Device Dossier

Corolene - Suture, polypropylene monofilament

Device Dossier for Corolene - Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class III, sponsor Device Technologies).…

Intended purpose

Corolene sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery.

Functional description

The synthetic non-absorbable surgical sutures Corolene are composed of an isotactic polypropylene monofilament, with or without pledget of different sizes. Corolene sutures elicit a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Corolene sutures are not absorbed and there is no degradation or loss of strength. The stainless steel needle is available in silver colour or extrablack colour.

TGA Public Summary