Paris, France, 17 May 2023 – Today, MicroPort® announced primary endpoint data at 12 months from the SAFE PROTECT clinical trial. The results of the SAFE PROTECT trial demonstrated that patients with atrial fibrillation (AFib) at an increased risk of stroke with the AnchorMan® Left Atrial Appendage Closure (“LAAC”) device (“AnchorMan®”) showed non-inferiority results when compared to patients treated with the Watchman device manufactured by Boston Scientific. These SAFE PROTECT clinical data were presented for the first time during a late-breaking clinical trials session at the Euro-PCR conference in Paris by Dr. Ben He, who served as principal investigator together with Dr. Huimin Chu for the SAFE PROTECT trial and is the Director of Cardiology at the Shanghai Chest Hospital, China.
The SAFE PROTECT trial is a prospective, multi-center, head-to-head randomized controlled, pivotal premarket clinical trial as required by the National Medical Products Administration for approval in China. The SAFE PROTECT trial enrolled its first patient in March 2021 and completed enrollment of its last patient in September 2021. In total, there were 216 patients enrolled from 16 clinical study sites cross China. The 12-month primary endpoint was clinical success (the freedom from ischemic/ hemorrhagic stroke, systemic embolism, cardiovascular/unexplained death), and the powered secondary effectiveness endpoint was echocardiography-defined left atrial appendage (LAA) occlusion (residual jet < 5 mm). Patients enrolled in the SAFE PROTECT trial will be monitored for a duration of five years post implantation.
“The SAFE PROTECT trial is the first clinical study to show the clinical data for one-stop combined AFib ablation and LAAC in over 70% of patients who require left atrial appendage occlusion,” said Dr. Ben He. “The results not only demonstrated the excellent safety and efficacy of AnchorMan ®, but we have also shown the feasibility of one-stop combined AFib ablation and LAAC in such high-risk patients without increasing the risk of perioperative and late adverse events, including systemic embolism and device relative thrombus (DRT) etc., which is often associated with increased patient treatment cost.", he continued.
The primary endpoint of non-inferiority for the AnchorMan® LAAC device compared to the Watchman device was met with a 12-month clinical success rate in the Full-Analysis-Set (FAS) population of 98.1% versus 98.1%, difference, -0.3% [95% CI, –3.9% to 3.5%], respectively (pnon-inferiority=0.0004). No statistically significant differences in clinical success rate components were observed between the two LAAC devices. The following data were also observed low and similar between groups at 12 months post implantation for the AnchorMan® and Watchman devices, respectively: stroke (1.0% vs. 1.9%, p=1.00), systemic embolism (0.0% vs. 0.0%, p=1.00), major bleeding (BARC3-5) (2.9% vs. 1.9%, p=0.68), transient ischemic attack (TIA) (0.0% vs. 0.9%, p=1.00), device relative complications (1.0 % vs. 0.9%, p=1.00), DRT ( 3.4% vs. 3.3%, p=1.00).
The powered major secondary effectiveness endpoint of non-inferiority for the AnchorMan® compared to the Watchman device was met with an echocardiography-defined LAA occlusion rate (residual jet < 5 mm) at 12 months in the FAS population of 100% for both groups. For 12-Month Peri-Device Leak severity analysis, the AnchorMan® device results were superior at residual jet (0-3) of LAAC versus the comparator device (94.3% vs. 84.1%, p=0.049).
"We are very pleased that our AnchorMan® LAAC device met the non-inferiority primary endpoint and powered major secondary effectiveness endpoint at one year compared to the Watchman device while demonstrating excellent safety and efficacy with low rates of stroke, systemic embolism, major bleeding, TIA, device relative complications and DRT," said Dr. Qiyi Luo, the Chief Technology Officer of MicroPort®. “The remarkably high clinical success rate and low clinical adverse event rates at one year confirm the excellent outcomes associated with the innovative MicroPort® AnchorMan® design.", he continued.
The AnchorMan® device is designed to reduce the remaining limitations of current generation LAAC devices which include enhancing the safety and operability of procedures, and better sustained conformity to the anatomy of LAA. The major innovative design includes the following key features:
In addition to the SAFE PROTECT trial, MicroPort® will continue to advance the robust clinical program supporting the AnchorMan® with studies globally and studies that will explore the role of the LAAC device as a first-line therapy for stroke prevention in non-valvular AFib.
MicroPort Scientific Corporation (the "Group") is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 6 seconds in thousands of major hospitals around the world, the Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient oriented global enterprise improve and reshape patient lives through application of innovative science and technology.
About MicroPort CardioAdvent
MicroPort CardioAdvent® is a subsidiary of MicroPort Scientific Corporation. Upholding MicroPort®’s philosophy of “A brand for patients”, CardioAdvent® Medical continues to innovate and provide safe, effective and inclusive solutions to patients. The AnchorMan® LAA closure device is developed by MicroPort CardioAdvent® and is a key product in MicroPort®’s portfolio in the field of structural heart disease.
For more information, please refer to: www.microport.com.