HT Supreme is a novel stent, customised to advance the wound-healing and restore naturally protective vessel function for patients
HT Supreme Drug-Eluting Stent system. (Credit: Sino Medical Sciences Technology Inc.)
China-based interventional devices maker Sinomed has unveiled positive results for its HT Supreme Drug-Eluting Stent (DES) System from PIONEER 3 clinical trial.
The PIONEER 3 study enrolled 1,629 patients in centres across Belgium, Canada, France, Germany, Japan, Netherlands, Spain, Switzerland, UK, and the US.
Target lesion failure (TLF) at one-year was the primary composite endpoint of the trial.
In the study, the company’s HT Supreme system showed equivalent safety and effectiveness with other available top DES system.
It met the non-inferiority endpoint at a TLF outcome of 5.4%, compared to 5.1% from the control arm of Xience and Promus devices.
PIONEER 3 trial Europe co-principal investigator Andreas Baumbach said: “The HT Supreme performed very well and showed results non-inferior to the current market leading stent.
“I am now looking forward to see whether the novel design of the stent platform and drug delivery system will result in superior outcomes in future long-term follow-up out to five years.”
HT Supreme is a novel stent, customised using patented designs and unique processes to advance the wound-healing and restore naturally protective vessel function for patients.
The analysis of secondary endpoints showed numerically superior results for HT Supreme in cardiac death or target-vessel myocardial infarction compared the control arm.
Also, lower late stent thrombosis data suggests superior safety for the HT Supreme.
Sinomed intends to submit the study data to the regulatory agencies in the US and Japan, to obtain approvals in respective countries.
The company is engaged in research, development, production, and commercial distribution of interventional devices for the treatment of coronary, neurovascular and heart diseases.
Sinomed chairman and chief executive officer Jianhua Sun said: “PIONEER 3 is the cornerstone of our extensive, international clinical trial program and I am very grateful for the support we have had from investigators around the world.
“Now is a very exciting time for us as we are in the early stage of product launch where we are putting our clinical learnings towards real-life clinical experience.”
In August this year, Sinomed has announced first commercial implantation of the HT Supreme DES at University Hospital Galway, and launch of the product in Europe.