JenaValve Technology Announces Results From Jupiter Registry

JenaValve Technology has announced the results of the JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere AoRtic Stenosis (JUPITER) Registry.

JUPITER is a post-market registry designed to evaluate acute, 30-day and long-term safety and effectiveness of the second-generation transapical JenaValve transcatheter aortic valve implantation (TAVI) system in elderly high-risk patients. All major VARC I (Valve Academic Research Consortium) events were adjudicated by an independent medical reviewer with 100 percent 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 percent, the procedural success rate was 95 percent.

Major adverse events such as major stroke (1.1 percent) were very low and represent the safety of the JenaValve TAVI system, according to the company. Excellent hemodynamics and very low paravalvular leakage (PVL) confirm the advantages of the system; 99.4 percent 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 said the company is encouraged by the patient outcomes and positive physician feedback related to its 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 said.