Surmodics Gets FDA Approval for SurVeil Drug-Coated Balloon

By Dean Seal

Surmodics has received approval from the U.S. Food and Drug Administration for its SurVeil drug-coated balloon to be used in unblocking blood vessels.

The medical device company said Tuesday it can now market and sell the SurVeil DCB to U.S. physicians for percutaneous transluminal angioplasty of de novo or restenotic lesions in femoral and popliteal arteries that have reference vessel diameters of 4 millimeters to 7 millimeters.

Surmodics is set to receive a $27 million milestone payment from Abbott Laboratories, which has exclusive worldwide commercialization rights for the balloon. Surmodics will manufacture the device and earn revenue from product sales to Abbott, along with a share of profits from Abbott's third-party sales.

Chief Executive Gary Maharaj said the FDA's approval is a major milestone in the company's mission to help sufferers of peripheral artery disease.

The balloon received mark certification in the European Union in June 2020.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

June 20, 2023 07:08 ET (11:08 GMT)

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