Device Dossier
PTFE Polymer Pledgets - Prosthesis, internal, intracardiac, patch
Device Dossier for PTFE Polymer Pledgets - Prosthesis, internal, intracardiac, patch (Cardiovascular patch, synthetic, Class III, sponsor Medtronic).…
- GMDN category: Cardiovascular patch, synthetic
Intended purpose
PTFE pledgets are indicated for use as non-absorbable suture buttresses when there is a possibility of sutures tearing through the tissue. These pledgets are used in various surgical procedures such as vascular closure, septal repair, myocardial closure, valvular suturing and hepatic repair.
Functional description
PTFE pledgets elicit a minimal acute inflammatory reaction in tissues powered by gradual encapsulation of the fabric by fibrous connective tissue. PTFE pledget is not absorbed nor is any significant change in tensile strength retention known to occur in vivo. PTFE Pledgets are available pre-punched.