Biosensors announced today 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 the Biolimus A9 drug coated balloon (DCB) and will include 34 sites in Germany, Italy, Ireland, Spain, the UK and South Korea.
The trial is being conducted under the leadership of Robert Byrne, director of cardiology, Mater Private Hospital, and chair of Cardiovascular Research at RCSI University, Dublin, Ireland who 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”
Ralph Tölg, Segeberger Kliniken GmbH: Heart Center, Bad Segenberg, Germany enrolled the first REFORM patient—a 53 year old male who had developed in-stent restenosis (ISR) >10 years after his initial percutaneous coronary intervention (PCI). “After lesion preparation delivery of the BA9 DCB was smooth, with good angiographic result. We are all very excited to see the clinical and angiographic long-term results of this FIM-trial with a novel limus-DCB.”
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 disease, with first results expected in 2021.