The newly cleared low-profile catheter features the Eden Prairie, Minn.-based company’s low-friction, low-particulate Serene hydrophilic coating with a range of between 2mm to 10mm.
“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of differentiated products that are designed to advance the treatment of vascular disease. This regulatory milestone adds to the recent clearances of the Telemark .014″ Support microcatheter and the .014” BTK balloon dilatation catheter,” Surmodics prez & CEO Gary Maharaj said in a prepared statement.
Surmodics said that it expects to make the device available for distribution in the coming months.
In January, Surmodics said that it won 510(k) clearance from the FDA for its Telemark 0.014″ coronary and peripheral microcatheter, saying it planned to have the device on the U.S. market “in the coming months.”