Kuala Lumpur, Malaysia - On April 21, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") signed a memorandum of understanding ("MOU") with the Ministry of Health of Malaysia and announced that the two parties will launch the TARGET MALAYSIA REGISTRY for MicroPort®'s in-house developed Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). The Deputy Minister of Malaysia Ministry of Health YB Dato' Seri Dr Hilmi bin Yahaya, CEO of Secretariat for the Advancement of Malaysian entrepreneurs Mr. Neil Foo, MicroPort® First Vice President of International Business Dr. Linda Lin and MicroPort® Vice President of Clinical Science and Medical Affairs Ming Zheng attended the signing ceremony.
TARGET MALAYSIA REGISTRY is a perspective, multi-center, single arm clinical trial, designed to further assess the safety and efficacy of Firehawk® in a real world population. It is planned to enroll a total of 1,200 patients in this trial and all of them will be implanted in Firehawk®. The clinical trial's primary endpoint is the target lesion failure ("TLF") rate at 12 months and patients will be followed up for one-year post study enrollment.
During the signing ceremony, Mr. Neil Foo, CEO of Secretariat for the Advancement of Malaysian entrepreneurs representing YB Dato' Seri Dr Ir Wee Ka Siong, Malaysia Minister of Prime Minister Department, addressed a speech extending congratulations on the official launch of the TARGET MALAYSIA REGISTRY clinical program. He noted, with the advancement of the "One Belt, One Road Initiative," the relationship between Malaysia and China is getting closer and both governments encourage Chinese enterprises to invest in Malaysia. He said, the diversified culture of Malaysia makes it the best partner of China in its "One Belt, One Road Initiative," and the TARGET MALAYSIA REGISTRY program will pave the way for future investment and cooperation programs in the medical and healthcare industries between the two parties.
Malaysia is an important partner of China's "One Belt, One Road Initiative," with over 30 million population and huge demand for cardiovascular devices. The Deputy Minister of Malaysia Ministry of Health YB Dato'Seri Dr Hilmi bin Yahaya said, the launch of TARGET MALAYSIA REGISTRY 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, and thereby helps it to provide better service for local patients.
The revolutionary third-generation DES Firehawk® is the result of eight years of research and development of MicroPort® and it is the world's first and only target eluting stent. As the world's lowest drug dosage stent, Firehawk® combines the merits of the bare metal stent and DES. It adopts unique in-groove abluminal coating design and target-eluting technique, which allow Firehawk® to achieve the same clinical efficacy with significantly low drug loading, benefiting vascular early healing. YB Dato' Seri Dr Hilmi bin Yahaya said, 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.
Dr. Linda Lin, First Vice President of MicroPort® International Business, said: "MicroPort® will continue to explore markets in countries involving in the 'One Belt, One Road Initiative,' and closely work with our Malaysian distributor Emedhealth in the clinical program of the cardiovascular industry. With the support of an increasingly more clinical data, we hope Firehawk® will benefit more patients in Malaysia and the whole world."