Boston Scientific Corp. (NYSE:BSX) garnered both a CE Mark and Food & Drug Administration pre-market approval for its NC Quantum Apex PTCA dilation balloon catheter.
The post-dilation device is designed to optimize coronary stent deployment; according to the company’s POSTIT study, the device improves the accuracy of stent deployment compared with a stent delivery balloon alone.
Boston Scientific plans to begin marketing the product in Europe this week and in the U.S. next month. The FDA granted a PMA for the device April 16 for percutaneous transluminal coronary angioplasty.