A clinical trial examining the use of Thubrikar Aortic Valve’s transcatheter aortic valve implantation (TAVI)system has been given the greenlight to expand its remit by the Polish authorities.
Thubrikar Aortic Valve said it received authorisation from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of its Optimum Transcatheter Aortic Valve Implantation System, allowing for an additional 15 patients to join the trial.Patients will be treated with Optimum using Thubrikar’s delivery catheter, the Precision 2 Catheter.
Data from the first five patients participating in the TAVI-1 trial, found there was clinical improvement within one year, with patients achieving freedom from being re-hospitalised due to complications following the implantation of the valve.
Founder and president of the company, Mano Thubrikar, said: “We have completed 1-year follow-up on 5 patients in Poland, and the data on pressure gradient and effective orifice area of the Optimum TAV is superior to that published on any transcatheter aortic valve of comparable size.
“The one and five-year patient outcomes are a testament to the superior design of the Optimum TAV. For the ongoing evolution of TAVI, the Optimum TAV has the durability required for younger patients. We look forward to bringing this technology to more patients and demonstrating the control offered by our new Precision 2 Catheter.”
Thubrikar Aortic Valve is entering a competitive market. Ireland-based Vivasure Medical is also aiming to complete a US-based pivotal study investigating its absorbable synthetic implant.
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According to a report by GlobalData, in 2023 the market for transcatheter aortic valve replacements stood at an estimated $6.8bn, with that figure expected to grow to $12.5bn by the end of 2030.