TricValve® Transcatheter Bicaval Valves System Receives CE Mark


OrbusNeich® Medical Company Ltd. and P&F Products & Features®, under the joint partnership OrbusNeich P&F, has received CE mark approval for its TricValve® Transcatheter Bicaval Valves System.

The TricValve® Transcatheter Bicaval Valve (bioprosthesis) is developed for the treatment of caval reflux present in cases of severe tricuspid regurgitation, without removal of the defective tricuspid valve. The bioprosthesis is available in different diameters for each model (SVC and IVC) and specifically designed to adapt to the anatomic features of the superior and inferior vena cava.

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

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

“Receiving CE mark reinforces our joint mission to urgently deliver this technology to patients around the world and we are excited to get started,” added Siegfried Einhellig, President and COO of P&F.

About OrbusNeich P&F

In November 2020 OrbusNeich and P&F entered into an agreement for the exclusive distribution and manufacturing of a range of innovative minimally invasive heart valve products in the Asia Pacific region, including China, Japan, Taiwan, South Korea, Hong Kong, Macau, Singapore, Malaysia, Australia and New Zealand.

About OrbusNeich

OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current product portfolio include the world’s first dual therapy stents, the COMBO® Plus and COMBO® Dual Therapy Stents, together with coronary stent, Azule®, specialty balloons, balloons, and microcatheters marketed under the names of Scoreflex®, Scoreflex® NC, Sapphire® II, Sapphire® II PRO, Sapphire® 3, Sapphire® NC, Sapphire® NC Plus, Sapphire® II NC, Sapphire® NC 24, Teleport® and Teleport® Control as well as products to treat peripheral artery disease: the Jade® and Scoreflex® PTA balloons.

OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and regional sales offices in Germany, France, Switzerland, Spain, Japan, Hong Kong, Singapore, and Malaysia. OrbusNeich supplies medical devices to physicians in more than 60 countries. 

Cardiology Magazine


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