MedAlliance’s SELUTION4ISR Study Begins Enrollment in the United States

January 25, 2023—MedAlliance announced that the first patient in the United States has been enrolled in the SELUTION4ISR clinical trial, which is evaluating the company’s Selution SLR sirolimus drug-eluting balloon (DEB) with sustained limus release (SLR) in the treatment of in-stent restenosis (ISR).

In October 2022, the company announced it received an FDA investigational device exemption (IDE) for the trial, which is being conducted to support regulatory approval of the Selution SLR device in the United States.

The company advised that the initial patient in the United States was enrolled in the trial at MedStar Washington Hospital Center in Washington, DC. Additional centers in the United States will soon join enrollment of the SELUTION4ISR trial coronary study. The study has been ongoing outside the United States.

Don Cutlip, MD, and Professor Roxana Mehran, MD, are Coprincipal Investigators of the trial. Dr. Cutlip is Chief Medical Officer at Baim Institute for Clinical Research in Boston, Massachusetts. Prof. Mehran is Mount Sinai Professor in Cardiovascular Clinical Research and Clinical Trials at The Icahn School of Medicine at Mount Sinai in New York, New York.

“We are very excited to have enrolled our first United States patient,” commented Dr. Cutlip in the MedAlliance press release. “This study addresses the important unmet need of treatment for the ongoing problem of ISR without adding an additional layer of metal stent.”

Prof. Mehran added, “This is an exciting day for percutaneous coronary intervention in the United States. DEB is the standard of care for ISR around the world, with the exception of the United States. Treating coronary ISR is challenging and having DEB technology made available through a well-designed and -conducted randomized clinical trial is the next step. This trial is now underway, and this is great for our patients!”

In addition to the ISR study, MedAlliance recently announced IDE approval for a coronary de novo indication. The SELUTION DeNovo study, which has been conducted outside the United States, has enrolled > 800 patients of a planned 3,326 patients. The randomized coronary study is comparing a treatment strategy with the Selution SLR DEB versus a strategy using a limus drug-eluting stent.



In Europe, Selution SLR received CE Mark approval for the treatment of coronary artery disease in May 2020. The device is commercially available in Europe, Asia, the Middle East, the Americas (outside the United States), and most other countries where the CE Mark is recognized.