the all-in-one dialysis device.
PD on the Move
Baxter is seeking FDA approval for sterile PD solution on-demand in the home. This greener approach would reduce truck deliveries, and require much less supply storage space in the home. The first clinical trial is expected to start next year!
Northwest Kidney Centers Invests in the Future of Dialysis
NKC will provide a $15 million grant over the next 5 years to support the University of Washington’s Center for Dialysis Innovation to transform dialysis. The aim is to develop low-cost, energy and water-efficient therapies, including wearable dialysis.
Coming Soon to a Clinic Near You?
Quanta’s SC+ HD machine, approved in Europe, is easy-to-use, compact, and integrates fluid management into a disposable cartridge. This design will simplifies HD treatments and improves infection control.
Fistula Vessel Sleeve Aims to Optimize Blood Flow and Reduce Surgery
Laminate has designed a device for aimed to help arteriovenous fistulas last longer: the VasQ sleeve is an external support device. It fits over the vein and anastomosis and helps lower the tension in the artery, for optimal blood flow during dialysis.
Innovative “FireFly” PD Catheter Connection May Reduce Peritonitis
PuraCath uses low-cost technology—a unique UV light based connection system—to reduce bacterial and fungal contamination during PD exchanges, without the need for chemical disinfectants.
Copycat Device Mimics Kidney Function
A new device uses human cells to replicate kidney function, so it can better predict the body's response to drugs than animals or static cell cultures.
Change, It is a’Coming
The Vanderbilt/UCSF implantable artificial kidney, a far different model than the wearable kidney, is making progress toward human trials, even as soon as late 2017/early 2018. Developed by Dr. William Fissel and bioengineer Shuvo Roy, PhD, the project has a $5M NIH grant and uses a biohybrid approach that better mimics healthy kidney function.
If You Build it They Will Come
Accuron Technologies has invested 11.2 million to commercialize AWAK’s sorbent platform, which aims to reduce the cost and complexity of dialysis while making it smaller and more portable.
Dialysis with Living Cells
Dialysis removes some water and wastes, but can’t do other functions of healthy kidneys, like making hormones, that require living cells. Now, researchers at the University of Michigan have a way to grow, preserve, and store living kidney cells for use in a dialysis system. See the new bioartificial renal epithelial cell system (BRECS) here!
Button, Button, Who’s Got the Buttonhole?
Advent Access in Singapore has developed the titanium av–Guardian implant to guide needle placement so more people will be able to self-cannulate.
The WAK Prototype is Looking Different
Check out this article and video about a another clinical trial of the "wearable" kidney taking place in San Antonio, TX to see the new look.
Coming Soon to a Home Near You…
The Tablo automated dialysis machine, now FDA approved, is designed for patients to use by themselves, with a simple step-by-step procedure that makes it easy to operate.
Bluegrass Vascular Technologies has a new vein access device, approved in Europe, that can regain access to obstructed veins.
Plastic Dialysis Cannulas!
Now used in Japan and Australia—but not the US—use of plastic cannulas vs. metal needles for HD may reduce the risk of vessel wall damage or infiltration. While the plastic cannulas cost more, following further study, they could benefit restless patients, children, patients on long HD sessions or those with metal allergies.
Keeping the Pipes Clean.
A study in Singapore suggests a way to prevent breakdown of blood cells during dialysis. Researchers treated dialysis tubing with a water-repellent coating to decrease contact between blood and the tubing surface—reducing hemolysis in animal blood.
Home HD Reimagined
Unlike Baxter, Outset Medical CEO Leslie Trigg thinks people will want to consider home HD, so they developed the Tablo, a sleek new user friendly machine with an app-like touchscreen interface, with the goal of eventually entering the expanding home HD market.
Will a New PD Fluid Prevent Fibrosis?
PD-protec®, by Zytoprotec, is a PD dialysate designed to reduce or avoid peritoneal damage, so more patients can stay on PD longer, with better outcomes. The product is being tested in Austria, with results expected at the end of this year.
How to Get Better Middle Molecule Clearance
Baxter’s THERANOVA dialyzer, approved in Europe, had significantly higher overall toxin clearance than current high-flux dialysers, according to eight abstracts presented at this year’s ERA-EDTA meeting.
US Next in Line for Minimally Invasive Fistula Creation System
Avenu’s Ellypsys Vascular Acess System uses a catheter guided through a blood vessel to create a dialysis fistula by fusing vessels together with heat. There is no foreign material (even stitches). CE-MARK approved in Europe, and a Phase III trial in the U.S. is underway.
