Q&A: Implantable dialysis device receives FDA breakthrough status

In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage kidney disease, according to a company press release.
The Holly device by Nephrodite, a medical device company, is described as an “implantable, continuous dialysis system,” according to the release. The device received FDA breakthrough designation based on data from a multiday large animal study, demonstrating “strong safety and performance outcomes,” the release said.
“We’re excited to receive breakthrough status,” Nikhil Shah, DO,


