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Surmodics gets FDA 510(k) clearance for Telemark coronary/peripheral support microcatheter

Published 23 January 2018

Surmodics has received the US 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.

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. 



Source: Company Press Release