July 7, 2020
MedAlliance Commences IDE Trial of Selution SLR 014 DCB to Treat In-Stent Restenosis
July 7, 2020—MedAlliance announced enrollment of the first patient in its study of the Selution SLR 014 for the treatment of in-stent restenosis (ISR). Selution SLR 014 is a sirolimus drug-eluting balloon (DEB) with sustained limus release (SLR). The first patient was enrolled by Professor Pascal Vranckx, MD, at Hartcentrum Hasselt in Hasselt, Belgium.
The study, which is being conducted under an investigational device exemption, will support submission for FDA approval. The Selution SLR has received CE Mark approval and is commercially available in Europe and countries where the CE Mark is recognized.
According to the company, the prospective, randomized, single-blind, multicenter study aims to demonstrate the safety and efficacy of Selution SLR in the treatment of ISR with either drug-eluting stents (DESs) or bare-metal stents (BMSs).
The study will include patients with BMS or DES ISR involving a native coronary artery with a reference vessel diameter of 2 to 4.5 mm. Up to 418 patients will be enrolled at approximately 60 sites in the United States and Europe. They will be randomized to receive either Selution SLR or standard of care (a control group with a current DES or a non-DEB angioplasty).
The primary endpoint for effectiveness of the study is target lesion failure, defined as all cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 12 months. Follow up will be conducted at 1 month, 6 months, 12 months, and annually through 5 years.
The study’s Principal Investigator is Donald Cutlip, MD, Professor of Medicine at Harvard Medical School and Chief Medical Officer at the Baim Institute for Clinical Research in Boston, Massachusetts.
In May 2020, MedAlliance announced European CE Mark approval for the Selution SLR for the treatment of coronary artery disease. In February 2019, MedAlliance announced that it has been granted FDA Breakthrough Device designation for Selution for the treatment of coronary artery disease. The company received CE Mark approval for Selution SLR for the treatment of peripheral artery disease in February 2020.