Surmodics Gets FDA Approval for SurVeil Drug-Coated Balloon
June 20 2023 - 7:23AM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
SurModics (NASDAQ:SRDX)
Historical Stock Chart
From May 2024 to Jun 2024
SurModics (NASDAQ:SRDX)
Historical Stock Chart
From Jun 2023 to Jun 2024