PSDV advantage

Strong from the start

In a study looking at the tensile strength of PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix and SEAMGUARD material, measurements were taken prior to incubation in sterile saline. PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix was shown to provide significantly greater strength out of the package.1*


Twice the Mean Tensile Strength

An experimental study evaluating staple line seam integrity at supraphysiologic intraluminal pressures in the immediate postoperative period with a canine model demonstrated:

  • Higher bursting pressures with buttressed ileocolic anastomoses than nonbuttressed ileocolic anastomoses regardless of the operative technique2*
  • Buttressed anastomoses never ruptured at the staple line2*

Higher Mean Burst Pressure

Strong over time

Samples of PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix and SEAMGUARD material were placed in sterile saline and incubated at 37°C for 0, 7, 14, 21, or 28 days. The study showed no significant decrease in tensile strength over time with PERI-STRIPS DRY Staple Line Reinforcement with VERITAS.1*

  • After 7 days in sterile saline at 37°C, both buttress materials showed no statistically significant change in tensile strength
  • However, there was a significant decrease in tensile strength of the SEAMGUARD material between day 7 and day 14 and thereafter

Mean Tensile Strength Over Time
Day 14 Tensile Strength
Day 28 Tensile Strength

*Pre-clinical data results may not correlate to results in humans.

View Detailed Important Risk Information »

PERI-STRIPS DRY with VERITAS Collagen Matrix Staple Line Reinforcement (PSDV)

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

  1. Data on file. SI-0107. Synovis Surgical Innovations.
  2. Gaertner WB, Hagerman GF, Potter MJ, Karulf RE. Experimental evaluation of a bovine pericardium-derived collagen matrix buttress in ileocolic and colon anastomoses. J Biomed Mater Res B Appl Biomater. 2010;92(1):48-54.