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Devices Interventional Cardiology Regulatory

 News Release - May 20, 2021

TricValve(R) Transcatheter Bicaval Valves System Receives CE Mark

HONG KONG, May 20, 2021 -- (Healthcare Sales & Marketing Network) -- 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," 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. For more information, visit www.OrbusNeich.com.

About P&F Products and Features

With more than 25 years of experience in the medical field, the leadership team of P&F has built a complete infrastructure for research, development, manufacture, and distribution in order to deliver significant innovations and add value to its customers and patients. P&F is striving to become the "standard of comparison" in the development of state-of-the-art innovative technologies in the field of cardiology products that contribute to human welfare by the application of biomedical engineering in the research, development and manufacture of devices which restore health, extend life and are accessible to all.

The company's lead product, TricValve®, is a bicaval, biological, minimally invasive valves system for the treatment of severe tricuspid insufficiency. The further pipeline includes biological heart valves like the TAVI system Vienna Aortic Self-Expandable Transcatheter Valve, a Pulmonary Valve and Mitral Valve as well as Aortosave®, a minimally invasive device to treat Type A aortic dissections, as well as the full portfolio of endovascular grafts. The proprietary Dry Pericardium technology platform enables off the shelf use of the company's heart valves.

Headquartered in Vienna, Austria, under the leadership of Prof Dr Katharina Kiss and Prof Dr Siegfried Einhellig, P&F coordinates worldwide operations. For more information, visit https://productsandfeatures.com.


Source: OrbusNeich Medical

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