Surmodics has received US FDA 510(k) clearance for its Telemark .014inch coronary support microcatheter. A press release reports that the company is making the catheter available for US distribution in the coming months, and states that it offers superior crossability for complex coronary lesions
According to the press release, 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 2.6Fr to 1.4Fr for effective penetration of tough, calcified lesions.
Gary Maharaj, president and CEO of Surmodics, comments: “This is another example of our progress and our commitment to developing highly differentiated vascular product solutions. 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 press release notes that the development of the Surmodics Telemark .014inch 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.