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