SINOMED, a developer of innovative neuro- and cardiovascular technologies, announced the completion of the 1-year follow-up in the PIONEER-III, randomized global trial evaluating the BuMA Supreme Drug-Eluting Coronary Stent (DES). Once completed, the company plans to submit the data to the U.S. Food and Drug Administration and Japanese Pharmaceuticals and Medical Devices Agency for the device approval.
“Despite the problems of managing the COVID pandemic, everyone involved in the study has made a tremendous effort to finish the necessary clinical follow-up,” said Martin B. Leon, MD, Columbia University Medical Center, USA, and Chairman of the Executive Committee of the PIONEER III study. “We can now focus on analyzing the data and planning the presentation and publication of the findings in the second half of 2020. The completion of this study could help lead SINOMED to become the first Chinese company to gain FDA approval of a drug-eluting stent.”
The PIONEER III trial completed follow-up of 1,631 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 Supreme over the control arm.
The BuMA Supreme is a new evolution of DES, developed to maximize functional healing of the blood vessels after a stent implantation. Its innovative design utilizes a combination of a novel drug release kinetic and proprietary coating technology to allow for a quicker return of natural cellular functionality, in comparison to other commercially available DES. This healthy restoration is believed to contribute to better long-term clinical outcomes.
The BuMA Supreme with a new cobalt chromium platform and delivery system is CE approved and available for distribution in select regions. BuMA Supreme is an investigational device in the United States and Japan.
Sino Medical Science Technology Inc. (SINOMED), a global medical device company engaged in research, development, production and commercial distribution of interventional devices. We are focused on developing breakthrough technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease.