Boston Scientific Corp. wins Food & Drug Administration clearance and CE Mark approval in the European Union for its NC Quantum Apex PTCA dilation balloon catheter.
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.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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