OrbusNeich and P+F today announced they have 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, Singapore, Malaysia, Australia and New Zealand.
OrbusNeich notes P+F will bring to the partnership a series of innovative minimally invasive heart valve products premounted on the delivery system using P+F’s proprietary dry valve technology. The product portfolio includes the TricValve® Transcatheter Bicaval Valves and the Vienna Aortic Self-Expandable Transcather Valve complemented by transcatheter solutions for pulmonary and mitral valve disease as well as endovascular grafts.
The TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux, specifically intended for patients at extreme risk or who are unsuitable for open heart surgery.
The Vienna Aortic Self-Expandable Transcatheter Valve is designed to treat severe aortic stenosis in patients at medium to high risk for open heart surgery. The minimally invasive valve replaces the native aortic valve without the need for concomitant surgical removal. Both systems are pending CE mark approval.
“We are delighted to collaborate with P+F and to establish a strong presence in a large and fast-growing transcatheter heart valve market in Asia Pacific. Both China and Japan face the challenge of a growing elderly patient population with the prevalence of moderate-to-severe dysfunctional heart valves. Our unique product line for percutaneous transcatheter based therapeutics will result in significant improvement of health-related quality of life to our patients, which is an important measure of procedural success in the elderly,” said David Chien, Chairman, President and CEO, OrbusNeich.
“This joint venture brings us one step closer to providing patients in Asia Pacific with P+F’s transformational heart valve solutions and supports our strategy of rapid expansion into key, fast-growing markets, globally. It is the right moment to focus on being the leading player in this region,” said Siegfried Einhellig, President and COO of P+F.
Katharina Kiss, CEO of P+F, commented: “Partnering with OrbusNeich is an ideal opportunity for us to expand our vision by bringing our innovative heart valves technology to patients. My mission as a cardiologist is not only to save lives but to ensure the maximum quality of life for each of our patients and I am convinced that with the joint efforts of this newly founded Asian joint venture we will be able to revolutionize the medical landscape.”
“This powerful partnership supports our strategic business directive to add important complementary structural heart devices to our coronary and peripheral portfolio. We look forward to working with P+F to expand the potential of our combined strengths in the global medical device business,” said Alain Khair, Senior Vice President and Chief Commercial Officer of OrbusNeich.