JenaValve Is a Growing Force to be Reckoned with in TAVR

It would be a big mistake to leave JenaValve out of the transcatheter aortic valve replacement (TAVR) market conversation. The Munich, Germany-based company has been biding its time and reaching milestones, in the hopes of obtaining some serious market share in the TAVR space. The small company's latest achievement is successfull enrollment in the CE mark study of the next generation of JenaValve Pericardial TAVR system. “It’s very tricky to develop a TAVR system because it can take several iterations before you can get it right,” Victoria Carr-Brendel, JenaValve CEO, told MD+DI. “We think we have achieved in just a couple of generations of this transfemoral system, a viable device that actually gets it right.” The company will submit for CE mark sometime in the second quarter and could gain approval in Europe in the third quarter of this year. “Within a couple of quarters, we’re actually hoping to perform a limited market launch in specific regions in Europe and CE mark compatible countries,” she said. However, plans to come to the U.S. will take a bit longer. In December, JenaValve approached FDA and received approval for a pivotal protocol to perform an aortic stenosis pivotal trial of the TAVR device. “The FDA has been very collaborative and approved what we think is a very innovative protocol design that would enable us to probably get through the trial follow up and submission in a three-year-timeline,” she said.  She noted that the company ha...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Implants Source Type: news