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Blockbuster News: Warm Congrats Sent to MemoLefort LAA Closure Occluder I for Winning Over National Class-three Registration Certificate for Medical Apparatus

2020-06-09

On June 9, 2020, the 'LAA Closure Occluder I' (Trade Name: MemoLefort LAA Closure Occluder I) developed and produced by Shanghai Shape Memory Alloy Material Co., Ltd. (hereinafter referred to as 'SHSMA'), a wholly-owned subsidiary of Lepu Medical, officially won over national class-three registration certificate for aedical Apparatus (National Machinery Registration Standard 20203130560). Launching of MemoLefort LAA closure occluder marks continuous optimization of the company’s business structure, and a major step of its development strategy converted from the previous inborn cardiac disease market to structure market.

 

From the website of National Medical Products Administration

 

Safe and Stable

A Secured Option for Patients with Atrial Fibrillation

 

 

MemoLefort LAA closure occluder applies internal plug design that is supported by a shape memory alloy nickel-titanium skeleton. It shows sound radial support and outstanding compliance, and can be used for most LAA structures. The micron-level baffle coating can effectively block blood flow, and the integrated barb on edge of the occluder makes sure that the instrument is stable in LAA after release.

 

Results of clinical trials of MemoLefort LAA closure occluder I showed that LAA closure rate was 97.6%12 months after surgery, and the ischemic stroke rate was 0% within 12 months, an indicator that for patients with non-valvular atrial fibrillation who are not suitable for long-term use of anticoagulant drugs, implantation of MemoLefort LAA closure occluder can effectively reduce risk of stroke and thus enjoyed high safety. It can be widely used in clinical operation.

 

Closure at the source

New option for stroke prevention

China is home to a tally of 10 million patients with atrial fibrillation and sees a rising incidence rate with progress of the aging society. Risk of stroke in patients with atrial fibrillation is five folds that of common people, so it has been widely acknowledged by all walks of the society on the need for stroke risk control and thrombus management in patients with atrial fibrillation. Among patients with non-valvular atrial fibrillation, more than 90% of thrombus is originated from LAA, so implementation of LAA closure can, to a certain degree, bring down probability of stroke in patients with atrial fibrillation.

 

MemoLefort LAA closure occluder I is implanted to the LAA. It is safe and stable and does not affect tissues around the atrial appendage, and would thus occlude thrombosis from the source, and hence realize the goal of preventing thrombosis and stroke without long-term use of anticoagulants. It helps drastically boost living quality of patients.

 

 

Eyeing the Future and Taking Root at the Present

Performing the Mission of Medical Apparatus

SHSMA has always been insisting on the corporate purpose of ‘caring for life with science and technology’ of Lepu Medical, its headquarter company.By focusing on technological innovation, and prioritizing construction of independent intellectual property rights, it has been constantly enhancing input to research and development.. For now, the third-generation oxide-coating single-rivet ASD occluder has been granted approval to be put in the market in China in May 2020, and the fourth-generation degradable occluder is also going through its clinical trials. Lepu Medical has never ceased to adjust its strategic positioning in its development process to cater to market needs. Approved launching of the MemoLefort LAA closure occluder I marks expansion and leap of SHSMA’s assembly line from inborn cardiac disease field to the structural field. It also signifies that more patients with cardiovascular diseases will get blessed from products and services provided by Lepu Medical. SHSMA is to continue to live up to clinical needs as its core,  optimize product structure, and make endeavors to provide patients with safer and more effective medical solutions.



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