Surmodics, Inc. (NASDAQ: SRDX), 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.
The company reports their 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.
Gary Maharaj, President and CEO of Surmodics. said, “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.” Maharaj went on to say, “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.