In a significant breakthrough towards obtaining the major regulatory approvals for the BuMA Supreme Drug-Eluting Stent System, enrollment in the PIONEER III randomized, controlled trial has been completed by SINOMED. For assessing the safety & effectiveness of the BuMa Supreme DES & to support the United States’ & Japanese regulatory approvals to treat atherosclerotic coronary lesions, the PIONEER III trial is designed.
The chairman of the Executive Committee of the PIONEER III study & Managing Director at the Columbia University Medical Center, USA, Martin B. Leon, stated that BuMA Supreme brings an exciting new concept to drug-eluting stents with eG Coating technology & distinctive pharmacokinetics which targets a quicker return of functional healing. This earlier restoration can bring out safer long-term results by likely reducing late stent thrombosis & neo-atherosclerosis.
Firm’s 2nd-generation DES with eG Coating, BuMA Supreme, is a sirolimus drug & biodegradable polymer. The therapeutic coating has been designed for a targeted drug-release of fewer than 30 days, enabling the vessel to regain its natural healing ability faster than other DES. 2 months later, the biodegradable polymer is fully absorbed leaving an inert environment for improved healing to occur. The novel device will be having a cobalt-chromium stent platform & upgraded delivery system.
The PIONEER III trial completed enrollment of 1,632 patients at 74 sites in Europe, North America, and Japan. Patients with symptomatic heart disease were randomized 2 ratios 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 at 12 months and patients will be followed-up for 5 years post-study enrollment. In addition to this, the trial is powered for a strategic landmark analysis of TLF between 1 & 5 years.