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Surmodics Sundance catheter a Breakthrough Device in U.S.

Oct. 29, 2019 8:49 AM ETSurmodics, Inc. (SRDX) StockSRDXBy: Douglas W. House, SA News Editor2 Comments
  • 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.

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