Kuala Lumpur, Malaysia – On May 17, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") announced the enrollment of the first patient for the clinical trial TARGET MALAYSIA REGISTRY ("TARGET MR") jointly launched by MicroPort® and the Ministry of Health of Malaysia. As one part of the TARGET series studies, TARGET MR is another large-scale overseas clinical study for Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") following TARGET All Comer trial in Europe. The first patient was enrolled by Dr. Voon in Pusat Jantung Sarawak Hospital.
TARGET MR is a large-scale, perspective, multi-center, single-arm observational registry trial, jointly launched by MicroPort® and the Ministry of Health of Malaysia. It is planned to enroll a total of 1,153 patients in 10 sites of Malaysia within one year. All of the patients will be implanted in Firehawk®, and the clinical trial's primary endpoint is the target lesion failure ("TLF") rate at 12 months.
"The launch of TARGET MR clinical trial will facilitate the ministry to dive into the morbidity of patients with cardiovascular diseases, which is expected to provide great insight for the cardiac branch of Malaysia's Ministry of Health," said the Deputy Minister of Malaysia Ministry of Health YB Dato'Seri Dr Hilmi bin Yahaya. "The Malaysian government always aims to provide free or low-cost medical service for citizens and thus it prefers cost-effective medical products such as Firehawk® which guarantees effective and high-quality medical service to benefit local citizens and communities."
"The successful enrollment of the first patient in TARGET MR trial marks a big step forward in Firehawk®’s overseas evidence-based evaluation process," said Dr. Ming Zheng, Vice President of MicroPort® Clinical Science & Medical Affairs. "By TARGET MR trial, MicroPort® hopes to further assess and seek for more evidence for the safety and efficacy of Firehawk® in a real world population."
On the same day of the first patient enrollment, MicroPort® released the three-month Optical Computerized Tomography ("OCT") data from the TARGET All Comer trial of Firehawk® at EuroPCR in Paris. "Firehawk® is well suited for treatment of complex lesion subsets," said William Wijns, M.D., PhD, National University of Ireland Galway, Ireland, and the principal investigator for the trial. "I am very pleased that the TARGET All Comer trial OCT sub-study three-month data demonstrated quick and optimal vessel healing. It has potential positive impact on patient care since the innovative groove design and the absorbable polymer of Firehawk® 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."