TricValve® Transcatheter Bicaval Valve System Receives CE Mark Approval

HONG KONG, May 20, 2021 /PRNewswire/ -- OrbusNeich®OrbusNeich Medical Company Ltd. and P&F Products & Features® today announced, on behalf of the partnership OrbusNeich P&F, that the TricValve® transcatheter bicaval valve has received CE Mark approval.

The TricValve® transcatheter bicaval valve (bioprosthesis) is designed to treat caval reflux associated with severe tricuspid regurgitation, without the need to remove the diseased tricuspid valve. Each model (SVC and IVC) is available in various diameters, specifically designed to accommodate the anatomical characteristics of the superior and inferior vena cava.

“TricValve is a safe and simple valve system suitable for patients with severe tricuspid regurgitation,” said Dr. Shaiful Azmi Yahaya, Director of the Cardiology Department at the National Heart Institute, Kuala Lumpur, Malaysia. He added, “TricValve provides a new treatment option for patients who are not suitable for surgery, as well as those with a severely dilated annulus or a large coaptation gap, and even patients with cardiac pacemakers.”

“CE Mark approval represents a new milestone in the structural heart field. We are pleased to offer a new treatment option for patients with severe tricuspid regurgitation and those at high risk for open-heart surgery,” said Alain Khair, Chief Commercial Officer of OrbusNeich.

P&F President and Chief Operating Officer Siegfried Einhellig added: “Obtaining the CE mark reinforces our shared mission to urgently deliver this technology to patients worldwide, and we are excited to begin using it.”