SURMODICS GETS FDA OK TO SELL TELEMARK MICROCATHETHETER
The U.S. Federal Food and Drug Administration has given Surmodics clearance to sell its Telemark .014-inch coronary and peripheral support microcatheter. The 510(k) approval allows Surmodics to start shipping a device designed for use in the treatment of peripheral lesions and complex coronary and peripheral lesions.
Telemark brings together two Surmodics’ technologies: Xtreme composite shaft and Pristyne hydrophilic coating. Surmodics CEO Gary Maharaj said 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,” Maharaj said.
Securing the approval sets Surmodics up to embark on the next stage of the lifecycle of the device. He said Surmodics plans to make the product available for U.S. distribution in the coming months. And he has previously discussed entering into deals covering the device. VTN
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