Thubrikar Completes Initial CE Mark–Enabling TAVI-1 Study for Optimum TAV System

October 21, 2022—Thubrikar Aortic Valve, Inc., announced that it has completed the initial study to support CE Mark approval for the Optimum TAV transcatheter aortic valve in patients with severe aortic stenosis.

According to the company, the implantations were performed by Principal Investigator Jarosław Trębacz, MD, at the Specialty Hospital Jana Pawla II in Krakow, Poland. In December 2021, the company announced that the five-patient study was approved by the Competent Authority of Poland. It was conducted in accordance with the European Union’s Medical Device Regulations and monitored by KCRI, the clinical research organization.

The company stated that valve performance has been outstanding, with single-digit mean gradients and effective orifice areas of the aortic valves better than most commercially available transcatheter aortic valve replacement (TAVR) devices.

“With over 14 years of my personal TAVR experience with all CE-Marked devices, I now start to believe that Optimum TAV has the potential to combine the advantages of both a balloon- and a self-expandable valve,” commented Dr. Trębacz in Thubrikar’s press release.

Thubrikar Aortic Valves stated that the short-profile, self-expanding Optimum TAV provides easy coronary access as well as the benefits of a self-expanding valve. It is designed to mimic the natural aortic valve with dimensional proportionality and leaflet surface geometry, no suture holes in the flexion zone of the leaflet, and a unique anticalcification treatment.

The Optimum TAV has shown preclinical durability up to 24 years, with less calcification than established bioprosthetic surgical heart valves. Optimum TAV is intended to meet the needs of a younger patient population requiring a long-lasting valve with excellent hemodynamic performance. In Brazil, the first patient implanted with Optimum TAV continues to do well at 4 years, noted the company.

Mano Thubrikar, PhD, is the inventor of the Optimum TAV, as well as Founder and President of Thubrikar Aortic Valve, Inc., which is based in Norristown, Pennsylvania.

“We are delighted with these initial results at 1-month and 6-month outcomes,” commented Dr. Thubrikar in the company’s press release. “These were truly real-world patients including those with horizontal aorta, eccentric or no calcium burden, and small aortic annulus. The unique short frame and self-expanding technology of the Optimum TAV performed very well in this complex group of patients, and we look forward to expanding enrollment throughout Europe to obtain CE Mark approval.”