Japan Lifeline Co., Ltd. announced that it has signed an exclusive 10-year distribution agreement with Meril Life Sciences Pvt. Ltd. This agreement, signed on October 27, 2023, allows the Company to sell the transcatheter heart valve "Myval Octacor" used in Transcatheter Aortic Valve Replacement /Implantation (TAVR /TAVI) procedures in Japan following its approval of the Ministry of Health, Labor and Welfare. The Company is planning to newly enter the TAVR /TAVI market as part of its cardiovascular business expansion strategy.

The Company expects to launch the product within a few years. TAVR /TAV I is a treatment that replaces a malfunctioning heart valve caused by aortic stenosis with a biological valve through a catheter based interventional procedure. This treatment received the reimbursement coverage in Japan in 2013.

While open-heart surgery (SAVR) was the common treatment before, TAVR /TAVR /TAVI has quickly become widespread because it's less physically invasive. In 2021, about 12,000 TAVR/TAVI procedures were performed, and the Company expects this number to increase by 4-5% annually. In TAVR/TAV I, it is crucial to place the valve in the correct position to avoid serious complications.

Meril's Myval Octacor THV is a next generation, balloon-expandable transcatheter heart valve that has various features to ensure accurate placement. It offers a wider range of sizes than competitors, allowing doctors to choose a size that best fits the patient's annulus diameter. The "octagonal cell structure" helps reduce positional displacement during the procedure.

Japan Lifeline used to sell heart valves for surgical treatment (SAVR), but the Company withdrew from the business area in 2019 due to the rapid spread of TAVR /TAVi. Japan Lifeline plans to apply for regulatory approval for Myval Octacor TH VV as a marketing authorization holder, and prepare for a launch within a few years. Japan Lifeline's spokesperson says that they are eager to expand their product portfolio in the TAVR /TAVI field with the Meril's distinctive product, and work to realize a healthier society through the latest and most optimal medical device technologies.