JenaValve Technology has announced the results of the JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere AoRtic Stenosis (JUPITER) Registry at EuroPCR in Paris.
JUPITER is a post-market registry designed to evaluate acute, 30-day and long-term safety and effectiveness of the 2nd generation transapical JenaValve TAVI system in elderly high-risk patients. All major VARC I events were adjudicated by an independent medical reviewer with 100% SAE event monitoring.
In the 30-day results, JenaValve demonstrated good procedural success rates and excellent clinical outcomes in a real world patient population. In 180 patients with a mean logistic EuroSCORE of 22.3%, the procedural success rate was 95%.
Major adverse events such as major stroke (1.1%) were very low and represent the safety of the JenaValve TAVI system. Excellent hemodynamics and very low paravalvular leakage (PVL) confirm the advantages of the system; 99.4% of the patients were discharged with PVL that ranged from non-existent to mild, severe PVL did not occur in any of the discharged patients.
JenaValve Technology CEO Helmut Straubinger noted that the company is very encouraged by the excellent patient outcomes and positive physician feedback related to the new Cathlete Plus delivery system.
"The JUPITER Registry data continue to demonstrate that the unique advantages of the JenaValve system result in beneficial clinical outcomes for patients suffering from aortic valve calcification," Straubinger added.