Anyone Got a Tissue?
A novel bioengineered vein comprised of human tissue (HAV) implanted into the arms of patients for HD access had positive results—which opens the door for future developments.
Affordable Dialysis Prize Yields Game-changing New Design.
A working dialysis machine that runs on solar, purifies water from any source—and costs less than 900€? That was the challenge met by inventor Vincent Garvey. His new “small, portable and potentially revolutionary” HD machine won him a $91,000€ prize.
U.S. Home Dialysis is About to Heat Up…
Baxter has begun U.S. human trials for its VIVIA home HD machine. The VIVIA will offer high dose daily HD and nocturnal HD, and features integrated water treatment and web-based remote connectivity.
3D Printed Tissue Takes a Step Forward
3D printing is exciting, but the Achilles heel has been getting a blood supply to the printed tissue. Scientists have now found several ways to address this challenge, which can help the technology move ahead.
Implantable Artificial Kidney Will Offer Freedom
The National Institutes of Health are giving a multi-million dollar grant to UCSF’s Dr. Shuvo Roy and his team, to help move an implantable artificial kidney toward human testing, aiming for 2 years from now. Many are excited about the potential for this kidney to free people from dialysis.
Microchip Biohybrid Kidney is on the Near Horizon
Dr. William Fissel and his team at Vanderbilt are developing a synthetic kidney packed with microchip filters and living kidney cells—powered by a patient’s own heart. The current challenge is to prevent blood from clotting in the device. With the help of 3D printed prototypes, they are working toward human trials at the end of next year
ExThera’s new Seraph filter is being tested to prevent sepsis during HD. Now in clinical trials, the Seraph can bind and remove disease-causing agents from blood. Future trials will look at using the filter to treat sepsis.
New Balloon Inflates Hopes for Access Stenosis
The IN.PACT Admiral DEB by Medtronics fights re-stenosis in HD fistulas and grafts. The CE-Mark approved balloon opens the vessel—and delivers a dose of paclitaxel to the vessel wall, to keep extra cells from growing.
Fistulas Without Surgery
In Canada and Australia, TVA Medical’s test of creating fistulas by sending radiofrequency waves through catheters has worked. Of the 60 study patients, 98% had a fistula, and 91% were still working 3 months later.
Home Dialysis Technology Shown at the ASN
Learn about the home equipment that was previewed at last November’s ASN meeting in San Diego, from Fresenius sorbent technology to bagless PD from NxStage, Baxter’s Amia cycler, the Outset Tablo home HD machine and much more.
New Anemia Pill In The Works
Akebia and Fibrogen are both vying to treat chronic kidney disease patients—including dialyzors who suffer from anemia—with a pill. If approved, the drugs will take aim at replacing less convenient, injectable anemia drugs like Amgen's Epogen.
Wearable Kidney May Be The Next Best Thing To Transplant!
Although years away, a small trial of 7 patients showed the artificial kidney to be promising. Participants were able to eat and drink as they chose, with no limits. All said they would switch to the WAK if it were commercially available. Read the article.
Grow Your Own Kidney One Day
Scientists at the University of VA have found human stem cells that grow into kidney blood vessels. And, as the blood vessels form, they also create blood cells. Doctors did not previously know that blood cells are also formed within the kidneys.
One Step Closer to Kidney Cloning
Cloning could transform transplant medicine by turning a few skin cells into perfectly-matched organs. Advanced Cell Technologies, from MA, claims to have already succeeded creating a trial embryo clone. Read the article.
Everlinq Reports Successful New Approach to Vascular Access
The everlinQTM System forms an HD access with radiofrequency energy at sites not traditionally used by surgeons. The system has CE Mark approval, but is not yet available in the U.S.
Human HD WAK Trials Reported at ASN
The FDA requires “proof of concept” trials, and Dr. Victor Gura’s 10-lb. HD wearable artificial kidney has passed its first one. Seven patients wore the WAK for 24 hours, with no adverse events and consistent ultrafiltration rates. Malfunctions such as tubing leaks, CO2 bubbles in the dialysate, and variable blood and dialysate flow rates stopped the trial, and the WAK, fast-tracked by the FDA, will be redesigned before it is tested again.
Implantable Artificial Kidney Development Receives $6M NIH Grant
Wow! Vanderbilt University Medical Center (Wiliam Fissell IV, MD is the co-PI) and the University of California at San Francisco (bioengineer Shuvo Roy, PhD is the co-PI) have teamed up to develop an implantable artificial kidney. The project, in the works for more than a decade, has been fast-tracked by the FDA, and will use silicon nanotechnology and cell culture.
