CVS Health launches clinical trial for new home dialysis machine
CVS Health is starting clinical trials on its new HemoCare Hemodialysis System, a dialysis machine developed for home use in partnership with Segway designer Dean Kamen.
Kamen and his company, DEKA Research & Development Corp., had originally worked with Baxter Renal Care to develop a version of the machine, called the Vivia, and clinical trials were launched in March 2016. However, Baxter ended the trials shortly thereafter because of technical problems.
The new clinical trial will include up to 70 patients and will be conducted at up to 10 sites in the United States, CVS Health said in a statement.
“We’re working now to change the kidney care paradigm by bringing to market programs and tools to improve early detection of kidney disease and provide comprehensive education and support to help delay the transition to dialysis,” Alan Lotvin, MD, executive vice president and chief transformation officer at CVS Health, said in the release. “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.”
During the trial, investigators will measure the safety and performance of the HemoCare Hemodialysis System. In the initial phase of the trial conducted at dialysis facilities, clinical study patients and their caregivers will receive training on the system and will then transition to home-based dialysis. Primary study endpoints include adverse events, as well as regular tests, to measure the dose efficacy of dialysis delivered by the device, CVS Health said.
“DEKA designed this device with patients in mind to help make home dialysis safe and simple,” Kamen said in the release. “CVS Health is uniquely positioned to redefine identification, education and treatment for chronic kidney disease, making them our ideal partner.”
The HemoCare Hemodialysis System would be used in conjunction with an early kidney disease identification and stratification programs developed by CVS Kidney Care for patients with CKD. CVS Kidney Care will also support other treatment options, such as transplant and PD.
The company said its efforts at tracking CKD are tied with the announcement on July 10 by the Trump administration to provide more incentives to nephrologists to treat kidney disease in earlier stages.
“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.
CVS Health has more than 9,900 retail locations, approximately 1,100 walk-in medical clinics, a leading pharmacy benefits manager with approximately 94 million plan members, a dedicated senior pharmacy care business serving more than one million patients per year and expanding specialty pharmacy services.