2014.05.26

JOMDD started selling a sizer set in the United States and in Japan.

We are honored to announce that we have started selling a sizer set, which is to be used for aortic valve reconstruction, in the United States and in Japan.

■ A new choice for the surgical treatment of aortic valve disease
Aortic valve reconstruction is a new surgical technique for aortic regurgitation and aortic stenosis. Unlike the conventional valve replacement of implanting a prosthetic valve, this surgery is to treat aortic valve by using patient’s own pericardium. Our new device will serve an important role during this new surgery. The device that we are developing determines the size and shape of the valve to rebuild. The device allows to perform surgery smoothly.

■ Aortic valve reconstruction (valve plasty) surgery
Aortic valve reconstruction is a new surgical technique that Professor Shigeyuki Ozaki has been devised at Cardiovascular Surgery department of Toho University, Ohashi Medical Center. Unlike the conventional valve replacement of implanting a prosthetic valve, this surgery uses the patient’s own pericardium. According to Professor Ozaki, “it does not require anti-coagulant therapy (such as warfarin) for post mechanical valve replacement surgery, and as compared with the biological valve, it is possible to achieve the excellent long-term results owing to the low-impact physiological move of the base of the valve (valve annulus).

※ Please click here for the detailed content of the operative procedure. (Please note that this includes the actual videos and images at the time of surgery.)
 http://www.lab.toho-u.ac.jp/med/ohashi/cvs/treatment/aortic_valvular/self-pericardial_sac.html

■ A sizer set (OZAKI VRec sizer ™ / OZAKI VRecS ™)
A sizer set (OZAKI VRec sizer ™ / OZAKI VRecS ™) has been designed to be able to measure the seam (commissure) between the original valves. By the distance between the commissure, the size of the valve to rebuild is determined. With nine sizers, one template with the form of nine valves are included in one set, you can cut the pericardium as a valve with the appropriate size by using this template.

※ Please click here for the details on how to use the sizer set. (Please note that this includes the actual videos and images at the time of surgery.)
 https://www.youtube.com/watch?v=2Zy3XD8Jhyw
 (18-37 seconds using a valve leaflet sizer. 38-52 seconds: using the template.)

We completed this product as a more secured one with biologically fit, based on those devised by Professor Ozaki. We received a market notification for this product on March 28th from Pharmaceuticals and Medical Devices Agency for (aka PMDA), and April 1st from U.S. Food and Drug Administration for (FDA).
※1 Class I medical devices can be sold with a market notification both in Japan and the United States.