OrbusNeich P&F’s TricValve Transcatheter Bicaval Valves System Receives CE Mark Approval

May 20, 2021—OrbusNeich Medical Company Ltd. and P&F Products & Features, under the joint partnership OrbusNeich P&F, announced that the TricValve transcatheter bicaval valves system has received European CE Mark approval.

According to the companies, the TricValve bioprosthesis is intended for the treatment of caval reflux present in cases of severe tricuspid regurgitation without removal of the defective tricuspid valve. The device is available in different diameters for each model—the SVC and the IVC—and is specifically designed to adapt to the anatomic features of the superior vena cava and inferior vena cava.

“TricValve is a safe and simple valve system for patients with severe tricuspid regurgitation,” commented Shaiful Azmi Yahaya, MD, in the announcement. Dr. Yahaya, who is Head of the Cardiology Department at the National Heart Institute in Kuala Lumpur, Malaysia, added “TricValve provides a new treatment option for patients [who] are not suitable for surgery, as well as patients with very dilated annulus or very large coaptation gap, or even with a pacemaker.”

In November 2020, OrbusNeich and P&F entered into an agreement for the exclusive distribution and manufacturing of a range of heart valve products in the Asia Pacific region, including China, Japan, Taiwan, South Korea, Hong Kong, Macau, Singapore, Malaysia, Australia, and New Zealand, advised OrbusNeich P&F. On December 22, 2020, P+F Products + Features GmbH announced that the FDA has granted Breakthrough Device designation for the company’s TricValve transcatheter bicaval valves system.