Newcomer Quanta Treats First Home HD Patients with SC+!
Easy-to-use, portable, flexible…the Quanta SC+ is small, light, quiet, and now a step closer to market with a successful pilot test under its belt. Six UK men and women with a wide range of body weights completed a total of 40 treatments with no adverse events—and rated the machine highly. The SC+ has CE Mark approval in Europe.
NxStage Offers Next Generation Home HD and PD Teasers
In Q4 of 2016, NxStage plans to release an updated home HD cycler that makes dialysate faster and has a touch screen display. And, a bagless PD system that will reduce the need for PD supply storage and the number of connections is expected at the end of 2017.
Fresenius + Debiotech = Micro PD!
The Swiss are well known for their precision miniature devices like watches, and now a new partnership between dialysis giant Fresenius and award-winning Swiss manufacturer Debiotech promises to yield exciting new solutions for compact, lightweight, and even more portable PD, with a focus on boosting ease of use.
Surgery-free Stent Graft May Make Dialysis Access Easier
UK researchers are working on a new way to achieve dialysis access. The ePATH stent graft would be placed through a needle to create a channel after aligning the vein and artery, with no surgery needed.
Teen-built $500 Portable HD Machine Could Be a Game Changer
At 17, Anya Pogharian’s volunteer stint in a dialysis clinic inspired her to design a portable HD machine for home use. Now 19, she has been testing the prototype, and it is getting closer to market.
Wake Forest recycles “waste” kidneys into tailor-made replacements
Can the 2,600 donated kidneys each year that must be discarded be repaired and used? That’s the goal of Wake Forest researchers, who want to replace the kidneys’ stem cells with an individual’s, so anti-rejection medications would not be needed. The group has, thus far, proven that washing away donor cells does not damage the function.
$91M in development capital for a home HD machine
It’s big news that Outset Medical (formerly Home Dialysis Plus) has attracted funding to get their Tablo machine into production, into clinics, and ultimately into homes! The easy to use machine is just under three feet tall, and will make its own dialysate.
eQOL eases home dialysis burdens for consumers
A Canadian company has developed an “enhanced quality of life” (eQOL) tablet tool that will help home dialyzers document their treatments (including photos the team can react to), order and track supplies, connect with their care teams, and learn about kidney disease.
Geroneph wants to build behind-the-ear dialysis connectors!
PlugMed, which creates ways to transfer fluid through the skin with less risk of infection, has won a 2 million Euro World Innovation Challenge to speed development of Geroneph—an “osseointegrated” dialysis connector to transfer PD or HD dialysate through the skin behind the ear. Stay tuned!
Wearable artificial kidney trial in 10 people
See a video with pictures of the WAK and a brief interview with inventor Dr. Victor Gura.
New dialyzor manufacturing approach cuts cost by 70%
Costly spinnerets to make hollow fibers for dialyzers in the correct sizes are not available in India, which must import dialyzers from other countries. A new approach using disposable syringe assemblies cuts costs and won a runner up prize in the fifth National Award for Technology. In vitro tests have been done, and the next steps are animal and then human testing.
Portable dialysis “jacket bag” for low-cost treatments
Dr. Puneet Gupta, from Raipur, India, has been working on a portable, lower cost approach to hemodialysis since 2012. The new device will use 1 liter of water, and a battery that weighs less than 1 kilo.
Preventing PD infections with ultraviolet (UV) light
San Francisco-based PuraCath Medical has developed a novel PD connection system that uses UV light to kill a wide array of bacteria and fungi. Clinical trials with patients will begin soon.
New system will form fistulas with no surgery
TVA Medical, from Austin, TX, has a new system that creates dialysis fistulas by inserting one catheter into an artery and one into a vein, linking them with magnets, then using a burst of radiofrequency energy to create a fistula. The pipeline product, called everlinQ, is being studied in Canada, Australia, and New Zealand, and early results look very promising.
More WAK facts
“When we tell a patient that dialysis will be necessary, the human reaction to hearing those words is, uniformly, devastation,” said Dr. Victor Gura, inventor of the wearable artificial kidney (WAK).
