JenaValve Technology has announced the successful first cases and official US commercial launch of its Trilogy transcatheter heart valve (THV) system.
This follows the US Food and Drug Administration’s (FDA) recent premarket approval (PMA) for Trilogy for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) who are at high or greater risk for surgical aortic valve replacement (SAVR).
The first commercial US procedures were performed simultaneously at NewYork-Presbyterian/Columbia University Irving Medical Center by Torsten Vahl, at Cedars-Sinai Medical Center by Raj Makkar and at Piedmont Heart Institute by Vinod Thourani.
The Trilogy THV system is the first and only transcatheter device in the USA with a dedicated indication for high-risk aortic regurgitation (AR)—a historically underserved and underdiagnosed patient population that, until now, had no approved transcatheter treatment option.
“It is an honour to have been on this journey with Trilogy from the very first implants of the ALIGN-AR trial to FDA approval and the very first commercial implants,” says Vahl, national principal investigator (PI) of the ALIGN-AR trial. “This is a significant achievement for the field and more importantly, for the many thousands of high-risk AR patients that finally have TAVI [transcatheter aortic valve implantation] available as an option to them.”
“These first cases are a defining moment for the many Americans who have been suffering from severe aortic regurgitation,” says Makkar, the highest enroller in the ALIGN-AR trial. “I have seen firsthand how many patients need a dedicated treatment option like Trilogy. With this groundbreaking FDA approval and commercial launch, I believe we will soon gain a clearer understanding of how many patients can truly benefit from this important therapy.”
“We finally have the option of TAVI for AR patients at high-risk of surgery,” said Thourani, national PI of the ALIGN-AR trial. “I am excited for what this means for the future of AR treatment because this now opens the door to whether or not we expand this treatment beyond high-risk patients. The randomised ARTIST trial which we are enrolling now will give us the critical answers to that question.”
“The commercial launch of Trilogy in the USA is the beginning of a transformation in how we identify, diagnose, and treat aortic regurgitation,” said Peter Spadaro, chief commercial officer of JenaValve. “We have assembled a world-class commercial organisation to introduce the Trilogy valve to hospitals throughout the country to ensure patients have access to this therapy. The unmet need is enormous, and we are already experiencing strong demand. We are committed to reaching every patient who can benefit from the Trilogy system, while prioritising patient outcomes and safety as we expand access to this game-changing technology.”
