TOKYO, Japan, January, 2018 — Japanese Organization for Medical Device Development, Inc. (JOMDD; CEO: Takahiro Uchida, Tokyo, JAPAN), proudly announced today they have entered into a distribution agreement with Terumo Cardiovascular Group for JOMDD’s product, the Ozaki AVNeo™ Sizer System. With this agreement, JOMDD will be able to further accelerate the adoption of the innovative aortic valve neo-cuspidization surgical technique, which utilizes the Ozaki AVNeo Sizer System.
Aortic valve neo-cuspidization is a surgical technique for aortic insufficiency and aortic stenosis. Unlike the conventional valve replacement of implanting a prosthetic valve, this surgery is to treat the aortic valve by using patient’s own pericardium. The Ozaki AVNeo™ Sizer System plays an important role in this new surgery by allowing cardiovascular surgeons to measure the size and shape of the natural aortic valve commissures to determine the appropriate size of the replacement heart valve leaflets for cardiac valve reconstruction. It also provides consistency and efficacy to perform this surgery.
Terumo, with its worldwide team of sales and marketing professionals specializing in the cardiovascular arena, will lead the marketing activities for the Ozaki AVNeo Sizer System in the U.S. and Europe. By partnering with Terumo, JOMDD will be able to provide more sophisticated customer support and insightful advice to customers.
JOMDD will continue exploring worldwide opportunities by introducing this innovative surgical technique with the Ozaki AVNeo™ Sizer System as a potential de-facto standard to treat patients with aortic stenosis and insufficiency.
Aortic valve neo-cuspidization was started by Professor Shigeyuki Ozaki at the Cardiovascular Surgery Department of Toho University, Ohashi Medical Center (Tokyo, Japan). According to Professor Ozaki, “The surgery does not require anti-coagulant therapy (such as warfarin) needed for post mechanical valve replacement surgery. And as compared with the biological valve, it is possible to achieve the excellent long-term results because the surgery preserves the physiological motion of the base of aortic root.”
To learn more about the aortic valve neo-cuspidization operative procedure, ※please click below for the detailed content. (Note that this includes the actual videos and images at the time of surgery.)
Since May, 2014, JOMDD has successfully promoted a new surgical technique of aortic valve neo-cuspidization using a reusable sizing apparatus, the OZAKI VRec Sizer™/OZAKI VRecS™ worldwide. Recently, JOMDD has launched a single-use version of the sizing apparatus, the Ozaki AVNeo™ Sizer System, which solves the handling issue of sterilization of the reusable model. The Ozaki AVNeo™ Sizer System has already obtained a regulatory clearance in the U.S., EU, and Japan. JOMDD will continue contribution to health care society with deepened knowledge and wide range of expertise while accomplishing our mission of “Thriving Global Healthcare Society with Innovative Technology From Japan.”