Michigan company trials PD support via iPad
eQOL in Sault Ste. Marie, MI, has partnered with the Sault Area Hospital (SAH) to try out an iPad-based telemedicine platform to support people who do PD. “It's like having their healthcare team in their own living room with them, they can ask questions, communicate with us, the software sends us information without us having to call and bother the patient, it identifies if there's a concern so we can be very proactive in dealing with a problem before we need to admit the patient to hospital," said Dr. Berry of SAH.
This machine could be a home dialysis game changer
A Canadian teen has invented a simplified machine for home HD for a high school science fair, and instead of $30K, it costs about $500. While she intends the machine for developing countries, who knows?
Have a cappuccino with Dr. Claudio Ronco and discover WAK-man!
Dr. Ronco’s group in Vicenza, Italy is working on a wearable vest for continuous ultrafiltration (water removal from the blood). See a prototype and hear his description.
Baxter shows new PD and home HD machines at the ADC
At the Annual Dialysis Conference in New Orleans, Baxter showed its new Amia PD cycler, which is 10 lbs. lighter and has a touch pad, and its Vivia home HD machine, available in Europe but not yet in the US.
Which Pipeline Machine Company has Morphed into Outset Medical?
Europe gets a new home HD machine!
Maybe the new Quanta will come to the US next. The portable home HD and in-center machine is designed for flexibility, and has a single-use cartridge.
A UK hospital is testing a video link to support home dialysis patients
What happens if you have a question DURING a home treatment? If you dialyze through the Lancashire Teaching Hospital in the UK, you can push a button and videoconference with your nurse, who can see you and walk you through any problems. This looks like a great way to help new folks at home.
Hemotech’s venous needle won’t fall out!
Venous needle dislodgment can be fatal. And, since the pressure of blood returning to the body is negative, the machine may not alarm. Hemotech, a start-up in Sonoma County, CA, is working on a prototype of a new needle that will detect blood leaks—and stop the flow of blood.
First US human testing of the Wearable Artificial Kidney
The University of Washington is the first testing site for the Wearable Artificial Kidney (WAK) in up to 16 people. The battery powered device will continuously filter and reuse water, so it weighs just 10 lbs—but may get even lighter. See it for yourself.
Baxter’s Vivia home HD machine outside the US
Home HD trend lines outside the US are climbing! In England, about 4% of dialysis consumers use home HD (that’s about 4 times the US rate). Canada is at about 5%, and Sweden is close to 6%. In Australia,10% of people with ESRD use home HD. Baxter’s Vivia machine (approved in Europe but not yet in the US) is taking advantage of this trend.
What can Optiflow do for you?
Apparently, veins and arteries don't like being connected together to make an AV fistula. Optiflow is a mechanical connector that takes the place of sutures and helps keep the connection open.
Baxter’s New Vivia Home HD Machine is (Almost) Here!
Baxter presented human studies data at the ERA-EDTA Congress in Amsterdam this June supporting the safety and efficacy of the new Vivia home dialysis system. With four treatments per week for 10 weeks, averaging 3.8 hours per treatment, the mean weekly Kt/V of the 22 US patients was 2.97, with no serious adverse events related to the machine. A small nocturnal trial was also done in Canada.
A whole new 3D take on a dialyzer
A UCSD lab has already shown that it can use 3D printing with a soft hydrogel and living cells to form blood vessels. Now, researchers are using this technique to remove toxins from the body. Nanoparticles that can trap toxins are embedded in a hydrogel matrix. The gel turns red when toxins are present. Once the toxins are removed, the gel matrix can be turned off. This discovery may one day lead to entirely new ways to clean the blood after kidney or liver failure.
New portable artificial kidney trials to start in 2017
A wearable dialysis device prototype is targeted for next year, with clinical trials just 3 years off. A joint effort with Debiotech, AWAK, and Neokidney Development, the new device will be able to do longer and/or more frequent home HD. The system will be based on Debiotech’s DialEase. With AWAK’s sorbent equipment, just 4 liters of dialysate will be needed. Neokidney Development offers access to expert doctors, patients, and help to raise funding for the project.
For a new PD cycler, less will be more
Imagine travel with a PD cycler that weighs less than 10 lbs. (4.5 kilos). But, wait, there’s more. Debiotech’s DialEase will have audio and video guides, built-in videoconferencing, checks blood sugar and blood pressure, and continuous fluid pressure monitoring. It’s not CE Mark or FDA approved yet, but it sure looks cool!
Wait, Another WAK?
Nephron+ is developing a wearable artificial kidney in Europe. Supported by an EU research consortium, the device is currently in animal trials before being tested in humans, and will send patient data to a smartphone. With fewer staff, medications, and infrastructure, the WAK device is expected to save billions of Euros each year compared to dialysis, while allowing patients a more normal life.
