Medtronic PLC (NYSE:MDT) has publicized that it has obtained regulatory authorization for the self-expanding transcatheter Core Valve System in Japan. The self-expanding transcatheter will be used in patients suffering from severe aortic stenosis (AS).
The self-expanding transcatheter will be the best option for Aortic Stenosis patients, with core valve bringing new hope for patients who will go through surgery. The CoreValve system for Transcatheter aortic valve implantation (TAVI) was approved by the Japanese regulatory authorities.
The approval was based on strong data from the fundamental trials of CoreValve U.S. and those of Medtronic CoreValve Japan. The Japan trials were the first study to assess a self-expandable transcatheter valve in the Japanese patient populace.
Yoshiki Sawa, who is the M.D Professor in the cardiovascular surgery at Osaka University, said they were thrilled to offer new option to their patients. He said that the core valve system had revealed excellent clinical results.
Dr. Yoshiki said that Doctors in Japan should have sureness in making TAVI treatment judgments for patients. Especially those who stand a chance of benefiting from a less aggressive valve replacement process, with this proven self-expandable valve.
Information collected from the risky core value experiments in the U.S pivotal trials revealed the safety and effective nature of the core valve system. The system is characterized by a high survival rate and very few reports of valve leakage and strokes recorded.
The Medtronic Japan core valve trials confirmed the CoreValve’s performance as revealed in the U.S. Pivotal Trials. Within a period of half a year, 91.7% of the TAVI surgery via the femoral artery, trial patients in Japan reached the major endpoint of improvement.
Rhonda Robb, who is the vice president and general manager of the Heart Valve Therapies business, made a positive comment about the core valve system. She expressed Medtronic’s commitment towards introducing life-changing therapy to patients in Japan.
Overall the whole project has been a success and a key achievement in the medical field.