JenaValve Announces First Implantations Of Transapical TAVI System In Argentina Company Continues to Expand Commercialization of Second-Generation Device Worldwide

WILMINGTON, Del. and MUNICH, Sept. 4, 2013 /PRNewswire/ -- JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced today that it has successfully completed the first three implantations of its second-generation transapical JenaValve TAVI system in Argentina.

The implantations were performed by interventional radiologist Esteban Mendaro, M.D., interventional cardiologists Pablo Kantor, M.D. and Fabrizio Monacci, M.D. and surgeon Fabian Donnini, M.D., all of Sanatorio de la Providencia in Buenos Aires. Prof. Markus Ferrari, M.D., Director of the Department of Cardiology at the Dr. Horst Schmidt Kliniken in Wiesbaden, Germany, and co-inventor of the JenaValve TAVI System, served as proctor to support the implantations.

"JenaValve's second-generation TAVI system was particularly suitable for these patients," said Dr. Kantor. "The low profile of the prosthesis in the JenaValve system ensures open flow to the coronaries after implantation. Also, rapid pacing is not required during prosthesis positioning and release, and hemodynamic flow is maintained during prosthesis placement reducing intraoperative trauma."

"The unique JenaValve design provides advantages over the 1st generation TAVI device," said Dr. Monacci. "The clipping mechanism that anchors the JenaValve provides active fixation and resistance to valve migration and makes the valve usable independent from the calcification level of the native valve."

"The second-generation TAVI system was designed with the physicians and patients in mind," said Dr. Mendaro. "The self-expanding stent has three 'feelers,' which enable a more tactile placement and help to accurately position the prosthesis anatomically correct."

Helmut J. Straubinger, CEO of JenaValve Technology, noted that the Company continues to find a need for the JenaValve TAVI system for an expanding patient population throughout the world.

"The value of our technology is unlimited by geography, as the testimony from our physician partners in Argentina demonstrates," Straubinger said. "Our goal has always been to expand our second-generation TAVI device worldwide and we are especially proud of having the first implantation in Latin America. The use of the transapical access in Argentina is still in its infancy and we believe that the unique and beneficial design of our 2nd generation transapical TAVI system offers physicians and patients an additional safe and efficient treatment opportunity."

About TAVI

Transcatheter aortic valve implantation (TAVI) systems have already yielded nearly $1 billion in revenues worldwide and the market is expected to grow to over $3 billion in 20161. Clinicians are now focused increasingly on TAVI technical and procedural refinements and advancements found in second-generation products such as JenaValve's that address and resolve issues including ease of implantation, the need for post-procedure pacemaker implantation and post-implant paravalvular leakage.

About the JenaValve™ TAVI System

The JenaValve is a true second-generation catheter-based aortic valve implantation system engineered and manufactured to the highest quality standards. The JenaValve transapical TAVI system is currently being sold in Europe. The Company's transfemoral TAVI system is expected to enter into clinical study later in 2013 and is anticipated to be available for sale in 2014.

  • The JenaValve prosthesis consists of a natural aortic porcine root bioprosthesis fitted with an outer porcine pericardial patch, a so-called skirt, before being sewn onto a Nitinol self-expanding stent. The high-quality bioprosthesis is durable, ensuring long-term aortic valve function.
  • JenaValve's unique "3-feeler element" allows the clinician to accurately position the prosthesis in the anatomically correct position during implantation thus ensuring a precise sub-coronary alignment within the patient's native valve.
  • JenaClip™ anchoring and clipping mechanism allows the patient's native valve leaflets to be clipped onto the valve enabling the JenaValve to be firmly anchored in the correct anatomical position and provide active fixation and resistance to migration.
  • The JenaValve implantation is conducted on the beating heart. Hemodynamic flow is maintained without cardiac arrest and rapid pacing is not required during the procedure. The low profile of the stent prosthesis ensures open flow to the coronaries after the implantation. The JenaValve is available in three sizes, 23mm, 25mm and 27mm, covering aortic valve annuli from 21mm to 27mm.
  • JenaValve is retrievable and repositionable thereby contributing to a successful procedure and confidence of the clinician.

About JenaValve Technology, Inc.

JenaValve Technology, Inc., a U.S. corporation with primary operations in Munich, Germany, develops, manufactures and markets transcatheter aortic valve implantation (TAVI) systems to treat patients suffering from aortic valve disease. JenaValve was founded in 2006 by cardiologists and inventors Prof. Hans R. Figulla, M.D. and Prof. Markus Ferrari, M.D.. The Company's transapical aortic valve system is CE marked and currently marketed in Europe and other markets worldwide. JenaValve is backed by world-class U.S., European and Asian investors. Additional information is available at www.jenavalve.com  

European Contact: JenaValve Technology Inc. and JenaValve Technology, GmbH, Munich (Germany) +49 895 527 9080 or info@jenavalve.de

U.S. Contact: Matt Clawson, Allen & Caron Inc. +1-949 474 4300 or Matt@allencaron.com

1)     Goldman Sachs Global Investment Research

SOURCE JenaValve Technology, Inc.



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