EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Telemark™ .014” coronary and peripheral support microcatheter. The Company is making this product available for U.S. distribution in the coming months.
The Telemark support microcatheter offers superior crossability for complex coronary and peripheral lesions. The microcatheter combines Surmodics’ Xtreme™ composite shaft technology with a high-performance Pristyne™ hydrophilic coating that together provide exceptional deliverability, kink resistance and lesion crossing. Surmodics’ Pristyne hydrophilic coating offers best-in-class lubricity and low particulates. The Telemark microcatheter’s tapered profile design has an outer diameter ranging from 2.6 Fr to 1.4 Fr for effective penetration of tough, calcified lesions.
“This is another example of our progress and our commitment to developing highly differentiated vascular product solutions,” said Gary Maharaj, President and CEO of Surmodics. “Our Telemark microcatheter incorporates advanced technology that enables an exceedingly low crossing profile, excellent trackability and resistance to kinking, even in complex coronary and peripheral lesions, where there is still a great market need.”
The development of the Surmodics Telemark .014” support microcatheter is a step forward in the Company’s strategy to be a provider of whole-product vascular solutions for its medical device customers. Surmodics has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter and specialty catheter solutions.
About Surmodics, Inc.
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated whole-product solutions that are designed to address unmet clinical needs for its medical device customers and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations regarding the Company’s strategy to transform to a provider of whole-product vascular solutions, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including (1) our ability to successfully develop, obtain regulatory approval for, and commercialize our proprietary products; (2) our ability to achieve expected benefits from our acquisitions; and (3) the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2017, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
