GORE® SYNECOR Biomaterial is not authorized for use in Canada.
Designed for Intraperitoneal* and Preperitoneal† Placement
Prospective Study (SYN 20-01) in Progress1
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.
* GORE® SYNECOR Intraperitoneal Biomaterial.
† GORE® SYNECOR Preperitoneal Biomaterial.
- 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
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INDICATIONS FOR USE: The GORE® SYNECOR Intraperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Intraperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.
INDICATIONS FOR USE: The GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Preperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.