- Surmodics (NASDAQ:SRDX) is up 2% premarket on light volume in reaction to Breakthrough Device designation in the U.S. for its Sundance sirolimus-coated balloon catheter for below-the-knee arterial lesions in patients suffering from critical limb ischemia and infrapopliteal arterial disease.
- The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.