North America, Europe and Japan trial seeks approval for the US and Japanese markets
In a significant milestone toward obtaining key regulatory approvals for the BuMA Supreme Drug-Eluting Stent (DES) System, SINOMED has completed enrollment in the PIONEER III randomized, controlled clinical trial. The PIONEER III trial is designed to assess the safety and effectiveness of the BuMA Supreme DES and support U.S. and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.
“BuMA Supreme brings an interesting new concept to drug-eluting stents with eG Coating(TM) technology and unique pharmacokinetics that targets a faster return of functional healing,” said Martin B. Leon, MD, Columbia University Medical Center, USA, and Chairman of the Executive Committee of the PIONEER III study. “This earlier restoration can lead to safer long-term results by possibly reducing late stent thrombosis and neo-atherosclerosis.”
BuMA Supreme is the company’s second-generation DES with eG Coating, biodegradable polymer and sirolimus drug. The therapeutic coating has been formulated for a targeted drug-release of less than 30 days, allowing the vessel to regain its natural healing ability sooner than other DES. After two months, the biodegradable polymer is completely absorbed leaving an inert environment for better healing to occur. The new device will have a cobalt chromium stent platform and upgraded delivery system.
The PIONEER III trial completed enrollment of 1,632 patients at 74 sites in North America, Europe and Japan. Patients presenting with symptomatic heart disease were randomized 2:1 to receive the BuMA Supreme DES or any commercially available durable polymer everolimus-eluting stent. The clinical trial’s endpoint is target lesion failure (TLF) at twelve months and patients will be followed-up for five years post study enrollment. Additionally, the trial is powered for a long-term landmark analysis of TLF between one and five years; looking for superiority of the BuMA DES over the control arm.
“We are the first Chinese stent company to take on such an ambitious trial,” said Jianhua Sun, PhD., Chief Executive Officer of SINOMED. “BuMA Supreme is just one piece of our overall drug-eluting platform strategy and we are heavily investing in clinical trials to show the long-term benefits of this device while continuing our development of future generations.”