Shanghai, China (December 18, 2015) - MicroPort Scientific Corporation ("MicroPort") announced that the first patient was enrolled in the Firehawk™ TARGET All Comer ("TARGET AC") clinical trial in Europe. This multi-center trial is designed to further assess the safety and effectiveness of the Firehawk™ Rapamycin Target Eluting Coronary Stent ("Firehawk") for the treatment of atherosclerotic coronary lesions in an all comers, regardless of disease complexity and co-morbidities, real world population. Firehawk™ is MicroPort's proprietary, in-house developed, third generation Drug Eluting Stent ("DES") system and the Company received CE Mark approval for the Firehawk™ in January 2015. The first patient was enrolled by Dr. Lene Holmvang, at the Copenhagen University Hospital - Rigshospitalet in Denmark.
TARGET AC is a prospective, multi-center, randomized controlled clinical trial. The study plans to enroll approximately 1,656 patients at up to 22 study sites throughout Europe including countries such as the United Kingdom, France, Spain, Italy, Belgium, the Netherlands, Poland, Germany, Austria and Denmark. Eligible patients with coronary artery disease will be randomized 1:1 to receive Firehawk™ or Abbott's Xience family of everolimus-eluting stents. The trial's primary endpoint is the target lesion failure (TLF) rate at twelve (12) months, and patients enrolled in the TARGET AC clinical trial will be followed up for up to five (5) years.
"Firehawk™ was designed to address the remaining limitations of current generation DES technology," said William Wijns, M.D., PhD, Cardiovascular Research Center, OLV Aalst, Belgium, and Principal Investigator of the study. "I am excited about its potential impact on patient care since the innovative groove design of the Firehawk™ stent system has the potential to further reduce 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."
Clinical studies have shown that durable polymer coating technology may cause inflammation in the coronary artery. The Firehawk™ stent abandons the need for a durable polymer coating technology and features instead a 100% biodegradable polyactic acid (PLA) polymer. Combined with sirolimus drug, Firehawk's biodegradable polymer and drug combination ensures a steady and constant drug release rate and complete absorption of the polymer shortly after drug elution ends at nine months. The stent itself has a proprietary design whereby tiny grooves have been etched on the outer surface of the stent. 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. Because the polymer and drug combination are contained in the grooves of Firehawk™ and not on the outer surface of the stent like conventional DES stents, the polymer coating is protected from abrasion or cracking due to crossing or re-crossing of the lesion during the procedure. Lastly, this targeted release design of Firehawk™ allows it to provide the same level of clinical efficacy as a conventional DES while offering faster and more complete vessel healing after stent implantation, which could potentially reduce the duration of post-procedure dual antiplatelet therapy.
"The launch of the TARGET AC clinical trial in Europe is a tremendous milestone for MicroPort," said Mr. Qiyi Luo, Chief Technology Officer of MicroPort, "We believe that the Firehawk™ stent is potentially the best-in-class of the next generation DES to treat patients with coronary artery disease. We look forward to expanding on the body of clinical data that is already available to support the use of Firehawk™ for patients in Europe. "
Firehawk™ received China Food and Drug Administration (CFDA) approval in January 2014 and CE Mark approval in January 2015. The Firehawk™ stent has been extensively studied in China in 1,261 patients through a comprehensive clinical program called TARGET, which includes TARGET First-in-Man ("TARGET FIM"), TARGET I RCT, TARGET I Long and TARGET II studies. These studies were required by the China FDA in order for Firehawk to obtain CFDA approval. The TARGET AC clinical trial builds upon the TARGET series study program. The Optical Coherence Tomography (OCT) data from the TARGET FIM trial demonstrated an early healing profile with an average of 96.2% strut coverage (new cell growth over stent struts) at four months, with a low rate of mal-apposed struts (0.1%) across the 14 stents analyzed. TARGET I RCT was a prospective, randomized trial evaluating the safety and efficacy of the Firehawk™ stent for treating patients with single de novo coronary lesions compared with the Xience V everolimus-eluting stent. TARGET I demonstrated that the Firehawk stent was non-inferior to the Xience V stent for the primary endpoint of in-stent late loss at nine months (0.13±0.24 mm vs. 0.13±0.18 mm, Pnon-inferiority <0.0001). Four-year follow-up results confirmed no definite/probable stent thrombosis and a reasonably low rate of target lesion revascularization (2.3% in Firehawk group vs. 4.0% in Xience V group, P=0.33).