Privately held medical device developer Thubrikar Aortic Valve said yesterday that it launched a Brazilian trial of its Optimum transcatheter aortic valve using the company’s implantation system.
The Norristown, Penn.-based company touted that the first human implant has been performed in the trial, which is being sponsored by the company’s Brazilian licensee, Labcor Laboratórios, who also manufactured the valve.
“We are very pleased to initiate this clinical trial of the licensed technology from Thubrikar and anticipate completion of the trial in 2019,” Labcor co-founder Dr. Ivan Casagrande said in a prepared statement.
“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. Joaquin Coutinho of Pedro Ernesto said in prepared remarks.
The first implantation in the trial was performed by a team proctored by NYU Langone Health heart valve center director Dr. Mathew Williams, Thubrikar said, and took place at Rio de Janeiro’s Hospital Universitario. The valve was implanted percutaneously through the femoral artery, and the patient experienced no complications, the company said.
“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 eight 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,” founder & prez Dr. Mano Thubrikar, who invented the device, said in a press release.