News | June 03, 2014

JenaValve TAVI System Primary Endpoint Data Presented at EuroPCR

Data on real-world patient population shows new Cathlete Plus delivery system provides improved ease-of-use

June 3, 2014 — JenaValve Technology Inc., a privately held, venture-backed developer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, 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 second-generation transapical JenaValve TAVI system in elderly high-risk patients. All major VARC I events were adjudicated by an independent medical reviewer with 100 percent SAE event monitoring.

“The JUPITER registry is based on a high-risk patient population with severe degenerative aortic valve disease,” said Olaf Wendler, M.D., consultant cardiothoracic surgeon at King’s College Hospital London and principal investigator for the registry. “The positive outcomes and low adverse event rates confirm the benefit of treating patients suffering from aortic stenosis with the JenaValve TAVI system.”

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. 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, and severe PVL did not occur in any of the discharged patients.

“The low PVL rates are particularly promising as post-implantation 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,” Wendler added.

Dr. Hendrik Treede, M.D., senior consultant at the University Heart Center in Hamburg and co-investigator for the JUPITER registry, said, “More than 25 percent 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 shows a procedural success of almost 98 percent and an all-cause mortality of 8.5 percent.”

“We are 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,” said Helmut J. Straubinger, CEO of JenaValve Technology.

For more information: www.jenavalve.com

Related Content

Edwards Recalls Sapien 3 Ultra Delivery System Due to Burst Balloons During Surgery
News | Heart Valve Technology | August 22, 2019
Edwards Lifesciences is recalling the Sapien 3 Ultra delivery system after receiving reports of burst balloons during...
FDA Approves Sapien 3, CoreValve Evolut TAVR Valves for Low-risk Patients

Left, an illustration of the beginning of deployment for a CoreValve Evolut self-expanding transcatheter aortic replacement (TAVR) valve. Right, an illustration of the final balloon expansion of an Edwards Lifesciences Sapien 3 TAVR valve. Both valves received simultaneous FDA clearance for use in low-risk surgical patients. Clearing this last hurdle now allows wide-spread use of minimally invasive TAVR in all patients who otherwise would need an open-heart surgical valve replacement. 

Feature | Heart Valve Technology | August 16, 2019 | Jeff Zagoudis, Associate Editor, and Dave Fornell, Editor
In one coordinated move, the U.S. Food and Drug Administration (FDA) opened transcatheter aortic valve replacement (...
Abbott Receives U.S. Approval of Next-generation MitraClip G4
Technology | Heart Valve Technology | July 17, 2019
Abbott has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip heart valve repair...
Neovasc Tiara, Reducer Transcatheter Devices Featured at CSI Frankfurt 2019 Conference
News | Heart Valve Technology | July 09, 2019
Neovasc Inc. announced that its Tiara transcatheter mitral valve replacement (TMVR) device and its Neovasc Reducer...
Study Shows Inducing a Heart Attack Helps Valve Patients. This image shows a left-ventricular outflow tract (LVOT) obstructed by an Edwards Sapien TAVR valve used for a valve-in-valve procedure. The arrow points to the small, crescent shaped dark area of the neo-LVOT, which did not allow enough blood to flow from the left ventricle into the aorta and the rest of the body. To prevent this issue, the procedure used by Henry Ford ablates some of the tissue in the septum to allow for a larger LVOT area.

This image shows a left-ventricular outflow tract (LVOT) obstructed by an Edwards Sapien TAVR valve used for a valve-in-valve procedure. The arrow points to the small, crescent shaped dark area of the neo-LVOT, which did not allow enough blood to flow from the left ventricle into the aorta and the rest of the body. To prevent this issue, the procedure used by Henry Ford ablates (kills) some of the tissue in the cardiac septum to allow these valves to fit better and allow for an enlarged neo-LVOT for patients who otherwise could not receive this therapy. 

News | Heart Valve Technology | July 03, 2019
A study of a procedure developed at Henry Ford Health System shows inducing a heart attack in patients with heart...
CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement
Feature | Heart Valve Technology | June 24, 2019
The Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to update the national coverage...
Abbott Tricuspid Valve Repair System Reduces Tricuspid Regurgitation at 30 Days
News | Heart Valve Technology | June 11, 2019
June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE...
DSM and SAT Partnering to Develop Next-Generation, Cost-Effective Heart Valve
News | Heart Valve Technology | June 04, 2019
Royal DSM recently announced a collaboration with Strait Access Technologies (SAT), to develop the world’s first...

The MitraClip is one example of a transcatheter mitral valve repair or replacement (TMVR) device used in the structural heart repair program at Henry Ford Hospital.

Podcast | Heart Valve Technology | May 31, 2019
Marvin Eng, M.D., structural fellowship director at Henry Ford Health System, and William O'Neill, M.D., director of
Overlay Init