Salubris announced that its subsidiary Shenzhen KYD Biomedical Technology Co., Ltd. ("KYD") received approval for the LAMax LAAC® left atrial appendage closure system (Registration No.: GUO XIE ZHU ZHUN 20223130745) from National Medical Products Administration (NMPA) on June 13, 2022.
The left atrial appendage closure system with intellectual property rights is independently developed by KYD for use innonval vular atrial fibrillation patients with a CHA2DS2-VASC score ≥ 2 who are not eligible (“contraindicated”) for long-term oral anticoagulation and requir eprevention of stroke and embolism.
Epidemiology of atrial fibrillation shows that the prevalence of atrial fibrillation (age-adjusted) in China is 1.8%, and there are more than 10 million patients with atrial fibrillation in China.
The left atrial appendage (LAA), a site of predilection for thrombus formation, is the primary source of thromboemboli inpatients with nonvalvular atrial fibrillation (NVAF) who have a stroke. "Current knowledge and management of atrial fibrillation : consensus of Chinese experts 2021"issued a class I recommendation: Percutaneous left atrial appendage closure isrecommended for patients with atrial fibrillation after electrical is olation of the left atrial appendage to prevent embolic events. According to “2019 Chinese Society of Cardiology (CSC) expert consensus statement on left atrial appendage closure in the prevention of stroke in patients with atrial fibrillation”, clinical studies have confirmed that LAA closure is an effective solution toprevent thromboembolic events in atrial fibrillation and can reduce the incidence of stroke. Percutaneous left atrial appendage closure (LAAC) has become an important non-pharmacological intervention for stroke prevention inpatients with nonvalvular atrial fibrillation.
The launch of LAMax LAAC® will enrich Salubris’ device pipeline in the cardiovascular and cerebrovascular field , provide suitable device options for left atrial appendage closure, further promote the application and promotion of left atrial appendage closure, and benefit the majority of patients.
Clinical study
The LAMax LAAC® confirmatory clinical trialis a multi-center, randomized, positive controlled, parallel trial, in which the control device is the WATCHMAN left atrial appendage closure (BostonScientific, US). WATCHMAN is the world's most studied & implanted LAAC implant.
The results of the study met the primary and secondary endpoints, enriching the direct control data on the clinical effects of different closures. This clinical study, involved 13 centers across the country with 236 participants enrolled, which is currently the large stpre-marketing study of similar products in China.
Innovative structural design
❤The combination of pure nickel-titanium alloy metal materials ensures the product compatible with MRI;
❤The combination of pure nickel-titanium alloy metal materials, can improve invivo corrosion resistance;
❤Independent braided anchors, make the product retractable and stable;
❤The nut protrudes <1mm, and the nut surface is smooth, might make a low probability of device related thrombosis.
Patented modification technology
❤The innovative surface-modified polyester film in the sealing disc can reducethe risk of device related thrombosis;
❤The woven mesh disc is embedded with a non-woven dense-pored polyester film, which seals without residual leakage.
Comprehensive specification coverage
❤Equal, Normal, Plus series specification design, can adapt to a wider range of left atrial appendage sizes and anatomy;
❤ Wide range of specifications to suit more patient groups.