PSDV advantage

Meta-analysis results for gastric staple line reinforcement

Over 18 years and 2.2 million implants later, PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix / PERI-STRIPS DRY Staple Line Reinforcement continue to have a proven clinical history.1,2*

The largest meta-analysis to date evaluating the outcomes for gastric staple line reinforcement was conducted through a systematic review of medical literature from 2000-2013 to:

  • Provide evidence on the relative efficacy of gastric staple line reinforcement (SLR)
  • Compare rates of effectiveness of three commonly used SLR methods to "no reinforcement"

Data was extracted on 56,309 patients for leak and 41,864 patients for bleeding, with 66,727 unique patients in the analysis. These patients were included in 516 study arms, 301 for leak and 215 for bleed.

  • 43,831 (over 40%) of the patients did not have SLR of any type
  • 34,123 (34.8%) were oversutured
  • 13,597 (13.9%) used PERI‑STRIPS DRY Staple Line Reinforcement / PERI‑STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix (PSDV)
  • 6,622 (6.7%) used SEAMGUARD Bioabsorbable Staple Line Reinforcement

Study overview

A total of 16,967 articles were screened and 295 studies were retained for data extraction.

Study exclusion criteria included meta-analysis, reviews, case reports, letters to the editor, studies with less than 5 patients, animal studies, non-English publications, open surgery, bariatric surgeries other than sleeve gastrectomy or gastric bypass, duplicate studies, population level studies, and studies where complications failed to be reported and where only a very high risk group such as revisions were reported.

Study Overview

Reinforcement type affects leak rate

The incidence of gastrointestinal staple line leaks was highest for the patients who had no buttressing and lowest for the patients with PERI‑STRIPS Staple Line Reinforcement / PERI‑STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix.

Reinforcement type affects leak rate

Reinforcement type affects bleed rate

The highest incidence of bleeding was seen when there was no reinforcement of the staple lines, while the lowest was reported for the gastrointestinal staple lines buttressed with PERI‑STRIPS Staple Line Reinforcement / PERI‑STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix.

Reinforcement type affects bleed rate

Reinforcing gastrointestinal staple lines reduces complications

This study shows that staple line reinforcement makes a difference:

  • The incidence of staple line leaks or bleeds was highest for the patients who had no SLR
  • The lowest incidence of staple line leaks or bleeds was seen with PERI‑STRIPS DRY Staple Line Reinforcement / PERI‑STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix

This large meta-analysis demonstrated that in a population predominantly comprised of morbidly obese bariatric patients, excluding high risk revision patients, gastrointestinal staple line reinforcement significantly reduced the likelihood of staple line leaking and bleeding.

This meta-data analysis reported that PERI‑STRIPS DRY Staple Line Reinforcement / PERI‑STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix (bovine pericardium) outperformed no staple line reinforcement, suture oversewing and synthetic buttress, and SEAMGUARD Bioabsorbable Suture Line Reinforcement.

*PERI-STRIPS DRY has been superseded by PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix.

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. Baxter Data on File (1997-2015)
  2. Shikora SA, Mahoney CB.  Clinical benefit of gastric staple line reinforcement (SLR) in gastrointestinal surgery: a meta-analysis.  Obes Surg.  2015;25(7):1133-1141.