Therapy Areas: Devices
Surmodics Receives FDA 510(k) and CE Mark Clearance for .014" PTA Balloon Catheter
19 September 2017 - - Eden Prairie, Minnesota-based medical device and in vitro diagnostic technologies provider Surmodics, Inc. (NASDAQ: SRDX) has received US Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014" low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, the company said.
Designed for peripheral angioplasty procedures,, the company is making this product available for distribution in the coming months.
Surmodics .014" PTA balloon catheter leverages the company's proprietary Serenehydrophilic coating, unmatched for low friction and particulates. 
Its proprietary balloon and catheter technology, combined with Surmodics' advanced processes, ensures ultra-low tip entry and crossing profile with smooth transitions, to achieve best-in-class product performance.
With a complete suite of in-house capabilities at its state-of-the-art facility in Ballinasloe, Ireland, Surmodics controls every step of the manufacturing process to produce high-quality, reliable balloon catheters under rigorous testing.
Surmodics develops surface modification technologies for intravascular medical devices and provides chemical components for in vitro diagnostic (IVD) tests and microarrays.
Following acquisitions of Creagh Medical and NorMedix, the company is expanding to offer total intravascular product solutions to its medical device customers.
The company's mission is to improve the detection and treatment of disease.
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