Eden Prairie-based medical device maker Surmodics on Monday announced Food and Drug Administration clearance for a slender device used to unblock clogged blood vessels, continuing its strategy of developing whole products rather than just device components.
Surmodics said it plans to make its Telemark 0.014-inch support microcatheter available for distribution in the U.S. under licenses with other medical device companies in coming months, after receiving 510(k) clearance for the device. (FDA records say the agency cleared the device on Jan. 12.)
The Telemark is designed to be inserted into a blood vessel in the heart or legs that is blocked with hard, calcified plaque, typically before the insertion of a second device that can further open the vessel and potentially leave a stent behind. The Telemark is coated with a proprietary "hydrophilic" coating designed to make it slippery while not leaving particles behind in the body.
"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 news release.
Long known as a supplier of components for drug delivery and medical device surface modifications, Surmodics has in recent years expanded its offerings to the design and manufacture of whole products for vascular procedures.
Last fall, Surmodics announced FDA clearance for its 0.014-inch PTA balloon catheter, which is used to treat lesions in the legs from peripheral artery disease. Development of whole products follows Surmodics' 2015 acquisitions of Creagh Medical and its manufacturing plant in Ballinasloe, Ireland, and Surmodics' 2016 acquisition of Plymouth-based design-and-development firm NorMedix.
Surmodics, which has about 150 employees in the U.S. and 100 more in other countries, saw its shares close down 1 percent on Monday, at $29.15. The company reported income of $3.9 million on $73 million in revenue for the fiscal year that ended in September.
Joe Carlson • 612-673-4779
