FIH Implantation Performed With Thubrikar's Optimum TAV System

January 14, 2019—Thubrikar Aortic Valve, Inc. announced the first-in-human (FIH) implantation of its Optimum transcatheter aortic valve (TAV) system. The procedure initiates a clinical trial sponsored by the company’s Brazilian licensee, Labcor Laboratórios Ltda., which manufactured the implanted valve designed by Thubrikar. The trial is anticipated to be completed in 2019.

Mathew Williams, MD, Director of the Heart Valve Center at NYU Langone Health in New York, New York, proctored the team of cardiac surgeons and interventional cardiologists who performed the implantation at the Hospital Universitario Pedro Ernesto in Rio de Janeiro, Brazil.

The patient is a 79-year-old woman with severe aortic stenosis. The Optimum TAV device was percutaneously implanted through the femoral artery. The patient experienced no complications, was discharged home, and is doing very well. The Optimum TAV device was functioning very well without any leaks, reported the company.

Mano Thubrikar, MD, is the inventor of the Optimum TAV system and the Founder and President of Thubrikar Aortic Valve, Inc., which is a privately held medical device company based in Norristown, Pennsylvania.