Manatee Memorial Hospital Becomes First in Southwest Florida to Use New FDA-Approved Drug-Eluting Balloon for Coronary Artery Disease

Dr. James Nguyen (center) and members of the Cath Lab team

Manatee Memorial Hospital is the first hospital in Southwest Florida to use the newly FDA-approved SELUTION SLR™ Drug-Eluting Balloon, providing patients with a new treatment option for coronary arteries that have again become narrowed inside a previously placed stent. The technology, manufactured by Cordis, received U.S. Food and Drug Administration approval in September 2026 for the treatment of coronary in-stent restenosis (ISR). Manatee Memorial's use of the technology places the hospital among the earliest in the nation to offer this newly approved treatment.

In-stent restenosis occurs when tissue grows inside a coronary stent and causes the artery to narrow, potentially restricting blood flow to the heart. Traditionally, treatment may involve placing another stent inside the existing one. During the procedure with SELUTION SLR, an interventional cardiologist guides a specialized balloon catheter to the narrowed area of the coronary artery. When the balloon is inflated, it delivers the medication sirolimus directly to the artery wall. The balloon is then removed, leaving no additional permanent implant behind.

"What's exciting about this technology is that it is a less-invasive and innovative option for treating patients," said Dr. James Nguyen, MD, FACC, FSCAI, Interventional Cardiologist at Manatee Memorial and the first to use this technology at the facility. "Instead of automatically adding another layer of metal, we can use a balloon to deliver medication directly to the vessel wall and then remove the balloon. For appropriately selected patients, that can be a very attractive treatment strategy."

SELUTION SLR uses tiny drug-containing reservoirs incorporated into the balloon's coating. The technology is designed to provide a controlled, sustained release of sirolimus for up to 90 days. Sirolimus is an anti-proliferative medication that helps inhibit the tissue growth associated with restenosis.

"Manatee Memorial has a long history of bringing advanced cardiovascular technology to our community, and we are proud to be among the first hospitals in the country to offer this newly approved treatment," said Collin Weaver, Interim CEO of Manatee Memorial Hospital. "Innovation matters when it can translate into more options for our patients. This technology represents another example of our commitment to providing advanced heart care close to home."

The FDA approval of SELUTION SLR is specifically for treating coronary in-stent restenosis. The pivotal SELUTION4ISR clinical trial enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil and Europe and demonstrated that the drug-eluting balloon was non-inferior to the study's standard-of-care treatment at 12 months. Importantly, SELUTION SLR is currently the first and only sirolimus drug-eluting balloon approved by the FDA for use in the United States.

Manatee Memorial's involvement with SELUTION technology also builds on the hospital's history of participating in cardiovascular device research. Interventional Cardiologist S. Jay Mathews, MD, MS, FACC, FSCAI, previously served as a co-principal investigator in a U.S. clinical study evaluating SELUTION SLR in patients with complex peripheral arterial disease. Dr. Mathews was also the second physician to perform the procedure at Manatee Memorial.

"This is an important moment for cardiovascular care because we're moving toward more individualized treatment strategies," Dr. Mathews said. "The goal isn't necessarily to put more metal in an artery every time a problem occurs. Having technologies that enable us to deliver effective therapy while preserving future treatment options is an important advancement."

Manatee Memorial Hospital's Heart and Vascular Center provides comprehensive cardiovascular services, including diagnostic testing, interventional cardiology, structural heart procedures, cardiac catheterization and treatment for complex cardiovascular conditions.