First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™

Novel Tria aortic heart valve

Foldax®, Inc. says the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA™ biopolymer surgical aortic heart valve.

Background

First appearing on our pages last year, Foldax claims its TRIA valve “reimagines” the heart valve. It does this by combining the company’s proprietary biopolymer – LifePolymer™ – with an innovative valve design intended to resist calcification, withstand stresses and strains without failure. In so doing it aims to restore patient quality of life without lifelong use of anticoagulants.

The Aortic Valve, reimagined

With the TRIA valve platform, the company intends to reinvent every aspect of the heart valve – from material to design to manufacturing – by developing surgical and transcatheter valves designed to last a lifetime addressing the historical tradeoffs between tissue and mechanical valves.;

The newly reported procedures have been performed by Dr. Kaushal Pandey at P.D. Hinduja Hospital in Mumbai, India.

Clinician comments

“We are honored to be the first center outside of the U.S. to implant the TRIA heart valve. Our first few cases have gone very well – implantation has been successful, early hemodynamic results have been encouraging, and the patients have all been quickly discharged home,” said Dr. Pandey.

“We look forward to completing enrollment in the study in the next few months and seeing how this novel biopolymer heart valve can improve the lives of our patients.”

About the Indian trial

The trial is studying the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and is designed to support commercial approval in India.

Today, 70 percent of aortic valve replacements being performed in India use mechanical valves. Mechanical valves are durable but require life-long anticoagulant use to minimize blood clotting. Anticoagulant therapy creates an ongoing bleeding risk that can limit a patient’s lifestyle, diminish their quality of life, and potentially lead to hemorrhage and death.

In one-year results published last year in JACC: Cardiovascular Interventions, the TRIA biopolymer aortic heart valve met all primary endpoints, including valve effective orifice area (EOA) and clinically significant improvement in New York Heart Association (NYHA) class.

The device remains investigational use only and is not available for commercial sale

Company comments

Foldax CEO Frank Maguire says; “We are excited to be able to offer our novel TRIA valve to patients internationally for the first time. It is uniquely suited to the Indian market, whose dependence on mechanical heart valves  leaves patients with a compromised quality of life. This study is designed to determine the TRIA valve’s ability to offer good hemodynamics and patient improvement safely, without patient dependence on blood thinning medication, which should offer quality of life benefits.”

“Assuming we achieve regulatory approval in India in the future, our robotic manufacturing pod platform is designed to easily and efficiently manufacture the valve anywhere in the world without the need for a large skilled workforce or large manufacturing facilities.”

Source: Foldax, Inc.

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