PIONEER-III clinical trial is evaluating the BuMA Supreme Drug-Eluting Coronary Stent (DES) and the results will be used to secure the US and Japanese regulatory approval
Sino Medical Science Technology (SINOMED), a developer of advanced medical technologies, has completed the one year follow-up in the PIONEER-III clinical trial of BuMA Supreme Drug-Eluting Coronary Stent (DES).
The BuMA Supreme is an advanced evolution of DES, developed to maximise functional healing of the blood vessels after a stent implantation.
Once completed, the company intends to use the study results to seek approval from the US Food and Drug Administration and Japanese Pharmaceuticals and Medical Devices Agency for the device.
PIONEER III study executive committee chairman Martin B Leon said: “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.
“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 participants in the PIONEER clinical trial received treatment using BuMA Supreme DES
The medical device company said that the PIONEER III trial has completed the follow-up of 1,631 patients at 74 sites in North America, Europe and Japan.
The study enrolled patients with symptomatic heart disease, and were randomised to receive the BuMA Supreme DES or any commercially available durable polymer everolimus-eluting stent.
Target lesion failure (TLF) at twelve months and patient follow-up for five years post study enrollment include the endpoint of clinical trial.
In addition, the clinical trial is aimed at a long-term landmark analysis of TLF between one and five years, examining the superiority of the BuMA Supreme over the control arm.
The advanced design of the device leverages a combination of a novel drug release kinetic and novel coating technology that allows a rapid return of natural cellular functionality, compared to other commercially available DES.
Furthermore, the BuMA Supreme with a new cobalt chromium platform and delivery system has been granted CE approval and is available for distribution in select regions.