AGENT™ Drug Coated Balloon for Treatment of Coronary In-stent Restenosis (ISR)

Saint Alphonsus is proud to be the first and only health system in the region to use the AGENT™ Drug-Coated Balloon (DCB) to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.

The AGENT™ DCB is used when a patient needs their artery that has previously had a stent implanted, re-opened due to narrowing caused by plaque or scar tissue, the device is inserted and transfers a therapeutic dose of paclitaxel to the artery wall to help prevent ISR reoccurrence. With its approval by the U.S. Food and Drug Administration (FDA) in 2024, it is the first drug-coated coronary balloon in the U.S. and provides a dedicated treatment option for the challenging condition of ISR. The AGENT DCB is also commercially available in many international markets and has been used to treat more than 100,000 patients globally.

Traditional therapies used to treat ISR in the U.S. have included placing additional layers of metal stents, uncoated balloon angioplasty and radiation, all of which may not provide ideal outcomes in some cases.

Benefits of the AGENT DCB include:

• Allow for future treatment options
• Lower adverse event rates, including restenosis
• Avoid the use of another layer of metal stent
• Expand treatment options for a disease with limited available therapies
• Provide more durable results than other available treatment options