GORE® SYNECOR Preperitoneal Biomaterial
Tri-layer hybrid solution:
GORE® SYNECOR Preperitoneal Biomaterial offers a tri-layer hybrid solution that is designed to remain strong over the lifetime of the repair and to support a single, effective repair in complex hernia patients (Ventral Hernia Working Group (VHWG) Grade 2).1-3
Designed for ease of use during minimally invasive (laparoscopic and robotic) and open surgical procedures.1,*
- Material is flexible and conformable.
- Material memory for easy unrolling, handling and optimal placement.
- Absorbs fluids (i.e., blood).
- No pre-soaking needed but may be dipped in sterile saline to facilitate handling.
*Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications and safety information.
Strength
Durable strength of the material helps to support robust healing.
May lower the risk of recurrence versus lightweight and midweight meshes, which may offer inadequate strength in complex patients (Ventral Hernia Working Group (VHWG) Grade 2).4-8
Rapid vascularization
The GORE 3D PGA:TMC Web Scaffold of GORE® SYNECOR Preperitoneal Biomaterial promotes cellular infiltration and rapid vascularization to aid in overall treatability and mitigate the need for device removal if infection were to occur.3,9,10
Inguinal Hernia Treatment
The large pore size of the PTFE knit mesh promotes tissue integration with minimal chronic inflammation, and along with the conformable low-profile design may result in low rates of patient reports of chronic pain at inguinal hernia repair sites.3,11
References
- W. L. Gore & Associates, Inc. GORE SYNECOR Preperitoneal Biomaterial Design Control (DC) Matrix. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2024. [Design Control Matrix – DC Matrix]. MD187124. Rev 4.
- Ventral Hernia Working Group; Breuing K, Butler CE, et al. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery 2010;148(3):544-558.
- W. L. Gore & Associates, Inc. Clinical Evaluation Report for GORE® SYNECOR Preperitoneal Biomaterial. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2024. [Clinical Evaluation Report – CER]. MD188925. Rev 2.
- W. L. Gore & Associates, Inc. Plexus Knit PQ Validation Report. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2024. [Validation Report]. MD145325. Rev 8.
- Olson TB. Competitive Hernia Device Strength Evaluation. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2016. [Work plan]. WP108484.
- Petro CC, Nahabet EH, Criss CN, et al. Central failures of lightweight monofilament polyester mesh causing hernia recurrence: a cautionary note. Hernia 2015;19(1):155-159.
- Cobb WS, Warren JA, Ewing JA, Burnikel A, Merchant M, Carbonell AM. Open retromuscular mesh repair of complex incisional hernia: predictors of wound events and recurrence. Journal of the American College of Surgeons 2015;220(4):606-613.
- Warren JA, McGrath SP, Hale AL, Ewing JA, Carbonell AM 2nd, Cobb WS 4th. Patterns of recurrence and mechanisms of failure after open ventral hernia repair with mesh. American Surgeon 2017;83(11):1275-1282.
- Crawford N. Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2016. [Final study report]. 2344TL.
- Berman A. Evaluation of Plexus with no film and ETHICON PHYSIOMESH® in a 30-day rabbit subcutaneous model. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2015. [Study protocol]. 2336SC.
- Berman A. Evaluation of Plexus without film and ETHICON PHYSIOMESH® in a 180-day rabbit subcutaneous model. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2015 [Study protocol]. 2338SC.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for markets where this product is available. RXOnly
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