Primary Endpoint Data From Postmarket JUPITER Registry Presented for JenaValve TAVI System

May 22, 2014—JenaValve Technology, Inc. announced that results from the JUPITER (JenaValve Evaluation of Long-Term Performance and Safety in Patients With Severe Aortic Stenosis Registry) trial were presented at the EuroPCR 2014 congress in Paris, France. Prof. Olaf Wendler, MD, serves as principal investigator for the registry.

JUPITER is a postmarket 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 for the treatment of aortic valve disease in elderly high-risk patients. All major Valve Academic Research Consortium I events were adjudicated by an independent medical reviewer with 100% serious adverse event monitoring.

In JenaValve’s press release, Prof. Wendler commented, “The JUPITER registry is based on a high-risk patient population with severe degenerative aortic valve disease. The positive outcomes and low adverse event rates confirm the benefit of treating patients suffering from aortic stenosis with the JenaValve TAVI system.” Prof. Wendler is Consultant Cardiothoracic Surgeon at King’s College Hospital London in the United Kingdom.

According to the company, JenaValve demonstrated good procedural success rates and excellent clinical outcomes at 30 days 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 nonexistent to mild; severe PVL did not occur in any of the discharged patients.

Prof. Wendler added, “The low PVL rates are particularly promising, as postimplantation leakage around the valve is a common concern and a dangerous side effect often seen in patients with severe calcification of the valve or valve leaflets. JenaValve’s technology enables precise anatomically correct positioning and more secure attachment to even highly calcified anatomies, resulting in one of the lowest PVL rates seen in other published registry data.”

Also in the JenaValve press release, Prof. Dr. Hendrik Treede, MD, coinvestigator for the JUPITER registry and Senior Consultant at the University Heart Center in Hamburg, Germany, stated, “More than 25% of the patients included in the registry have been treated using a new proprietary delivery system called Cathlete Plus. Cathlete Plus received CE Mark in September 2013, and we have been one of the first centers using it. The functional improvements compared to the Cathlete delivery system were obvious already in the first case: its intuitive and reliable design has improved the ease of use and gives you control over delivery and placement of the prosthesis. The registry confirms now that these improvements also result in outcomes even better than the legacy delivery system. The JUPITER data show a procedural success of almost 98% and an all-cause mortality of 8.5%.”

The company advised that the JenaValve transapical TAVI system is currently available in Europe and other international markets. The JenaValve is available in three sizes, 23, 25, and 27 mm, covering aortic valve annuli from 21 to 27 mm. The company’s transfemoral TAVI system entered into a first-in-man clinical study at the end of 2013 and is anticipated to be commercially available for sale in 2015.