Boston Scientific (NYSE:BSX) landed regulatory wins in 3 major global markets for its OptiCross coronary imaging catheter, which the medical device giant touts as a higher-resolution device for tricky heart procedures.
The Natick, Mass.-based company landed European CE Mark and U.S. FDA clearance, and products are already hitting shelves in these 2 markets. Japan also granted its PMDA approval for the device, and product launch there is slated for next month.
OptiCross is a catheter that provides ultrasound imaging inside coronary arteries, designed to work alongside Boston Scientific’s iLab Imaging System.
OptiCross "represents the 1st of a series of related innovations that we expect to launch in the next 18 months," Isaac Zacharias, Boston Scientific VP, said in prepared remarks.
The company is also launching its Guidezilla catheter in the U.S. and E.U., despite the best efforts of rival Vascular Solutions (NSDQ:VASC), which has attempted to win a legal order to block the device.