July 13, 2020
One-Year Follow-Up Completed in PIONEER-III Trial of Sinomed’s Buma Supreme DES
July 13, 2020—Sino Medical Science Technology Inc. (Sinomed), a Tianjin, China–based developer of neuro- and cardiovascular technologies, announced the completion of 1-year follow-up in the randomized global PIONEER-III trial evaluating the Buma Supreme coronary drug-eluting stent (DES).
According to Sinomed, 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 either the Buma Supreme DES or any commercially available, durable, polymer, everolimus-eluting stent. The clinical trial’s endpoint is target lesion failure (TLF) at 12 months, and patients will be followed for 5 years from study enrollment. Additionally, the trial is powered for a long-term landmark analysis of TLF between 1 and 5 years, looking for superiority of the Buma Supreme over the control arm.
When the study is completed, the company plans to submit the data to the FDA and the Japanese Pharmaceuticals and Medical Devices Agency for approval of the device. Buma Supreme is currently an investigational device in the United States and Japan. The Buma Supreme device with a new cobalt-chromium platform and delivery system has received European CE Mark approval and is available for distribution in select regions.
Martin B. Leon, MD, with Columbia University Medical Center in New York, New York, is Chairman of the Executive Committee of the PIONEER III study. “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,” commented Dr. Leon in the company’s announcement. “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 DES.”