Atrial Septal Defect Clinical Trial
Official title:
Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
Atrial Septal Defect (hereinafter referred to as "ASD") is a common congenital heart disease
(hereinafter referred to as "CHD"), accounting for about 10% of CHD in children.Initially，ASD
was treated by surgical operation. Nowdays transcatheter ASD closure, characterized by
minimal invasion, definite curative effect, short recovery period, and no need for
cardiopulmonary bypass, provides a new safe and effective therapy for CHD. According to a
large number of clinical reports, the use of transcatheter closure devices for ASD closure
has a high success rate, good closure effect and low risk of complications.
Absnow absorbable ASD closure system has undergone implantation experiments that implant it
into animal (pig) ASD models, with the implantation success rate being 100%. Up to 2 years'
observation indicated that the cardiomyocytes and endothelial cells covering the implanted
device were not different from those of the control group (nickel-titanium alloy occluder)
and were of a great number, and the inflammatory response was remarkably lower than that of
the control group. During the observation period, all occluders in the trial did not fall off
or were displaced, no evident postoperative complications and therefore, this occluder has
the feasibility of local application and system safety.
Absnow absorbable ASD closure system developed by LifeTech Scientific passed the registration
inspection of CFDA Shenzhen Medical Device Quality Monitoring and Inspection Center,
verifying that this closure system conforms to the product technical specification in
mechanical strength, physiochemical properties and biological properties. According to the
provisions in Measures for Administration of Medical Device Registration (No. 4 Order) and
Regulation on Quality Management of Medical Device Clinical Trial (No. 25) issued by CFDA,
this product has the conditions for clinical trial.
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