Thubrikar Optimum TAV System With New Precision 2 Delivery Catheter Studied in Poland

May 13, 2024—Thubrikar Aortic Valve, Inc. recently announced that the first two patients have received implantations with the company’s Optimum transcatheter aortic valve (TAV) using its new Precision 2 delivery catheter. The company is continuing to enroll up to a total of 20 patients in Poland of the Optimum TAV transcatheter aortic valve replacement (TAVR) system.

In December 2023, Thubrikar Aortic Valve announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the company’s Optimum TAV, which allowed for an additional 15 patients to be treated with the Optimum TAV device using the company’s Precision 2 second-generation delivery catheter.

The company stated that it plans to expand the Optimum TAV system’s CE Mark trial to two additional countries in Europe.

Interventional cardiologist Jaroslaw Trebacz, MD, who is the TAVI-1 study Principal Investigator, performed the TAVR procedures at the John Paul II Hospital in Krakow, Poland.

“The first two implants with the second-generation delivery catheter could not be easier or more effective,” commented Dr. Trebacz in the company’s press release. “From the operator’s perspective, it felt like a surprisingly mature and user-friendly device. I’m truly looking forward to the next cases.”

According to Thrubikar, the eight patients that have been implanted with the Optimum TAV have shown that postimplantation mean pressure gradients and effective orifice areas were superior to those published on other TAVR devices of comparable size. Additionally, the Optimum TAV demonstrates preclinical durability surpassing that of even surgical bioprosthetic valves, which are thought to be more durable than transcatheter valves.

With the Precision 2 catheter design and the Optimum TAV’s short frame, the valve reorients as it is deployed resulting in automatic axial alignment with the native valve.

The device features a self-expanding design that is less than half the height of commercial self-expanding platforms, allowing full access for future coronary interventions. The Optimum TAV may also be used to treat patients with a failed surgical or transcatheter valve, advised the company.