2014

JenaValve Announces First Implantations Of Transapical TAVI System In Canada Severely Calcified Aorta Disqualified Patients for Conventional Aortic Valve Replacement

WILMINGTON, Del. and MUNICH, Aug. 19, 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 two implantations of its second-generation transapical JenaValve TAVI system in Canada. These are also the first two implantations of the second-generation transapical JenaValve TAVI system outside of Europe.

The implantations were performed by John Webb, M.D., the Director of Interventional Cardiology at St. Paul's Hospital in Vancouver, and Jian Ye, M.D., Clinical Professor of Surgery and Director of Cardiac Surgery Research at St. Paul's Hospital in Vancouver. Hendrik Treede, M.D., Director Minimally Invasive Cardiac Surgery at the University Heart Center Hamburg, Germany, with his extensive experience in using the JenaValve system, supported both implantations.

Both patients, an 87- and a 71-year-old woman, were suffering from severe and symptomatic aortic stenosis and at high risk for aortic valve replacement surgery due to their advanced age and co-morbidities.

"The unique JenaValve transapical approach was the preferred TAVI for these patients and we believe the results are very promising," said Dr. Ye. "The JenaValve transapical TAVI system provides true anatomical positioning. The low profile of the prosthesis is especially suitable for patients with low lying coronary ostia. With the use of JenaValve's system, no rapid ventricular pacing is required during the valve implantation, which potentially reduces myocardial stress and ischemia, particularly in a patient with coronary artery disease and severe left ventricle dysfunction."

"We use the JenaValve transapical TAVI system on a very regular basis at the University Heart Center Hamburg for patients suffering from aortic valve stenosis who are at too high risk for conventional surgery. We have used the JenaValve in highly stenosed and calcified aortic valves as well as in pure aortic insufficiencies with very promising results," stated Dr. Treede.

Helmut J. Straubinger, CEO of JenaValve Technology, noted that the technology in the JenaValve TAVI system continues to prove its value in a wide variety of patients.

"Our physician partners and everyone at JenaValve continue to be encouraged by the results in challenging cases like these because they demonstrate the potential value of our technology to literally millions of patients around the world. Our second-generation device was designed to overcome the limitations of current first generation devices and we believe these cases again demonstrate that we have made important progress in that effort," Straubinger said. "Our current goal is to expand with our second-generation TAVI device worldwide, to bring a transfemoral and transaortic device to market in 2014, to offer physicians and patients a safe and efficient therapy option."  

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. med Dr. Hans R. Figulla and Markus Ferrari, M.D., Ph.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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