AsiaNet 89619

HONG KONG, May 20, 2021 /PRNewswire=KYODO JBN/ --

OrbusNeich(R) Medical Company Ltd. and P&F Products & Features(R), under the

joint partnership OrbusNeich P&F, today announced that the TricValve(R)

Transcatheter Bicaval Valves System has received CE mark approval.

The TricValve(R) 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(R) Plus and COMBO(R) Dual Therapy

Stents, together with coronary stent, Azule(R), specialty balloons, balloons,

and microcatheters marketed under the names of Scoreflex(R), Scoreflex(R) NC,

Sapphire(R) II, Sapphire(R) II PRO, Sapphire(R) 3, Sapphire(R) NC, Sapphire(R)

NC Plus, Sapphire(R) II NC, Sapphire(R) NC 24, Teleport(R) and Teleport(R)

Control as well as products to treat peripheral artery disease: the Jade(R) and

Scoreflex(R) 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(R), 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(R), 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