Thubrikar Aortic Valve Completes CE Mark-Enabling Study

Thubrikar Aortic Valve, a privately held medical device company, recently announced the completion of the initial CE Mark-enabling study (NCT04076150) using its Optimum Transcatheter Aortic Valve (Optimum TAV) in patients with severe aortic stenosis. The five patient study was performed in Krakow, Poland, by principle investigator Jaroslaw Trebacz, MD, at the Specialty Hospital Jana Pawla II, and approved by the Competent Authority of Poland, conducted in accordance with EU MDR, and monitored by Thubrikar Aortic Valve’s CRO, KCRI.

Optimum TAV is a short-profile, self-expanding TAV that provides easy coronary access as well as the benefits of a self-expanding valve, according to the company. Additionally, it is designed to mimic the natural aortic valve with dimensional proportionality and leaflet surface geometry, has no suture holes in the flexion zone of the leaflet, and a unique anti-calcification treatment.

With pre-clinical durability shown up to 24 years, Optimum TAV demonstrated less calcification than established bioprosthetic surgical heart valves. The valve is intended to meet the needs of a younger patient population requiring a long-lasting option with excellent hemodynamic performance.

“We are delighted with these initial results at 1-month and 6-month outcomes,” said Dr. Mano Thubrikar, Optimum TAV’s inventor, and the company’s president and founder. “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 these complex group of patients, and we look forward to expanding enrollment throughout Europe to obtain CE Mark approval.”

Previously, the company released positive 30-day outcomes in the first two patients receiving the valve, showing significant clinical improvement evidenced by qualitative improvements in valvular pressure gradients and effective orifice areas. These patients reportedly met all primary outcomes and were free of all-cause mortality, stroke, major bleeding, pacemaker implantation, moderate to severe regurgitation, and vascular complications three months following implantation. Additionally, patient quality of life improved significantly.

Original Article: (https://www.mddionline.com/technologies/thubrikar-aortic-valve-completes-ce-mark-enabling-study)