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: Stellarex 0.035” OTW Drug-coated Angioplasty Balloon
PMA Applicant: Philips Image Guided Therapy Corporation
Address: 6655 Wedgwood Road N, Suite 105, Maple Grove, MN 55311 USA
Approval Date: March 25, 2022
Approval Letter: Approval order
What is it?
The Stellarex 0.035” OTW Drug-coated Angioplasty Balloon (Stellarex 035 DCB) uses a drug-coated balloon 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 which may help prevent the arteries from narrowing again (restenosis).
This approval expands the indications for use to include re-opening the part of a blood vessel that is within a previously placed stent.
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 blocked or narrowed part. The Stellarex 0.035” OTW Drug-coated Angioplasty 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 Stellarex 0.035” OTW Drug-coated Angioplasty 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. The buildup can cause hardening and/or narrowing of the arteries (atherosclerosis), which limits 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 Stellarex 0.035” OTW Drug-coated Angioplasty Balloon opens up a narrow or blocked artery in the thigh or knee. It can also be used to open up narrowing of a blood vessel within an already-placed stent. At 12 months, the Stellarex 0.035” OTW Drug-coated Angioplasty Balloon was able to keep 76.3% of arteries open. When used within a stent, the Stellarex 035 DCB was able to keep 58.8% of arteries open.
When should it not be used?
The Stellarex 0.035” OTW Drug-coated Angioplasty Balloon should not be used in:
- Patients with a known hypersensitivity (allergy) to paclitaxel or drugs with similar characteristics as paclitaxel.
- Patients who cannot take recommended blood-thinning or anti-clotting medicines.
- Women who are breastfeeding, pregnant, or intend to become pregnant and men who intend to father children.
- Arteries that carry blood to the heart (coronary), kidneys (renal), brain (cerebrovascular), or branch off from the largest artery (supra-aortic).
- If a doctor decides that the patient’s artery blockage will not allow complete inflation of the angioplasty balloon.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data
- Labeling – Patient Resource Guide
- PMA Database entry