A week after President Donald J. Trump signed an executive order directing improvement in diagnosis and treatment of patients with kidney diseases and emphasizing increased use of home dialysis, CVS Health announced the start of a clinical trial into the safety and efficacy of a new home system, the HemoCare Hemodialysis System.
The trial is expected to enroll 70 patients at 10 U.S. sites.
In April 2018, CVS, the chain pharmacy giant cum healthcare company based in Woonsocket, RI, announced it would initiate a clinical trial “to demonstrate the safety and efficacy of a new home hemodialysis device in support of a planned FDA submission to obtain market clearance.” At that time, the company said the device was designed to make home hemodialysis “simple and safe for patients, in order to facilitate longer, more frequent treatments.”
Now CVS has announced that DEKA Research and Development Corp. (Manchester, NH), headed by Segway innovator Dean Kamen, designed the home-use device.
Earlier in his career, Kamen invented the Homechoice peritoneal dialysis system (Baxter Healthcare still offers the Homechoice Claria PD system) and the first wearable insulin pump for people with diabetes. Kamen sold his first company, AutoSyringe, in 1982.
“CVS Health is uniquely positioned to redefine identification, education, and treatment for chronic kidney disease, making them our ideal partner,” Kamen said.
Alan Lotvin, MD, executive vice president and chief transformation officer at CVS Health says, “For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options, and we are working closely with the U.S. Food and Drug Administration as we evaluate this device.
“We have been working to fundamentally disrupt the kidney care market and rapidly innovate in an area that has stagnated for decades, and we applaud the administration for taking bold steps toward advancing kidney care as they are helping to rethink how to make kidney transplant and home dialysis mainstays of therapy,” Lotvin said.
The CVS chronic kidney disease (CKD) management program will work with patients to identify and better manage CKD earlier. Once a diagnosis has been made, CVS Kidney Care, in collaboration with healthcare providers, will engage with the patient to educate them about their disease and treatment options, and help them manage their condition, monitor risk factors, and meet their health goals, according to the CVS website.
