A cardiologist at Good Samaritan Medical Center in West Palm Beach has performed South Florida's first procedure using a newly approved drug-coated balloon designed to treat stents that have become narrowed or blocked again, a condition known as coronary in-stent restenosis. The milestone came less than two months after the device won federal approval, giving some heart patients a way to avoid getting yet another stent implanted.
Good Samaritan Medical Center, part of Palm Beach Health Network, says it is the first hospital in South Florida to perform a procedure using the SELUTION SLR drug-eluting balloon for this purpose. The hospital's report identifies invasive-interventional cardiologist Dr. Brijeshwar Maini as the physician who completed the procedure. In-stent restenosis occurs when a previously placed coronary stent becomes narrowed or blocked again, and it can happen because of recurrent plaque buildup or tissue growth inside the stent, which reduces blood flow to the heart.
Doctors have traditionally addressed the problem by placing another stent on top of the old one, but that approach carries its own downsides. Additional stents may increase the risk of complications for patients who have already had multiple procedures, and they can limit future treatment options down the road.
A Balloon Instead of Another Stent
The SELUTION SLR balloon is designed to deliver a consistent and predictable release of the drug sirolimus over 90 days, targeting the biological processes that contribute to restenosis rather than leaving behind more permanent metal hardware. Dr. Maini described the appeal of the option in a statement carried by the hospital's report. “This approach gives us another way to treat these blockages in some patients without adding another stent,” he said, adding that avoiding another stent can help preserve patients' future treatment options.
The device received federal approval for treating coronary in-stent restenosis on September 21, 2026, according to Cordis, the device's manufacturer. That approval followed the SELUTION4ISR trial, which Cordis reports enrolled more than 400 patients across 48 sites and met its primary endpoint of non-inferiority at the 12-month mark. Among all randomized patients in that trial, target lesion failure rates came in at 15.2% for SELUTION SLR compared with 13.5% for the standard of care, per the same company report.
Why In-Stent Restenosis Keeps Coming Back
The problem SELUTION SLR is meant to address is not rare. Nearly 1 million percutaneous coronary interventions are performed annually in the United States, and roughly 10% of them are addressing in-stent restenosis, according to Cordis.
A state-of-the-art review published by the American College of Cardiology's journal, JACC, found that even with today's drug-eluting stent platforms, restenosis and the need for repeat procedures still occur at a rate of 1% to 2% per year. The same review found that once restenosis recurs, it tends to come back again at escalating rates — 8.3% after a first reintervention, 17.1% after a second, and 22.8% after a third — and that stacking multiple layers of metal stent is linked to progressively higher risk of the cycle repeating.
Good Samaritan's Cardiac Program
Dr. Maini also leads Good Samaritan Medical Center's Center for Preventive Cardiac Medicine, which the hospital says provides advanced diagnostic services designed to catch heart conditions before they become critical. The hospital has begun treating eligible patients with the new balloon and has separately expanded its cardiac capabilities to offer the Watchman FLX Pro device, part of what it describes as an ongoing commitment to advancing cardiovascular care.
Good Samaritan is a 333-bed acute care hospital that has served Palm Beach County and the Treasure Coast for more than 100 years, offering services that span orthopedic care, women's care, general surgery, emergency services, urology, bariatric surgery, cardiac services, and cancer care. Its cancer center holds accreditation from the Commission on Cancer and from the American College of Surgeons' National Accreditation Program for Breast Cancer.
Good Samaritan was not alone in adopting the new technology quickly. Manatee Memorial Hospital says it became the first hospital in Southwest Florida to use the SELUTION SLR balloon, according to its own announcement, and credits interventional cardiologist Dr. James Nguyen as the first physician to use the technology there, as reported by Pulse of Manatee. Good Samaritan Medical Center has separately earned the Joint Commission's Gold Seal of Approval for total hip and knee replacement, shoulder replacement, and spine surgery, and Healthgrades' 100 Best Hospital Award for spine surgery and outpatient orthopedic excellence.
