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."