CVS launches home hemodialysis device clinical trial

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Dive Brief:

  • CVS Health announced on Wednesday the start of a clinical trial of up to 70 patients to evaluate the safety and performance of a home hemodialysis device the company intends incorporate into its CVS Kidney Care initiative.
  • The HemoCare Hemodialysis System, developed in partnership with the DEKA Research & Development Corp., aims to be part of the shift from delivery of dialysis from clinics to the home setting.
  • The move comes a week after President Donald Trump signed an executive order to incentivize the use of home dialysis to cut down on health spending. Currently, nearly 90% of dialysis care is rendered at clinics, but HHS hopes to flip that number; the department wants 80% of Americans receive dialysis at home or receive a viable organ transplant by 2025.

Dive Insight:

CVS, which now includes insurance giant Aetna, argues it can help the government reduce costs associated with the treatment of end stage renal disease, which costs Medicare about $35 billion per year.

The clinical trial for the HemoCare Hemodialsyis System was first hinted at last April, when CVS said it was developing a home hemodialysis device it intends to submit a 510(k) application for to FDA. The clinical trial will be held across 10 sites across the U.S., with patients being monitored for adverse events and dose efficacy of the dialysis by the device.

CVS said its kidney care efforts were initially focused on early disease identification and patient education, but the second stage is a home dialysis program for both hemodialysis and peritoneal dialysis. 

Peritoneal dialysis, which uses a catheter and cleansing fluid to clean patient blood, currently accounts for 78% of the home dialysis market, according to a recent note from RBC Capital Markets. Conversely, hemodialysis uses an artificial kidney machine to pump blood out of a patient to clean the blood before returning it to the body.

Traditional dialysis centers have made inroads to home care as well.

Fresenius Medical Care, one of the largest operators of dialysis clinics, completed its acquisition of home hemodialysis device maker NxStage for $2 billion in February.

“This acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies,” Fresenius CEO Rice Powell said at the time. 

On the peritoneal dialysis front, Baxter said last week it plans to significantly invest into its products in an effort to take advantage of HHS’ push to overhaul kidney care.

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