The Food and Drug Administration has granted 510K clearance to Gore Medical for a new biomaterial for hernia repair, according to a Gore statement.
Gore describes the product – GORE SYNECOR Biomaterial – as having a “unique structure,” which prevents surgeons from having to choose between using a “permanent material” and an “absorbable, nonpermanent material” when deciding which biomaterial to use for a hernia repair.
GORE SYNECOR Biomaterial is composed of the following:
• Dense monofilament polytetrafluoroethylene macroporous knit.
• GORE BIO-A Web, “a tissue scaffold with proven outcomes in contaminated hernia repair. providing rapid vascularization and ingrowth in complex repairs.”
• Nonporous PGA/TMC film.
No precertification is required for surgeons to implant GORE SYNECOR Biomaterial.
For more information about the new product, visit www.goremedical.com.