EnPlace™ has been cleared by the FDA and is a device indicated for attaching sutures to ligaments of the pelvic floor. EnPlace is not a procedure. The EnPlace system is intended for use only by physicians with appropriate training and experience. This animation is being provided for educational and informational purposes only and should not be considered medical advice and is not intended to replace the independent professional medical judgment of a licensed physician with respect to particular patients, procedures, or practices.
EnPlace is a single-use only product and should never be re-sterilized. Each device should be carefully examined prior to surgery and monitored during the surgical procedure to ensure proper device function. The device should only be used in a patient if a physician determines the individual is an appropriate surgical candidate.
EnPlace is a nitinol-based anchor and is contraindicated for patients with known allergy to nickel.
Potential adverse reactions with EnPlace include: vessels and / or nerves, bowel and urinary tract injury; temporary irritation of surrounding tissue and / or foreign body reaction; pain, fistula formation.
