•  The Cocoon Septal Occluder
    
   
   
   Nanoplatinum provides superiorbio compatible properties compared to Nitinol
   
   
   Prevents Nickel leaching into the blood stream in the heart
   
   
   Prevents corosion of Nitinol wire frame in long term implants
   
   
   Platinum provides long radioopacity which enables easy positioning in the defect
   
   

Pre-Clinical Trail - Abstract
  
 
Self-Expanding Nanoplatinum-Coated Nitinol Devices for Atrial Septal Defect and Patent Ductus Arteriosus Closure:
A Swine Model

Pornthep Lertsapcharoen, M.D.*
Apichai Khongphatthanayothin, M.D.*
Vidhavas La-orkhun, M.D.*
Pentip Supachokchaiwattana, M.D.*
Phingphol Charoonrut, D.V.M.**

* Division of Pediatric Cardiology, Department of Pediatrics,
Faculty of Medicine, Chulalongkorn University
**Faculty of Veterinary Science, Mahidol University

Objectives:

Our purpose was to evaluate self-expanding Nanoplatinum-coated Nitinol devices for transcatheter closure of atrial septal defect (ASD) and patent ductus arteriosus (PDA) in a swine model. The ASD and PDA devices were braided from platinum activated Nitinol wires and filled with polyester to enhance thrombogenicity. The platinum activation of the Nitinol wires was done through the Nanofusion Technology. The coating of platinum covered the exposed surface of the Nitinol wires and prevented nickel release into the blood stream after device implantation, at the same time still maintaining the Nitinol’s shape-memory property.

Methods and Results:

ASD was created in 12 piglets by balloon dilation of patent foramen ovale. The size of ASD device was selected according to the diameter of the balloon and the created ASD size measured by transthoracic echocardiography (TTE). The ASD devices were successfully deployed in all 12 piglets under fluoroscopic guidance. Color Doppler TTE showed complete ASD closure within 15 minutes after device implantation. In the ASD cases, autopsy finding showed organizing fibrin thrombus formation and complete neoendothelialization on the outer surface of the devices within 1 week and 6 weeks after implantation, respectively.

Conclusion:

Transcatheter closure of ASD and PDA with the self-expanding Nanoplatinum-coated Nitinol devices is feasible. The excellent occlusion result and complete neoendothelialization of the devices in the swine model offers the potential for human application.