Risk factors and comorbidities may impact healing

GORE® SYNECOR Biomaterial

GORE® SYNECOR Intraperitoneal Biomaterial Clinical Data Summary1

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DATA SUMMARY:

Long-term follow-up:

  • 32 months mean (14-53 months range)
  • Patients: 459
  • Intraperitoneal placement: 76%
    • Bridging repair: 57%
  • Laparoscopic and robotic approaches: 95%
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QUALITY OUTCOMES:

  • Hernia recurrence:
    • 0.9% clinically confirmed hernia recurrence (4/459 patients, mean 32 months)
      (data       on file 2022; W. L. Gore & Associates, Inc; Flagstaff, AZ.)
  • Seroma: 0% (12 months)
  • Surgical site infection (SSI): 2% (12 months)
  • Surgical site occurrence requiring procedural intervention (SSOPI): <3% (24 months)
  • Adhesion formation: 0% (12 months)
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PATIENT CHARACTERISTICS:

  • Mean body mass index (BMI): > 33 kg/m2
    • Obese: 63%
  • Diabetes mellitus: 20%
  • Tobacco users: 9%
    • Current users: 19%
    • Former users: 32%
  • Ventral hernia working group (VHWG) classification
    • Grade 1: 23%
  • Grade 2: 77%

GORE® SYNECOR Preperitoneal Biomaterial Clinical Data Summary2-6

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DATA SUMMARY:

Long-term follow-up:

  • 30 days to 2.1 years
  • Patients: 298
  • Robotic, laparoscopic and open approach
  • Retromuscular repairs including totally extraperitoneal (TEP) and transversus abdominis muscle release (TAR) including bridging
  • Preperitoneal placement
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QUALITY OUTCOMES:

  • Hernia recurrence: 0–4.5%
  • Seroma: 4.5–15%
  • Surgical site infection (SSI): 0–10%
  • Surgical site occurrence requiring procedural intervention (SSOPI): 0–10%
  • Complete mesh removals: ZERO
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PATIENT CHARACTERISTICS:

  • Mean body mass index (BMI): > 30 kg/m2
  • Diabetes mellitus
  • Tobacco users
  • Immunosuppressed
  • History of wound infections
  • Recurrent hernias

Prospective Study (SYN 20-01) in Progress7

Assessment of GORE® SYNECOR Biomaterial in focused Patient Populations and Long-Term Application

  • Sponsor: W. L. Gore & Associates, Inc.
  • Brief summary: The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral/incisional hernia amenable to hernia mesh repair will be enrolled into 2 cohorts (U.S. and EU) and followed-up over the period of 60 months.
  • Conditions: Hernia ventral, Hernia incisional, Hernia incisional ventral.
  • Enrollment: 320 anticipated.
  • 2 groups/cohorts.

Clinical Trials >

Today’s high-risk patients need more from you. Give them more with GORE® SYNECOR Biomaterial.

  1. Doerhoff C, Grantham D, Mallico E, Washington R, Linn J. Long-term outcomes following hybrid biomaterial repair of ventral hernias: a multicenter, retrospective study. Presented at the EHS-AHS Joint Congress 2021; October 13-16, 2021; Copenhagen, Denmark. British Journal of Surgery 2021;108(8)Supplement:viii42. PO90.
  2. Lighter M, Roberts J. The role of biosynthetic mesh in abdominal wall hernia repair in the setting of obesity, recurrence and high risk patients. Presented at the 2019 AHS Annual Meeting; March 11-14, 2019; Las Vegas, NV. Hernia 2019;23(Supplement 1):S96-S97. P-1256.
  3. Landry M, Grimesly L, Gorman B, et al. Clinical Quality Improvement (CQI): evaluating the real work use of a new hybrid hernia mesh. Presented at the 2018 International Hernia Congress Program; March 12, 2018; Miami Beach, FL.
  4. Rios-Diaz A, Hitchner M, Christopher AN, Broach R, Cunning JR, Fischer JP. Early clinical and patient-reported outcomes of a new hybrid mesh for incisional hernia repair. Journal of Surgical Research 2021;265:49-59.
  5. Kudsi OY, Gokcal F. Lateral approach totally extraperitoneal (TEP) robotic retromuscular ventral hernia repair. Hernia 2021;25(1):211-222.
  6. Kudsi OY, Chang K, Bou-Ayash N, Gokcal F. Hybrid robotic hernia repair for incisional hernias: perioperative and patient-reported outcomes. Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A. 2021;31(5):570-578.
  7. W. L. Gore & Associates. Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application. NLM Identifier: NCT05094089. Published October 26, 2021. Updated July 5, 2022. Accessed October 10, 2022. https://clinicaltrials.gov/ct2/show/NCT05094089

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