August 13, 2020
First Patient Enrolled in REFORM Trial of Biosensors’ Biolimus A9 DCB to Support CE Mark Approval
August 13, 2020—Biosensors International Group, Ltd. announced the enrollment of the first patient in the prospective, randomized, noninferiority REFORM trial, which aims to determine the safety and efficacy of the company’s Biolimus A9 drug-coated balloon (DCB) for the treatment of in-stent restenosis. The first-in-human trial is intended to support CE Mark approval for the Biolimus A9 DCB.
The device features Biosensors’ Biolimus A9 formulation coated onto the balloon’s abluminal surface. Biolimus A9 is a highly lipophilic antirestenotic drug, developed for use in coronary vascular applications.
Patients will be enrolled at 34 sites in Germany, Italy, Ireland, Spain, the United Kingdom, and South Korea.
Professor Ralph Tölg, MD, enrolled the first patient in the REFORM trial at the Segeberger Kliniken in Bad Segeberg, Germany. The male patient, age 53 years, had developed in-stent restenosis at > 10 years after his initial percutaneous coronary interventions (PCI).
Prof. Tölg commented in the company’s press release, “After lesion preparation, delivery of the Biolimus A9 DCB was smooth, with good angiographic result. We are all very excited to see the clinical and angiographic long-term results of this first-in-human trial with a novel limus-DCB.”
The REFORM trial is being led by Professor Robert Byrne, MD, Director of Cardiology at Mater Private Hospital and Chair of Cardiovascular Research at RCSI University in Dublin, Ireland.
Prof. Byrne commented in the company's announcement, “The REFORM trial is testing the first-ever Biolimus A9-coated balloon and builds on the success of the LEADERS and LEADERS FREE trials, which demonstrated the excellent safety and efficacy of Biolimus A9-eluting coronary stents. If successful, this new [DCB] will expand the treatment options for patients with in-stent restenosis undergoing repeat PCI.”
In China, as part of the global registration process, Biosensors has completed the recruitment of a randomized clinical trial of the Biolimus A9 DCB in patients with small vessel disease, with first results expected in 2021, stated the company.