Good News Again. MemoCarna Oxide-coating Single-rivet VSD Occluder Won Over National Class-three Registration Certificate for Medical Apparatus

On July 7, 2021, Oxide-coating single-rivet ventricular septal defect Occluder (Trade Name: MemoCarna single-rivet VSD occluder (oxide-coating)) developed by Shanghai Shape Memory Alloy Materials Co., Ltd. (hereinafter referred to as 'SHSMA') officially won over national class-three registration certificate for medical apparatus (State Machinery Registration Standard 20113130505). To date, all three new products in the oxide-coating single-rivet occluder series have been granted approval for clinical application.

(From website of National Medical Products Administration)

When compared with the traditional occluder, MemoCarna single-rivet VSD occluder (oxide-coating) has two major upgrades on single rivet design and oxide-coating surface treatment process.

MemoCarna single-rivet VSD occluder (oxide-coating) has a unique braided pattern on the left side of occluder to replace the traditional occluder's wire rivet head. After release, and moreover, the disk surface is more flattened that can bring down impact on blood flow and enhance proneness to endothelialization. Moreover, plasma surface oxidation treatment would form a uniform and dense oxide coating on surface of nickel-titanium alloy wire that would effectively lower precipitation of nickel ions and thus boost safety of closure.

Clinical trial of MemoCarna single-rivet VSD occluder (oxide-coating)’s success rate of closure was 100% after 6 months of surgery. Clinical trial results show that MemoCarna single-rivet VSD occluder (oxide-coating) enjoys a high technical success rate, sound safety, and extensive application in clinical practice.

In May 2020, the single rivet ASD occluder (oxide-coating) was approved for marketing as the first new product in this series. A year into clinical application after the market, it has been recognized among clinicians for its outstanding performance and and unique innovative dual-optimized designing. After a year, single rivet VSD and PDA occluders (oxide-coating) have both been granted approval for marketing,which brought safer and more effective options on treatment for a wide base of patients suffering congenital heart disease, and are sure to inject new vitality to the closure industry for inborn cardiac disease.

Interventional treatment of ventricular septal defect dates back to the 1990s in China, but speedy development of this method is originated from research, development and clinical application of domestic VSD occluders. Two-decade-long clinical application of self-developed domestic VSD occluders is coeval with a new historical stage in our country’s advocacy for independent innovation. As one of the first domestic enterprises to conduct research, development and production of structural heart disease apparatus, SHSMA has been catering to clinical application needs, responding to the national call on independent innovation, investing heavily in research and development, revving up its product innovation update, and always remaining committed to providing better surgical options for patients and clinical operation, all in an effort to promote sound development of the cardiovascular health course.