Surmodics' 0.014-Inch Low-Profile PTA Balloon Dilation Catheter Receives FDA Clearance and CE Mark Approval


September 18, 2017—Surmodics, Inc. announced that it has received US Food and Drug Administration 510(k) clearance and European CE Mark approval for its 0.014-inch low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, which is designed for peripheral procedures. The device will be available for distribution in the coming months.

According to Surmodics, the 0.014-inch PTA balloon catheter incorporates the company’s Serene hydrophilic coating for low friction and particulates, thereby enhancing deliverability and lesion crossing. The device also features ultra-low tip entry and a crossing profile with smooth transitions.

Data from the early feasibility study of the company's SurVeil drug-coated balloon platform were recently presented at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.


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