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: Ranger Paclitaxel-Coated PTA Balloon Catheter
PMA Applicant: Boston Scientific Corporation
Address: Three Scimed Place, Maple Grove, MN 55311
Approval Date: October 30, 2020
Approval Letter: Link to Approval Order
What is it? The Ranger Paclitaxel-Coated PTA Balloon Catheter (Ranger 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 paclitaxel, a drug which may help stop 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 Ranger DCB 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 Ranger DCB is used when arteries in the thigh and knee are narrowed or blocked as a result of peripheral artery disease (PAD). 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 Ranger DCB will open up a narrow or blocked artery in the thigh and knee. The drug helps keep the artery open over time. This device was shown to be as safe and more effective than standard balloons with no drug coating. In a clinical study, at 12 months, the Ranger DCB was able to keep 83% of arteries open.
When should it not be used? The Ranger DCB should not be used in:
- Patients with known hypersensitivity to paclitaxel (or structurally-related compounds)
- Patients who cannot receive recommended antiplatelet or anticoagulation therapy
- Patients who are breastfeeding, pregnant, or are intending to become pregnant
- Patients intending to father children
- Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Additional information (including warnings, precautions, and adverse events):