SurModics (NSDQ:SRDX) said today that it won 510(k) clearance from the FDA for its Telemark 0.014″ coronary and peripheral microcatheter, saying it plans to have the device on the U.S. market “in the coming months.”
The Eden Prairie, Minn.-based medical device company said Telemark combines its Xtreme composite shaft technology with its Pristyne hydrophilic coating and is designed to cross lesions in the coronary and peripheral vasculature.
“This is another example of our progress and our commitment to developing highly differentiated vascular product solutions,” president & CEO Gary Maharaj said in prepared remarks. “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.”