Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

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Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad range of peripheral vascular applications. The product is the result of the company’s ongoing investment in a pipeline of highly differentiated whole-product solutions. Surmodics expects to make the product available for distribution in the coming months.

This new low-profile product combines our most advanced balloon technologies with Surmodics’ proprietary, low-friction, low-particulate Serene® hydrophilic coating for superb tracking, and unmatched lesion crossing performance, while delivering high pressures and a broad offering ranging from 2mm to 10mm diameter.

“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of differentiated products that are designed to advance the treatment of vascular disease,” said Gary Maharaj, President and CEO of Surmodics. “This regulatory milestone adds to the recent clearances of the Telemark™ .014” Support Microcatheter and the .014” BTK Balloon Dilatation Catheter.”

Surmodics’ whole-product solutions strategy leverages its comprehensive, vertically integrated design, development and high volume commercial production capabilities at its state-of-the-art facility in Ballinasloe, County Galway, Ireland. At this facility we control every step of the manufacturing process to produce the highest quality medical devices designed to address unmet clinical needs.

For Further Information

More on the peripheral vascular stent market in the U.S. can be found in a report series published by iData Research entitled the U.S. Market Report Suite for Peripheral Vascular Devices and Accessories. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.

Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about peripheral vascular device market data or procedure data, register online or email us at [email protected] for a U.S. Market Report Suite for Peripheral Vascular Devices and Accessories brochure and synopsis.

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