Sam Brusco, Associate Editor06.28.22
JenaValve, a maker of differentiated transcatheter aortic valve replacement (TAVR) systems, released positive results from the first European Trilogy heart valve system commercial implants for high-risk severe, symptomatic aortic stenosis (AS) or aortic regurgitation (AR) patients.
The data was presented at this year’s EuroPCR.
“We are very pleased with the robust clinical outcomes experienced by our commercial European patients being treated for both AR and AS,” John Kilcoyne, JenaValve’s CEO told the press. “The early results demonstrate that our Trilogy Heart Valve System can be safe and effective for patients suffering from AR and AS outside a clinical trial. These results mark another milestone in JenaValve’s journey to becoming the standard of care for the treatment of AR, as these were the first implants of their kind in the real world.”
The first 28 commercial Trilogy implants across six high-volume German centers yielded 100% technical success, no conversions to open surgery, no new permanent pacemakers, and one patient death that was not device-related. Post-op, 86% of patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.
“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” said Matti Adam, MD. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”
Data was further presented on 45 AR patients from the same six German heart centers. Technical success was achieved in all patients. There were no conversions to open surgery, stroke, or death. Post-op, 92% of patients had none or trace PVL and nine required a new pacemaker.
“Before Trilogy’s CE Mark approval, TAVR for AR was performed off-label using devices designed for aortic stenosis—which posed procedural challenges with poorer outcomes,” said Alexander R. Tamm, MD. “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the hemodynamics are the best in class.”
The data was presented at this year’s EuroPCR.
“We are very pleased with the robust clinical outcomes experienced by our commercial European patients being treated for both AR and AS,” John Kilcoyne, JenaValve’s CEO told the press. “The early results demonstrate that our Trilogy Heart Valve System can be safe and effective for patients suffering from AR and AS outside a clinical trial. These results mark another milestone in JenaValve’s journey to becoming the standard of care for the treatment of AR, as these were the first implants of their kind in the real world.”
The first 28 commercial Trilogy implants across six high-volume German centers yielded 100% technical success, no conversions to open surgery, no new permanent pacemakers, and one patient death that was not device-related. Post-op, 86% of patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.
“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” said Matti Adam, MD. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”
Data was further presented on 45 AR patients from the same six German heart centers. Technical success was achieved in all patients. There were no conversions to open surgery, stroke, or death. Post-op, 92% of patients had none or trace PVL and nine required a new pacemaker.
“Before Trilogy’s CE Mark approval, TAVR for AR was performed off-label using devices designed for aortic stenosis—which posed procedural challenges with poorer outcomes,” said Alexander R. Tamm, MD. “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the hemodynamics are the best in class.”
