Opsens has obtained Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its OptoWire II to market it in the country.
The company has upgraded its original OptoWire by adding a hydrophilic coating to improve navigation in the most tortuous and calcified vessels. It will help cardiologists to measure fractional flow reserve (FFR).
The firm has developed FFR products to enhance the diagnostic and guide treatment in patients with coronary heart disease.
The company has recently received CE mark approval to market OptoWire II in Europe, while it is soon expected to receive approval in the US.
OptoWire, which is a nitinol-based optical guidewire, offers intra-coronary blood pressure measurements with patented optical pressure guidewire technologies.
Opsens medical devices vice-president Claude Belleville said: "OptoWire II makes assessment of complex coronary blockages easier and will help cardiologists decide whether patients require intervention or not.
"This ease of use could help promote the use of FFR further and widen access to this diagnostic method that improves patient outcomes and helps avoid unnecessary medical procedures."
Opsens CEO and president Louis Laflamme said: "Our Japanese partner, a player in interventional cardiology in Japan , is directing a well-organized distribution network that helped grow Opsens’ FFR sales in the first quarter of fiscal 2016."