Device Dossier

Progel Platinum Surgical Sealant - Applicator, surgical sealant, dual-channel

Device Dossier for Progel Platinum Surgical Sealant - Applicator, surgical sealant, dual-channel (Applicator, surgical sealant, dual-channel, Class III,…

Intended purpose

The Progel Platinum Surgical Sealant is a single use device intended for application to visible air leaks on the visceral pleura after standard visceral pleural closure techniques have been employed during resection of lung parenchyma.

Functional description

Progel Platinum is a single-use medical device that is formed as a result of mixing two components: (1) a solution of recombinant Human Albumin (rHA) derived from yeast and (2) a synthetic crosslinking component of polyethylene glycol(PEG) that is functionalized with succinate groups. Upon mixing, a clear, flexible hydrogel is formed. As Progel Platinum degrades it is metabolized and virtually all cleared primarily through the kidneys within 14 days.

TGA Public Summary