Articles from Thubrikar Aortic Valve, Inc.

Thubrikar Aortic Valve, Inc. today announced its partnership with MAC’s MEDICAL Group, a distributor of cardiovascular devices in Europe, and MAC’s CEO, Ante Cicin-Sain. As part of the exclusive distribution rights agreement for Europe, Mr. Cicin-Sain, MAC’s MEDICAL Group, and their affiliates will co-participate in financing up to 50 implants toward the CE Mark approval of the Optimum TAVI System™. They will also have the option to invest an additional $2 Million in Thubrikar Aortic Valve (the “Company”).

Thubrikar Aortic Valve, Inc. today announced successful results in an additional 5 patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the Precision 2™ Delivery Catheter. These procedures demonstrated excellent performance of both the valve and delivery catheter, despite the anatomical challenges presented by the patients.

Thubrikar Aortic Valve, Inc. today announced successful results in the first two patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the new Precision 2™ Delivery Catheter. Interventional Cardiologist and TAVI-1 Study Principal Investigator, Jaroslaw Trebacz, MD, performed the procedures at the John Paul II Hospital in Krakow, Poland. “The first two implants with the 2nd-generation delivery catheter could not be easier or more effective. From the operator's perspective, it felt like a surprisingly mature and user-friendly device. I’m truly looking forward to the next cases,” stated Dr. Trebacz.

Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™). The authorization allows for an additional 15 patients to be treated with the Optimum TAV™ using the Company’s 2nd-generation delivery catheter, the Precision 2™ Catheter.

Thubrikar Aortic Valve, Inc., is happy to announce that results of the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis will be presented at the upcoming EuroPCR 2023 Conference. EuroPCR is an annual, world-leading conference on interventional cardiovascular medicine taking place from May 16-19, 2023, in Paris, France. Principal Investigator and Interventionalist, Jaroslaw Trebacz, MD, of the Specialty Hospital Jana Pawla II in Krakow, Poland, will discuss their experience and follow-up data up to one year during the moderated “TAVI: Late-Breaking Trials and Innovations” session.

Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis. The implantations were performed by the Principal Investigator Jaroslaw Trebacz, M.D., at the Specialty Hospital Jana Pawla II, Krakow, Poland. The 5-patient study was approved by the Competent Authority of Poland, conducted in accordance with EU MDR, and monitored by the Company’s CRO, KCRI.

Thubrikar Aortic Valve, Inc., announced today successful 30-day outcomes in the first two patients receiving the Optimum Transcatheter Aortic Valve (Optimum TAV™). The implantations were performed by the Principal Investigator, Jaroslaw Trebacz, MD, at the Specialty Hospital Jana Pawla II, Krakow, Poland. The study was approved by the Competent Authority of Poland and conducted in accordance with EU MDR. Mathew Williams, MD, Director of the Heart Valve Center at NYU Langone Health, USA, proctored the implant team of an interventional cardiologist and a cardiac surgeon. Three more patients are expected to receive the Optimum TAV in the coming weeks.

Thubrikar Aortic Valve, Inc., announced today that it received approval from a Competent Authority in Poland to conduct initial patient implants with its Optimum Transcatheter Aortic Valve Implantation (TAVI) system™. The Company will sponsor this CE Mark-enabling pilot study on patients with severe Aortic Stenosis and begin to implant the first five patients in early 2022.