CRMC Completes First Procedure with AGENT™ Drug-Coated Balloon to Treat Coronary In-Stent Restenosis

Image: Interventional Cardiologists Dr. Yan Yatsynovich and Dr. Stacy Brewington perform a heart stent with drug-coated balloon to treat coronary IRS.

Cookeville Regional Medical Center performed its first procedure on January 16, 2025, using the AGENT™ Drug-Coated Balloon (DCB). The innovative procedure was conducted to treat Gary Flatt, a patient with coronary artery disease and in-stent restenosis (ISR).

Dr. Stacy Brewington and Dr. Yan Yatsynovich’, both interventional cardiologists at CRMC, performed the procedure using the FDA-approved AGENT DCB. The device, coated with the anti-restenotic drug paclitaxel, is designed to deliver medication directly to the artery wall, helping to prevent ISR without adding another layer of metal stenting.

“Mr. Flatt had several stents before and was at a place where you do not want to continue placing metal stenting on top of what was already there,” explained Dr. Brewington. “Mr. Flatt has ISR, which is the narrowing of a previously stented coronary vessel by plaque or scar tissue. The AGENT DCB provided an ideal solution for his condition. Dr. Yatsynovich’ and I performed the procedure, and Mr. Flatt did excellent.”

Dr. Yatsynovich’ highlighted the importance of this development, stating, “While drug-eluting stents used to treat blocked coronary arteries provide good results for many patients, in-stent restenosis can still occur. Now, we have an option at Cookeville Regional to treat those patients instead of sending them elsewhere.”

The AGENT DCB received U.S. Food and Drug Administration (FDA) approval in early 2024. Clinical trials demonstrated its statistical superiority over uncoated balloon angioplasty, showing low event rates at 12 months. The device has been used to treat more than 100,000 patients globally and is commercially available in many international markets.

Buffy Key, CEO of Cookeville Regional Medical Center, emphasized the hospital’s commitment to bringing advanced treatments to the local community. “At Cookeville Regional, we want to be proactive in finding ways to keep patients closer to home when faced with a diagnosis of any kind. The work and dedication the cardiologists have at Cookeville Regional to bring the latest technology, treatment options, or procedures to our community is commendable. We are excited to bring this latest treatment option to the community.”