P+F Products + Features GmbH announced that it received FDA breakthrough device designation for its TricValve system.
Vienna-based P+F received the breakthrough nod earlier this month for the transcatheter bicval valves system, comprised of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux, according to a news release.
The system’s bioprostheses are percutaneously implanted into the inferior and superior vena cava without disturbing the native tricuspid valve in patients at extreme risk or who are inoperable for open surgical therapy.
P+F said in the release that the TricValve system is currently in the midst of the CE Mark certification process and it expects to receive European approval in the first quarter of 2021.
“It is a huge milestone to receive the breakthrough device status for the TricValve,” P+F CEO Dr. Katharina Kiss said in the release. “This could be a big change in the treatment of patients with severe TR made in Europe.”