Healthcare Industry News: transcatheter valve
News Release - November 2, 2010
JenaValve Technology Initiates Multicenter CE-Mark Study for Its Transapical TAVI SystemWILMINGTON, Del. and MUNICH--(Healthcare Sales & Marketing Network)-- JenaValve™ Technology, Inc., a medical device company specialized in developing transcatheter valve replacement products, announced today the start of its multicenter CE-mark study. The first two implantations of its transapical TAVI system were performed by Dr. med. Hendrik Treede at the Universitäres Herzzentrum Hamburg.
At the end of September 2010 JenaValve received approval from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) to conduct a multicentric pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. The CE-mark trial is designed as a prospective multicentric uncontrolled study in which up to 70 patients with severe symptomatic aortic valve stenosis will be enrolled. The primary endpoint of the trial is a 30-day mortality rate; secondary endpoints are procedural success, valve performance and safety.
The JenaValve transapical TAVI system is designed for the treatment of severe stenotic aortic valve disease in elderly high-risk patients, especially those unsuitable for conventional open heart surgery.
Prof. Dr. med. Friedrich-Wilhelm Mohr, Director of the Clinic for Cardiac Surgery, Heart Center Leipzig and Principal Investigator will lead the multicenter CE-mark study. According to Prof. Mohr, “European and US cardiac surgeons and cardiologists are following JenaValve with interest and have referred many elderly patients whom we have qualified. The study is important because, if approved, it may identify a new transapical TAVI system generation which promises precise implantation and ease-of-handling for physicians.”
Helmut J. Straubinger, CEO of JenaValve Technology, commented, “In the weeks ahead our resources will converge to ensure the support and success of the transapical CE-mark study. The development of our transfemoral TAVI system continues in parallel.” The company anticipates completion of patient enrollment in Q1 2011 and CE-mark approval in Q3 2011.
JenaValve completed patient enrollment of the First-in-Man study in April 2010. Initial results of the 30-day mortality as primary endpoint were presented at the TCT in Washington, D.C.
About JenaValve’s TAVI system
JenaValve has focused its product development on fundamental, patented, design features:
- Low profile prosthesis and stent design
- Feeler-guided positioning
- Unique JenaClip™ anchoring mechanism
- Repositionability and retrievability
- Enhanced radiopacity
About JenaValve Technology
JenaValve Technology is a medical device company focused on developing transcatheter valve implantation systems to treat patients suffering from aortic valve disease. The company has transcatheter aortic valve implantation (TAVI) systems for both transapical and transfemoral approaches to address the needs of the cardiac surgeon and cardiologist, respectively. JenaValve Technology GmbH is headquartered in Munich, Germany; its holding company is JenaValve Technology, Inc., Delaware, USA. Additional company information is available at www.jenavalve.de.
JenaValve and JenaClip are trademarks of JenaValve Technology GmbH. The JenaValve products are protected by pending and granted patent, design and utility model rights.
Source: JenaValve Technology
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