2014.05.26

Road to Commercialization : OZAKI VRecS™ ~Aortic Valve Reconstruction “AVRec”~

■What is Aortic Valve Reconstruction “AVRec”?
Aortic valve reconstruction is a new surgical technique that Professor Shigeyuki Ozaki has been devised at the 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 because of the nature of this new procedure in which original movement of the base of the valve (valve annulus) is maintained.

【Video 1】 Aortic valve reconstruction

【Video 2】 Movement of aortic valve

【Video 3】 Aortic valve area difference between prosthetic valve and aortic valve

■Introduction of Ozaki sizer & template “OZAKI VRecS™”
A sizer set (OZAKI VRec sizer ™ / OZAKI VRecS ™) has been designed to be able to measure the distance between commissuresof original valve. By the distance between the commissure, the size of a leaflet for each of three valves is determined. With nine sizers with different size, one template with the form of nine valves is included in one set, you can cut the pericardium as a valve with the appropriate size by using this template.

OZAKI_VRecS_1


■The road to Commercialization
7 years ago, Professor Shigeyuki Ozaki performed the world’s first AVRec for an aortic valve disease patient. This technic has attracted a lot of international attention with great advantage of high biocompatibility, less financial burden and QOL, and Professor Ozaki called “Super Doctor” is now conducting lectures and demonstrations of Ozaki method all over the world.

So far, Standard invasive procedure for aortic valve disease has been thoracotomy aortic valve “replacement” with using prosthetic valve like mechanical valve or biological valve, however, prosthetic valve is quite expensive and significant burden for national health care cost for contries. Furthermore, low durability of biological valve has been pointed out. In response, Ozaki method “AVRec” using autologous pericardium is considered to provide tremendous cost-benefit because of non-use of expensive prosthetic valve. Dr.Uchida, CEO of JOMDD and a cardiologist, who was highly impressed to this technic believes this technic is excellent asked professor Ozaki in 2012 to cooperate on a development for commercialization of OZAKI VRecS™ for establishing Ozaki method as “World standard” of AS(aortic stenosis) and AR(aortic regurgitation).

In the beginning, prototype of sizer set which is manufactured in a certain small factory had been used at a doctor’s discretion, however, JOMDs moved into action to develop sizer set in order to make necessary improvements in the product to match medical device regulation around the world so that sizer set can be commercialized officially. First, JOMDs applied the Fukushima Medical and Welfare Medical Device Development Operating Cost Subsidized project 2013 and was adopted as project name “Development and commercialization of a sizer and a template for assisting innovative aortic valvuloplasty.(*1) After that, the project went well and the product, OZAKI VRecSTM was approved in Japan by PMDA in 28th March, 2014 and in U.S. by FDA in 1st April, 2014 as classⅠ device.

JOMDs continues research and development in order to mass-produce and drives commercialization for the noble aim of spread this technic by getting approval of other countries around the world in 2014.

*1 Valvuloplasty was changed to valve reconstruction for the academic reason.