SurVeil Drug-Coated Balloon – P210025
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: SurVeil Drug-Coated Balloon
PMA Applicant: Surmodics, Inc.
Address: 9924 West 74th Street, Eden Prairie, MN 55344
Approval Date: June 16, 2023
Approval Letter: Approval Order
What is it?
The SurVeil Drug-Coated Balloon is a drug-coated balloon used to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). The balloon is coated on its outer surface with the drug paclitaxel; a drug which may help prevent the arteries from narrowing again (restenosis).
How does it work?
A traditional angioplasty balloon catheter is inserted through the blood vessels, across the blockage or narrowing, and inflated to partially open the blockage or narrowing. The SurVeil Drug-Coated Balloon is then used to fully open the narrowed portion of the artery and apply the drug to the artery wall.
When is it used?
The SurVeil Drug-Coated Balloon is used when arteries in the thigh and knee are narrowed or blocked as a result of peripheral artery disease. PAD occurs when fatty material (plaque) builds up in these arteries, which can cause hardening and/or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the body. People with PAD may experience lifestyle-limiting symptoms, such as leg pain, or serious complications, including skin ulcers or gangrene.
What will it accomplish?
The SurVeil Drug-Coated Balloon opens up a narrow or blocked artery in the thigh and knee. This device was shown to be as safe and effective as other drug-coated balloons. At 12 months, the SurVeil Drug-Coated Balloon was able to keep 82.2% of arteries open.
When should it not be used?
The SurVeil Drug-Coated Balloon should not be used in:
- Arteries that carry blood to the heart (coronary), kidneys (renal), brain (cerebrovascular), or branch off from the largest artery (supra-aortic).
- Patients with a known hypersensitivity to paclitaxel or drugs with similar characteristics as paclitaxel.
- Patients who cannot take recommended medicines that thin the blood and prevent blood clots.
- Women who are breastfeeding, pregnant, or intend to become pregnant; or men intending to father children.
- Patients whose doctors judge that their narrowing or blockage (lesion) will prevent proper placement of the delivery system.
Additional information (including warnings, precautions, and adverse events):