Sinomed has announced the first commercial implantation of the HT Supreme drug-eluting stent (DES) at University Hospital Galway in partnership with the National University of Ireland Galway (NUI Galway, Galway, Ireland), marking the start of the European launch of the device.
The procedure was successfully performed by Faisal Sharif, professor of translational cardiovascular medicine and innovation at NUI Galway and Consultant Interventional Cardiologist at Galway University Hospitals, Galway, Ireland.
Sharif is one of four global principal investigators of the PIONEER IV trial, which is a prospective, randomised trial that will take place in 30 hospitals across Europe, enrolling 2,540 patients suffering from any type of coronary artery disease, including acute heart attack, chronic complaints or vessel narrowing.
Patients eligible will undergo a non-invasive physiological vessel selection process to determine which vessel requires stenting. All patients enrolled into the trial will use the HT Supreme DES and be required to take one month dual-antiplatelet therapy (DAPT) after stenting.
Sharif said: “We are delighted to implant the HT Supreme stent from Sinomed at University Hospital Galway in partnership with National University of Ireland Galway. Early indications show the device deliverability to be good and the novel stent technology offers faster stent endothelialisation, which will potentially reduce the need for aggressive antiplatelet treatment. Reducing the need for multiple antiplatelet treatment is an important issue especially with an ageing population and multiple comorbidities of patients who require coronary stenting.”
The healing-targeted HT Supreme DES was approved for the treatment of patients with narrowing or blockages to their coronary arteries. This new device gives clinicians an additional choice of a device that is tailored to help patients accelerate their wound-healing process and restore their naturally protective vessel function after a stenting procedure.
“The HT Supreme represents a different DES technology by offering a solution specifically designed to encourage rapid healing following implantation,” said Alain Aimonetti, Sinomed Europe’s chief commercial officer, sales, marketing and clinical affairs. “This product launch is a significant landmark for Sinomed Europe as we begin the commercial phase of our operations. Additionally, we will continue our clinical commitment with further investments in the HT Supreme’s robust clinical programme.”
“We are honoured to be the first Chinese company to partner with the CORRIB Research Centre for Advanced Imaging and Core Laboratory for the PIONEER IV study,” said Jianhua Sun, chairman and chief executive officer of Sinomed. “Based on previous clinical experience, the HT Supreme has been documented to be safe and effective. This new study shortens the dual antiplatelet medication for all patients, which will reduce the risk of bleeding, and assess a new method to further improve the quality of treating patients.”
The PIONEER IV is an investigator driven trial sponsored by NUI Galway and is centrally coordinated by the University’s CORRIB Research Centre for Advanced Imaging and Core Laboratory, led by Patrick W Serruys, established professor of interventional medicine and innovation, and William Wijns, Science Foundation Ireland professor of interventional cardiology.