Collegeville, Pa. — Thubrikar Aortic Valve Inc. has entered into a partnership with MAC’s MEDICAL Group to expand the European CE Mark clinical trial of its Optimum TAVI System.
Under an exclusive European distribution agreement, MAC’s MEDICAL Group, Chief Executive Officer Ante Cicin-Sain and their affiliates will help finance as many as 50 implants in support of the TAVI-1 CE Mark trial. They will also have the option to invest an additional $2 million in Thubrikar Aortic Valve.
MAC’s MEDICAL Group distributes cardiovascular devices in Europe. The company plans to expand the Optimum TAVI System trial into Croatia, Serbia and other European countries.
Cicin-Sain has already financed three recent implants in Poland through an investment in Thubrikar Aortic Valve. The company said the procedures provided additional evidence of the system’s ease of delivery and valve performance.
“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,” said Mano Thubrikar, Founder and President of Thubrikar Aortic Valve.
Jaroslaw Trebacz, principal investigator of the TAVI-1 CE Mark trial, performed the three procedures at John Paul II Hospital in Krakow, Poland.
“The hemodynamic performance of the Optimum Valve has been outstanding in all patients throughout up to four years of follow-up. 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,” Trebacz said.
The Optimum TAVI System consists of the Optimum transcatheter aortic valve and the Precision 2 delivery catheter. The company describes the Optimum TAV as a short, self-expanding valve designed to improve durability and avoid obstructing access to the coronary arteries.
“The Optimum TAV™ and the Precision 2™ Catheter represent a true next-generation system built to offer increased valve durability for all patients,” Thubrikar said.
The Optimum TAV has been implanted in 16 patients to date. The first patient to receive the device globally was reported to be doing well seven years after implantation, according to the company.
Thubrikar Aortic Valve said it plans to submit the clinical data for publication in JACC: Cardiovascular Interventions.
The Optimum TAVI System was also named the “Top Aortic Valve Implantation System 2026” by MED TECH Outlook.
