First Results of JUPITER on Long-Term Performance, Safety of the Transapical TAVI JenaValve
June 21, 2013 — JenaValve Technology Inc. announced its first interim 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 second generation transapical JenaValve TAVI system in 180 elderly high-risk patients. The consecutive enrollment of the patients in the clinical trial ensures that the patient population represents a real world clinical use of the device. All serious adverse events were source data verified. Major adverse events were adjudicated by an independent medical reviewer.
Since the first commercial implantation of TAVI systems in 2006, efforts of the manufacturers and physicians have been to further improve the handling of the devices and the clinical outcome. Device and procedural-related results including procedural success, stroke rates and paravalular leakage are important drivers for patient safety.
With the 30-day results of the first half of the patients enrolled in the JUPITER registry, JenaValve demonstrated high procedural success rates and excellent clinical outcomes in a real world patient population with its transapical TAVI system. In 88 patients with a mean logistic EuroSCORE of 24.9 percent, the procedural success rate was 95.5 percent. Major adverse events such as major stroke (0 percent) or spontaneous myocardial infarction (1.3 percent) 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; 97.6 percent of the patients had a PVL <= mild, severe PVL did not occur (0.0 percent).
The data was presented by Stephan Ensminger, M.D., Ph.D., from the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, on behalf of the registry investigators. "The JUPITER registry confirms the excellent performance and safety of this 2nd generation TAVI system in a real-world clinical use," said Ensminger.
"The very good stroke and PVL data is especially impressive. With no PVL > mild and only 2.3 percent of moderate PVL, the JenaValve TAVI system shows one of the lowest PVL rates reported in a TAVI registry," added Helmut J. Straubinger, CEO of JenaValve Technology.
For more information: www.jenavalve.com