Thubrikar Aortic Valve, Inc., a privately held medical device company, today announced the first human implant of the Optimum TAV using their transcatheter aortic valve implantation (TAVI) system.
The implant commences a clinical trial sponsored by the Company's Brazilian licensee, Labcor Laboratórios Ltda., who manufactured the implanted valve designed by Thubrikar.
Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health in the U.S., proctored the team of cardiac surgeons and interventional cardiologists, that included Dr. Gustavo Kikuta, Dr. Pedro Jazbik, and others, to do the implant at the Hospital Universitario Pedro Ernesto in Rio de Janeiro, Brazil, 3 weeks ago. Other participants from Thubrikar were Samuel Evans, Jason Mattis, Mano Thubrikar, and Dr. Vishal Thubrikar.
The patient is a 79-year-old woman with severe aortic stenosis. The "Optimum TAV" valve was implanted percutaneously through the femoral artery. She experienced no complications and was discharged home and is doing very well. The Optimum TAV was functioning very well without any leak.
Dr. Ivan Casagrande, co-founder of Labcor said, "We are very pleased to initiate this clinical trial of the licensed technology from Thubrikar and anticipate completion of the trial in 2019."
Dr. Joaquin Coutinho, Head of Cardiac Surgery at Pedro Ernesto, said "We are particularly excited to witness the success of the FIH of this important next-gen TAVI system, and we look forward to participating in Labcor's clinical trial of these devices in Brazil."
Dr. Mano Thubrikar, inventor of the Optimum TAVI system and the Company's Founder and President stated, "Our system has demonstrated initial clinical feasibility and we look forward to ongoing clinical data of our technologies from Labcor. For a smaller company with less resources than many others in the TAVI field, for us to do FIH in 8 years with a resounding success is making history. Furthermore, our preclinical data shows that our valve is comparable to surgical valves in durability, thus overcoming the last road block for TAVI to be used in younger patients."
The worldwide patient population for severe aortic stenosis is estimated at over 400,000 per year which explains the extensive effort being made by many large multinational medical companies, as well as several start-up venture companies that have focused for the last decade on aortic valve replacement using a transcatheter approach which avoids open heart surgery. However, many of the start-ups have had to end and/or restart their program because of their valve's compromised function. As long-term data becomes available and a more durable TAV arises, TAVI is expected to replace surgery for nearly all aortic valve replacements.