Surmodics has received FDA clearance to sell its Telemark .014” coronary and peripheral support microcatheter. The 510(k) nod positions Surmodics to start shipping a device designed for use in the treatment of complex coronary and peripheral lesions.
Telemark brings together two Surmodics’ technologies, namely its Xtreme composite shaft and Pristyne hydrophilic coating. Surmodics thinks this gives the microcatheter properties that will make it a valuable tool for doctors.
“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,” Surmodics CEO Gary Maharaj said in a statement.
Surmodics had hoped to secure the 510(k) clearance before the end of 2017 but was forced to push back its timeline by a request for more data from the agency. The company responded by refiling late last year and has now been rewarded with a 510(k) clearance.
Securing the approval sets Surmodics up to embark on the next stage of the lifecycle of the device. Surmodics plans to make the product available for U.S. distribution in the coming months. And it has previously discussed entering into deals covering the device. Talking last year, Maharaj said the talks would advance once the approval was in place.