JenaValve™ Technology, Inc., a medical device company specializing in transcatheter valve implantation systems, has announced completion of its first-in-man procedures for its transapical transcatheter aortic valve implantation (TAVI) system. The procedures and implantations were uccessfully performed in nine patients in Leipzig, Germany.
The goals of the study were to assess: (1) the deliverability of the prosthesis, (2) repositioning and retrieveability, and (3) new valve function in elderly, high-risk patients with severe aortic stenosis and co-morbidities. Thirty-day mortality and procedural success were the primary endpoints of the trial.
Dr. Friedrich-Wilhelm Mohr, Director of the Clinic for Cardiac Surgery, Heart Center Leipzig, and Principal Investigator, affirmed, “We expect that the transcatheter approach will replace invasive surgical treatment in many selective cases and become an alternative for high-risk patients that promises faster recovery and enhanced quality of life.”
The final results showed no device migration or coronary obstruction, no intraoperative death, no myocardial infarction, stroke or death within 30 days, no post-operative conductivity impairment requiring a permanent pacemaker, and implantation time was consecutively reduced from seven to three minutes.
The JenaValve system design enables the physician to advance, rotate, reposition or retract feelers as necessary, leading to a more correct and precise placement of the prosthesis in treating aortic valve disease. The JenaValve TAVI system provides three fundamental, patented, design features that include unique positioning feelers, the JenaClip™ anchoring mechanism and a low-profile JenaValve prosthesis.