Overview

This document presents the technical details and specifications of the MemoCarna Oxide Film Single Hub Series Occluders, designed for cardiac defect closures including Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), and Patent Ductus Arteriosus (PDA). The devices feature advanced oxide film surface treatment and a single hub design to improve biocompatibility, reduce complications, and enhance procedural outcomes.

Key Features and Innovations

• Single Hub Design: Unlike traditional double hub occluders, the left disk has no hub, resulting in a flatter surface that facilitates endothelial cell adhesion and reduces thrombosis risk. This design reduces device weight by approximately 25% and lowers overall height by 4mm, minimizing intracardiac volume impact and heart load, especially beneficial for pediatric patients.
• Oxide Film Surface Treatment: The nickel-titanium alloy wire undergoes a precise surface treatment forming a uniform, dense oxide film that removes impurities and significantly reduces nickel ion precipitation by about 46%, enhancing biocompatibility and promoting faster endothelialization.
• Datura-Shaped Braiding: The left disk features a datura-shaped hollow braided pattern that maintains mesh elasticity and stability while allowing room for late atrial septal puncture in ASDO patients.
• Improved Clamping and Occlusion Performance: The single hub ASD occluder maintains clamping force equivalent to traditional double hub devices, ensuring secure and safe occlusion.
• Compatibility with Smaller Introducers: The VSD and PDA occluders demonstrate improved introducer passage performance, allowing use of smaller introducers, reducing vascular damage and making them more suitable for pediatric patients.
• Enhanced Choke Film for PDA Occluder: The upgraded choke film increases water permeability resistance by approximately 180%, improving immediate blood blocking effect and reducing residual shunt occurrence.
• MRI Compatibility: All products are suitable for MRI scanning under static magnetic fields of 1.5T or 3T with spatial gradient fields ≤10T/m.

Technical Specifications

ASD Occluder

• Single hub design with datura-shaped hollow pattern on left disk.
• Flatter disk surface post-release for better endothelialization.
• Maintains clamping force comparable to traditional double hub devices.

VSD Occluder

• Left disk without hubs, softer surface reduces risk of atrioventricular block.
• 27 models covering diameters from 4mm to 40mm with detailed dimensions for outer disks, waist diameter, and height.
• Average compressive force between disks reduced by 65.87% compared to traditional devices.
• Compatible with smaller introducers (4F to 8F) for pediatric use.

PDA Occluder

• Single hub design with flat umbrella surface at aortic end, lowering height by 4mm to avoid affecting aortic blood flow.
• 18 cylindrical models fitting tubular PDA structures and 15 models for conical PDA structures.
• Improved choke film with 180% increased water permeability resistance for better immediate occlusion.
• Compatible with smaller introducers (5F to 10F), suitable for pediatric patients.

Performance and Safety Data

• Animal and human in vitro studies confirm significant reduction in nickel ion release, enhancing biocompatibility.
• Endothelialization observed within 3 months post-surgery with improved surface cell adhesion compared to traditional NiTi double hub occluders.
• Clamping force tests show equivalence between single hub and traditional double hub ASD occluders.
• Compressive force between disks in VSD occluders significantly reduced, lowering mechanical stress on cardiac tissue.

Recommendations and Usage

• Devices are recommended for use in pediatric and adult patients requiring closure of ASD, VSD, or PDA defects.
• MRI scanning is safe under specified conditions (1.5T or 3T static magnetic field, spatial gradient ≤10T/m).
• Selection of device size and introducer compatibility should be based on patient anatomy and defect dimensions.

Conclusion

The MemoCarna Oxide Film Single Hub Series Occluders represent a significant advancement in cardiac occlusion devices by combining innovative design features such as single hub construction, oxide film surface treatment, and improved mechanical properties. These enhancements contribute to safer implantation, reduced complications, better biocompatibility, and suitability for pediatric patients.