First-in-Man Procedures Reported for JenaValve TAVI System

May 25, 2010—JenaValve Technology (Wilmington, DE) announced that it has completed first-in-man (FIM) procedures for its transapical transcatheter aortic valve implantation (TAVI) system. The procedures and implantations were performed in nine patients at the Heart Center in Leipzig, Germany. The company noted that the system's design features include unique positioning feelers, the JenaClip anchoring mechanism, and the low-profile JenaValve prosthesis.

The JenaValve system is being studied to assess its deliverability, repositioning, retrievability, and a new valve function for elderly, high-risk patients with severe aortic stenosis and comorbidities. Thirty-day mortality and procedural success rates were the primary endpoints of the FIM trial. Professor Friedrich-Wilhelm Mohr, MD, is principal investigator of the study.

"The JenaValve FIM is an exciting milestone in the development of TAVI systems,” commented Professor Mohr. “As long-term data are gathered and the next-generation technology is available, 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 company outlined the study's patient characteristics. Total enrollment involved 12 patients, with nine patients successfully treated, one procedural failure (type A dissection), and two aborted procedures because of unsuitable anatomy. After a catheter design modification, there was continuous procedural success. The mean age of the patients was 86.3 years, and all patients were women. The logistic EuroScore was 22.4%, and all patients were New York Heart Association classification 3. Annuli size ranged between 21 and 22.9 mm.

The company reported that the FIM results showed procedural success in nine patients, and all patients passed the 30-day survival endpoint. The procedures resulted in precise orientation, correct positioning, and placement of the prosthesis. Hemodynamic results demonstrated a mean gradient of 9 mm Hg and a peak gradient of 15 mm Hg after 30 days. There was no device migration or coronary obstruction, intraoperative death, myocardial infarction, stroke or death within 30 days, and there was also no postoperative conductivity impairment requiring a permanent pacemaker. Implantation time was consecutively reduced from 7 to 3 minutes. The investigators concluded that the JenaValve system design enables the physician to advance, rotate, reposition, or retract the device's feelers as necessary, leading to correct and precise placement of the prosthesis.

Professor Hans-Reiner Figulla, MD, observed that with all patients passing the 30-day follow-up visit, the FIM procedures demonstrated that the JenaValve prosthesis can be used for TAVI procedures. He noted that excellent hemodynamics confirmed the function of the JenaValve prostheses without the need for a pacemaker.