Shanghai, China (October 17, 2016) - MicroPort Scientific Corporation (HKSE: 0853) ("MicroPort®") announced today that it has completed patient enrollment for its European clinical trial called TARGET All Comer ("TARGET AC") for its Firehawk® Rapamycin Target Eluting Coronary Stent ("Firehawk®"). The final patient to enroll in the TARGET AC clinical trial was enrolled by Dr. Niels van Royen of VU University Medical Center (VUmc), a university hospital affiliated with the VU University Amsterdam, in The Netherlands. The first patient for the TARGET AC clinical trial was enrolled in December 2015 by Dr. Lene Holmvang, Rigshospitalet University Hospital, Copenhagen, Denmark. With concerted efforts from all of the study investigators, the TARGET AC clinical trial met its objective to recruit and enroll a total of 1,656 patients, successfully accomplishing this objective in 10 months which was ahead of plan.
"The Firehawk® stent is a very conformable and deliverable stent that is well suited for treatment of complex lesion subsets," said William Wijns, M.D., PhD, Cardiovascular Research Center, OLV Aalst, Belgium, and principal investigator for the study. "I am very pleased that the TARGET AC trial enrolled so quickly and look forward to the study results for this innovative stent which was designed for quick and optimal vessel healing. The innovative groove design and the absorbable polymer of the Firehawk® stent system has the potential to positively impact patient care by further reducing the risk of late adverse events and the need for device-mandated prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding as well as increased patient treatment cost."
The TARGET AC clinical trial is designed to further assess the safety and efficacy of Firehawk® for the treatment of atherosclerotic coronary lesions in an all-comers, regardless of disease complexity and co-morbidities, real world population. All patients enrolled in the clinical trial have been randomized 1:1 to receive Firehawk® or Abbott's Xience family of drug-eluting stents. The clinical trial's primary endpoint is the target lesion failure (TLF) rate at twelve (12) months, and patients will be followed up for five (5) years post study enrollment.
Firehawk® is the 3rd generation of MicroPort®'s internally developed, drug-eluting stent product family and offers a highly innovative stent groove design. It features a 100% biodegradable PLA polymer and sirolimus drug combination, which ensures a steady and constant drug release rate and complete absorption of the polymer shortly after drug elution ends at nine months. These grooves act as depository wells containing the polymer and drug combination, which allows Firehawk® to have a targeted release of the drug to the coronary vessel wall. This unique abluminal groove-filled design allows Firehawk® to overcome potential drawbacks experienced with other conventional drug eluting stents. In addition, in patients with complex lesions and complex PCI technique, Firehawk® overcomes concerns with the durability of the polymer coating in conventional DES.
The clinical trial enrolled patients in twenty one (21) sites in ten (10) countries across Europe including Austria, Belgium, Denmark, Germany, France, Italy, Spain, The Netherlands, Poland, United Kingdom.
Firehawk® has received CE Mark approval in January 2015 and is currently available in select markets.