Cocoon PFO Occluder

The Cocoon PFO Occluder, developed by Sahajanand Medical Technologies (SMT) and manufactured by Vascular Innovations Co., Ltd., is an advanced self-expanding, self-centring device engineered for the transcatheter closure of patent foramen ovale (PFO) defects to prevent recurrent cryptogenic strokes. Its innovative design incorporates a nitinol wire frame with a platinum nanocoating applied via nanofusion plasma deposition, ensuring biocompatibility, non-corrosive properties, and high radiopacity. The device’s recapturable and redeployable nature (when the delivery cable remains securely connected) allows for precise positioning, making it adaptable to a wide range of patient anatomies.

Material and Design:

• Nitinol wire frame with ultrathin platinum nanocoating to minimize nickel leaching and enhance radiopacity
• Self-centring double-disc structure filled with polypropylene fabric to promote thrombogenicity
• Soft rim design, over twice as soft as competitors, reducing trauma to surrounding tissues
• Recapturable and redeployable design for accurate positioning, contingent on secure delivery cable connection

Size Range and Delivery:

• Six SKUs with right atrial disc diameters from 18 mm to 35 mm and left atrial disc diameters from 18 mm to 30 mm; 3 mm waist length and 5 mm total length
• Sizing based on defect distance to aortic root or superior vena cava: CPF18 (9–12.4 mm), CPF25/CPF2525 (12.5–14.9 mm), CPF3025/CPF30 (15–17.4 mm), CPF35 (≥17.5 mm)
• Compatible with 8F sheaths (78 cm usable length) for five sizes; CPF35 requires 9F sheath
• Delivery system includes 83 cm dilator, 10–12 cm loader, and 6F delivery cable (117 cm); preclinical studies show neoendothelialization at 36–42 days