Biosensors, a developer, manufacturer and marketer of medical devices, has announced the enrolment of the first patient in REFORM - a prospective, randomised, non-inferiority trial to determine the safety and efficacy of the Biolimus A9 Drug Coated Balloon for the treatment of in-stent restenosis: first-in-man trial.
This trial is targeting CE-mark approval for their new Biolimus A9 drug coated balloon (DCB) and will include 34 sites in Germany, Italy, Ireland, Spain, the United Kingdom and South Korea.
The trial is being conducted under the leadership of Prof Robert Byrne, director of cardiology, Mater Private Hospital, and chair of cardiovascular research at RCSI University, both in Dublin.
He said: “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 drug coated balloon 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 randomised clinical trial of the BA9 DCB in patients with small vessel.
The BA9 DCB represents the latest development in Biosensors balloon technology featuring a BA9 formulation coated onto the balloon’s abluminal surface. BA9 is Biosensors proprietary highly lipophilic anti-restenotic drug, developed specifically for use in coronary vascular applications.
Until recently, Paclitaxel was used exclusively as the active agent for Drug Coated Balloon (DCB) technology, but this cytotoxic agent has a narrow therapeutic window and is no longer used as a coating on coronary stents.
Biosensors new chief medical officer Prof Keith G Oldroyd said: “The interventional cardiology community has been waiting for the introduction of a BiolimusA9 coated balloon and we are delighted that the REFORM trial has started recruitment, particularly given the challenges of conducting clinical research during the COVID-19 pandemic. Coupled with the ongoing study in China, we hope these trials will confirm the safety and efficacy of this new device and expand the treatment options available to doctors treating patients with coronary heart disease.”
