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TricValve Transcatheter Bicaval Valves System Receives CE Mark

May 23, 2021


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

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. 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.” -Dr Shaiful Azmi Yahaya, Head of the Cardiology Department at the National Heart Institute, Kuala Lumpur, Malaysia

“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.” – 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.” – Siegfried Einhellig, President and COO of 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.

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.

See Full Press Release at the Source: TricValve® Transcatheter Bicaval Valves System – OrbusNeich

Press Release by: OrbusNeich

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