The Munich-based startup JenaValve is a bit like the tortoise, with a slow and steady approach to transcatheter aortic valve replacement (TAVR) device development.
At the Transcatheter Cardiovascular Therapeutics (TCT) conference today, Dr. Vinod Thourani, co-principal investigator of the ALIGN-AR study, jokingly compared the company’s approach to a “nice bottle of wine” that gets better with age. “You don’t want a wine that’s just one year out. You want something that’s cooked a little bit.”
The company’s origins trace back to a 1995 design concept from Dr. Hans Figulla and Dr. Markus Ferrari of the Friedrich Schiller University. The founders won a patent for their first percutaneous self-expanding aortic stent in 1999. The company was officially founded in 2006. In 2018, the company launched the ALIGN-AR pivotal trial in the U.S. for aortic regurgitation with its transfemoral, porcine pericardial valve. In 2021, it raised a $100M Series C to aim for FDA approval for its Trilogy heart valve system, designed explicitly for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).
“I think that you have to give the company credit for sticking with it,” Thourani said. “It has done this on its own as a startup company.”
JenaValve at TCT: Pioneering new frontiers in aortic regurgitation treatment
The JenaValve Trilogy [Image courtesy of JenaValve]
In a late-breaking clinical trial session at TCT, Thourani noted that 180 high-risk patients with symptomatic, moderate to severe aortic regurgitation with severe symptomatic aortic regurgitation underwent the Trilogy Transcatheter Heart Valve (THV) implementation in the study. The study met its primary safety endpoint, which was to evaluate the safety of the Trilogy THV system at 30 days post-implantation. Regarding efficacy, investigators noted significant improvements in left ventricular systolic diameters, systolic volumes, and mass regression. “You see really significant improvements in the ventricle after having the aortic regurgitation obliterated,” Thourani said. Patients exhibited sustained improvements in both quality of life (QOL) and heart failure functional status over the course of a year.
In the session, Thourani described aortic regurgitation as “a forgotten disease.” While cardiologists have traditionally used TAVR to treat aortic stenosis, the focus on aortic regurgitation, which involves the backflow of blood into the left ventricle as a result of a faulty aortic valve, could open up a new treatment population for TAVR. “I think this is a huge patient population,” Thourani said.
A significant AR prevalence
The incidence of clinically significant aortic regurgitation (AR) increases with age, typically peaking in the fourth to sixth decade of life, according to an article in BMJ. According to an analysis of the Framingham study, AR has an estimated prevalence of 4.9%, with regurgitation of moderate or greater severity occurring in 0.5% of the population.
JenaValve completed enrollment in the ALIGN-AR IDE trial in September 2022.
Thourani noted the significant uptick in patients seeking treatment with the Trilogy device. “Patients are starting to come out of the woodwork because people know that it’s there,” he said.