Congress Previews an Exciting Kidney Innovation
What could be more home for dialysis than an artificial implantable kidney? Shuvo Roy, PhD and William Fissell, MD showed members of Congress an implantable model kidney not much bigger than an iPhone.
10-lb WAK "toolbelt" device is being tested in WA state
The Kidney Research Institute in Seattle is helping to test a wearable artificial kidney developed by Dr. Victor Gura. The study will look at safety, effectiveness, and quality of life of the new device.
New, mystery dialysis machine from Premier Biomedical
Whatever a "sequential dialysis machine" is (patent-pending, of course), Premier Biomedical has signed an agreement with Printed Device Concepts in El Paso to produce it. Hmmm.
Nanofiber mesh could be a cheaper option than dialysis
Researchers from Japan have developed a nanofiber mesh that contains absorbent minerals to soak up waste products from the blood. The new material can remove creatinine, and now will be tweaked to clean up other wastes as well. The goal is to have dialysis that is so small it can be worn on an arm.
Bioprinting with living "ink" may lead to transplantable human organs
3D printing has already created a human trachea built out of stem cells that has saved the life of a 2-year old. The new technology allows printing of tissue samples that can be kept alive on a microchip, using a blood substitute. Currently, printing is limited to one cell thickness deep, or the cells suffocate—but a Virginia foundation has offered a $1million dollar prize for the first 3D printed working liver, and perhaps kidneys will be next.
WAK Human Trials Approved
A wearable artificial kidney (WAK) is one step closer, with FDA approval of human clinical trials. The WAK is one of three kidney related products that has been fast-tracked by the FDA under a new program.
New Membrane Could Lead to Portable Dialyzers
"If patients are able to undergo dialysis more frequently and/or for longer periods of time, their fluid balance is better. The waste products in the blood do not accumulate between treatments and this means that patients feel better." So says Dr. Dimitrios Stamatialis, who is heading up a Dutch effort to develop new, biocompatible membranes, with the goal of lightweight, portable dialysis.
Wristwatch-sized Device Planned to Remove Uremic Toxins
A Japanese nanofiber polymer mesh is a new approach to toxin removal. Instead of diffusion, the mesh attracts and holds toxins with zeolites—adsorbent minerals. It's been tried on creatinine, but zeolites vary in their pore sizes to remove other toxins as well. The goal is a wristwatch-sized device that can be attached to a vascular access.
Europe gets a new home HD machine—maybe the US will be next!
Baxter has CE Mark approval for a new home HD machine that can deliver flex treatments—short daily, extended, and more frequent than the (unfortunately) standard 3 times a week. The system is user-friendly, with a touch screen, animated step-by-step instructions, a sensor that will stop the blood pump if a needle dislodges, wireless monitoring, and more. We hope the US will see this new technology next!
Australia technology to get patients home and help them stay there.
Telehealth, with remote monitors and video conferencing is being tested to boost home dialysis rates in Australia. The aim is to reach from the current level of 15% home dialysis patients in Victoria to the new Department of Health benchmark of 30-35%. The system collects weight and blood pressure data, which are looked at by a renal nurse. Video conferences help patients review needling and let nurses see exit sites to watch for infection.
A country with twice as many new dialysis patients/year as the US is aiming small
Each year in India, nearly 200,000 people start dialysis. Medtronics is working with Apollo Hospitals to build a portable HD system that will cost less to run than current machines. They expect the new machine to be ready in about 3 years.
Ooh, a mobile app approach to help more patients dialyze at home...
A Sault St. Marie, Canada company called eQOL is working on iPad and other mobile apps to help people with chronic disease take care of themselves and transition out of hospitals to home. Their new DiCAT (Dialysis Platform for Communication, Assistance, and Training) product will help support people on home dialysis.
Learn what a self-assembling, nano material might do for you one day
Bioartificial kidneys made out of a new, self-healing polymer would have less chance of rejection, say scientists. The new material is being tested to design and mimic human cells—and they build themselves. If this process works, it could be a way to offer portable dialysis, aid transplant, or help form a new type of sutures for surgery.
New partners plan to build a miniature home HD machine!
AWAK's loss may be your gain. The Singapore-based company ran out of funding for a wearable artificial kidney—but has reinvented itself in a new partnership with Swiss Debiotech to create an "extremely small and convenient to use" home HD machine based on sorbent technology.