PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix is a non-crosslinked matrix designed to remodel.1*
Remodeling of PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix consists of two simultaneous processes that occur during the course of normal wound healing:1*
Although degradation is an important aspect of the remodeling process, it is a spontaneous chemical process of decomposition that is not controlled by the body.
L. MelmanTrue remodeling requires a balance between degradation of the original scaffold and the deposition of new tissue and blood vessels.3*
The acellular nature of the
Porcine model, 20x orig mag
Early signs of remodeling are evidenced by the infiltration of host cells into the
Porcine model, 40x orig mag
The
Porcine model, 40x orig mag
*Pre-clinical data results may not correlate to results in humans.
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Indications for Use
PSDV Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
(Circular reinforcement only) PSDV Reinforcement can be used for reinforcement of staple lines during gastric, bariatric, and small bowel procedures.
(Linear reinforcement only) PSDV Reinforcement can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures, and during gastric, small bowel, mesentery, colon, and colorectal procedures.
Selected Important Risk Information
Ensure the staple line is completely covered with the buttress or inadequate coverage after firing may result.
Do not get the buttress wet before applying Gel, or the buttress may not adhere to the stapler properly.
Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly.
PSD Gel Indications for Use:
PSD Gel is intended to be used only with PERI-STRIPS DRY with VERITAS Collagen Matrix (PSDV) as a temporary bonding agent during applications indicated in the PSDV Instructions for Use.
PSD Gel Contraindications:
PSD Gel is not designed, sold, or intended for use except as indicated. Use only as a temporary bonding agent with PERI-STRIPS DRY with VERITAS Collagen Matrix.
Rx Only. For more Information, please see Detailed Important Risk Information and full Instructions for Use.
References