TriReme Medical has secured Shonin approval for its Glider PTCA catheter, through its Japanese partner Century Medical (CMI), allowing the company to distribute the product in Japan.
The device, which improves myocardial perfusion in the body by treating the stenotic portion of coronary arteries or bypass grafts, will help physicians treat highly challenging cases, such as bifurcations and highly stenosed lesions, according to TriReme.
Shonin is a pre-requisite for any foreign company looking to bring a medical device product in to the Japanese market, and is issued under Pharmaceutical Affairs Law (PAL) of Japan, which covers regulations on pharmaceuticals, medical devices and cosmetics.
TriReme CEO and president Dr Eitan Konstantino said the company is proud to obtain approval and is looking forward to working with CMI on the distribution of catheter.
"This milestone represents yet another concrete step in our strategic focus on the important Asian markets," Konstantino said.
TriReme plans to introduce several other products into the region through its partnership with CMI.
CMI president and CEO Akira Hoshino said; "Japanese cardiologists are well known for treating the most complex vascular disease".
In March 2013, TriReme had signed a comprehensive agreement with Weihai Weigao Medical Devices of China, under which Weigao will distribute TriReme's products directly to hospitals in the People's Republic of China.