Wilmington, Delaware and Munich, Germany – June 4th, 2014 – 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 implantation of its second-generation transapical JenaValve TAVI system in Sweden.
The implantation was performed by cardiac surgeon Dr. Vilyam Melki from Uppsala University Hospital, Uppsala, Sweden. Prof. Hans R. Figulla, M.D., Director of the Clinic for Internal Medicine and Cardiology in Jena, Germany, served as proctor to support the implantation.
“We treated one patient suffering from aortic valve stenosis that was declined for open heart surgery due to comorbidity. The patient had a severely calcified valve with an unsymmetrical calcium distribution”, Dr. Melki declared. “We have chosen the transapical JenaValve TAVI System because we think that its unique features are beneficial for this kind of patients. The JenaValve TAVI System consists of a self-expanding Nitinol stent with three so-called feelers that “guide” the prosthesis into the anatomically correct position. Furthermore, the prosthesis is fixed onto the native valve leaflets with a clipping mechanism, similar to a paper-clip. The advantage of this mechanism is that it works independently of the calcification level of the native valve and does not put stress on annulus and aorta and thus reduces the risk for any dissection or calcium migration.”
Dr. Melki added: “The first case showed that the JenaValve was the right decision: the prosthesis was introduced and delivered properly and the clinical outcome proves the concept. The patient had well improved haemodynamics, no paravalvular leakage (PVL) and no signs of coronary obstruction, AV-block or neurological changes”
The first JenaValve implantation in Sweden once more confirms the company´s strategy to further expand its business across Europe, Helmut J. Straubinger, CEO of JenaValve Technology, stated.
“We see a continuous expansion of our unique TAVI system because of its features and the resulting patient benefits. We have proven the advantages in a wide range of treatments worldwide, underlined by recently published clinical data of our post-market registry JUPITER. We are really looking forward to offer our technology to physicians and patients in Sweden.”