Thubrikar Aortic Valve has announced a partnership with Mac’s Medical Group, a distributor of cardiovascular devices in Europe, allowing it to expand the CE mark trial of its investigational transcatheter aortic valve implantation (TAVI) system.
Mac’s Medical Group and affiliates will participate in financing up to 50 implants toward the study of the Optimum TAVI system—ahead of its expansion into Croatia, Serbia and other countries—with an option to invest an additional US$2 million in the company.
An investment from Mac Medical’s CEO Ante Cicin-Sain has facilitated three recent implants in Poland, supplementing investment from Labcor Laboratorios of Brazil; affiliates of China Cardiovascular Research Foundation; and multiple angel groups and individual investors.
Mano Thubrikar, founder and president of Thubrikar Aortic Valve, said: “We are very excited to partner with Mac’s Medical Group for expanding and supporting the completion of our CE mark trial, and for their vast experience with European marketing and sales of implantable cardiovascular devices.”
Interventional cardiologist and TAVI-1 CE mark trial principal investigator, Jaroslaw Trebacz, conducted the procedures at the John Paul II Hospital (Krakow, Poland).
“The haemodynamic performance of the Optimum Valve has been outstanding in all patients throughout up to four years of follow-up,” Trebacz was quoted as saying. “In particular, the results are exceptionally encouraging when compared with my extensive experience over many years using commercially available devices in patients with similarly small annuli. The consistently excellent outcomes observed with the Optimum Valve underscore its remarkable effectiveness in this challenging patient population.”
Optimum TAV is described by Thubrikar Aortic Valve as the only short-frame, self-expanding TAVI valve. The design of the valve is intended to facilitate full coronary access. The valve mimics the optimal geometry and leaflet dynamics of the natural aortic valve and has no suture holes in the flexion zone.
To date, the Optimum TAV has been successfully implanted in 16 patients. Data on the device’s performance from a first-in-human study are expected to be submitted for publication to JACC: Cardiovascular Interventions.
