PSDV advantage

Reduced risk of staple line bleeding and leaks

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix is an acellular, non-crosslinked biologic buttress developed to improve staple line integrity that has been shown to:

  • Reduce staple line bleeding1* with less need for hemostatic clips
  • Reduce the occurrence of postoperative bleeding2,3
  • Reduce leak risk4,5*

Uniquely manufactured

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix is created from a proprietary tissue manufacturing technique that is designed to provide high levels of biocompatibility (based on histological features6*) while maintaining the intrinsic suppleness and strength of the material.7*

  • Delivers an acellular, non-cross-linked collagen matrix that is immunologically inert7*
  • Product is derived from bovine pericardium and processed during manufacturing to produce a biocompatible, accelular collagen matrix8

*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. AS-0012R. Synovis Surgical Innovations.
  2. D’Ugo S, Gentileschi P, Benavoli D, et al. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2013 Nov 12.
  3. Stamou KM, Menenakos E, Dardamanis D, et al. Prospective comparative study of the efficacy of staple line reinforcement in laparoscopic sleeve gastrectomy. Surg Endosc. 2011;25(11):3526-3530.
  4. Shikora SA, Kim JJ, Tarnoff ME. Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2008;4(6):729-734.
  5. 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.
  6. Deeken C, Melman L, Jenkins E, Greco S, Frisella M, Matthews B. Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair. J Am Coll Surg. 2011;212(5):880-888.
  7. Oray BN, Kelly S, Konobeck T, Lambert A, Mooradian DL. Novel propylene oxide-treated bovine pericardium as soft tissue repair material and potential scaffold for tissue engeineering. Surgical Technology International XVIII. 6.
  8. Data on file. Baxter Healthcare Inc.