Coronary imaging developer Infraredx has signed an exclusive five-year agreement with Nipro for the distribution of its TVC intravascular imaging system in Japan.
Under the terms of the agreement, Nipro will be responsible for obtaining marketing authorization for the TVC imaging system and catheter with the Pharmaceuticals and Medical Device Agency of the Japanese Ministry of Health, Labor, and Welfare. Nipro plans to file for regulatory approval this summer, Infraredx said.
After Shonin (clearance) is received, Nipro will be responsible for all marketing, sales, training, and service within Japan. Under the terms of the agreement, Infraredx will receive a minimum of $50 million in revenue. The companies expect to launch the product in Japan in 2013.
Used for vessel characterization of coronary artery disease, the TVC imaging system integrates near-infrared spectroscopy, lipid core plaque detection, and intravascular ultrasound (IVUS) imaging technology to assess vessel composition and structure, according to the company.
