Surmodics gets US FDA 510(K) clearance for Telemark support microcatheter

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Surmodics has announced receiving US FDA 510(k) clearance for its Telemark 0.014” coronary and peripheral support microcatheter. The company is making this product available for US distribution in the coming months.

The Telemark support microcatheter offers crossability for complex coronary and peripheral lesions and combines the company’s Xtreme composite shaft technology with a high-performance Pristyne hydrophilic coating that together provide deliverability, kink resistance and lesion crossing, a press release says. The Telemark microcatheter’s tapered profile design has an outer diameter ranging from 2.6F to 1.4F for effective penetration of tough, calcified lesions.

“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,” said Gary Maharaj, president and CEO of Surmodics.

The development of the Surmodics Telemark 0.014” 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.

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