AGENT Paclitaxel-Coated Balloon Catheter – P230035
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: AGENT Paclitaxel-Coated Balloon Catheter
PMA Applicant: Boston Scientific Corporation
Address: One Scimed Place, Maple Grove, MN 55311
Approval Date: 02/29/2024
Approval Letter: Approval Order
What is it?
The AGENT Paclitaxel-Coated Balloon Catheter (Agent DCB) uses a narrow tube with a balloon on the end to reopen arteries that supply blood to the heart and are blocked or narrowed due to coronary artery disease (CAD). The balloon is coated on its outer surface with the drug paclitaxel, which may help prevent the arteries from narrowing again (restenosis).
A traditional angioplasty balloon catheter is inserted through the blood vessels and inflated to partially open the blockage or narrowing. The Agent DCB is then inserted to fully open the narrowed portion of the artery and apply the drug to the artery wall.
The Agent DCB is used when an artery supplying blood to the heart that was previously treated with a stent has again become narrowed or blocked because of CAD. CAD occurs when fatty material (plaque) builds up in these arteries, which can cause hardening or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the heart. People with CAD may experience lifestyle-limiting symptoms, such as chest pain or discomfort, weakness, and shortness of breath.
The Agent DCB will open up a narrow or blocked artery supplying blood to the heart. This device was shown to be safer and more effective than balloon catheters that are not coated with a drug when treating arteries previously treated with stents. At 12 months after the procedure, patients treated with the Agent DCB showed an 11.1% reduction in the occurrence of heart attack, death, and need for repeat procedure as compared to patients treated with uncoated balloon catheters.
The Agent DCB should not be used if you:
- Have a sensitivity to or have had an allergic reaction to paclitaxel.
- Have a blockage that is:
- A result of spasm of the artery.
- In an artery that is not in the heart.
- In the first part of the main artery supplying blood to left ventricle, the main pumping chamber of the heart.
- Are unable to take the recommended medications prescribed for after the procedure.
- Are pregnant, breastfeeding, planning to become pregnant, or planning to father a child.