Surmodics' Telemark Support Microcatheter Receives FDA Clearance
January 22, 2018—Surmodics, Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration for the company's Telemark 0.014-inch peripheral and coronary support microcatheter. The device will be available for distribution in the United States in the coming months.
According to Surmodics, the Telemark support microcatheter provides crossability for complex coronary and peripheral lesions. The device combines Surmodics' Xtreme composite shaft technology with the company's Pristyne hydrophilic coating for deliverability, kink resistance, and lesion crossing. The Pristyne hydrophilic coating offers lubricity and low particulates. The Telemark microcatheter's tapered-profile design has an outer diameter ranging from 1.4 to 2.6 F for effective penetration of calcified lesions, noted the company.