Author: Matthew Burstein, MD, PhD
Suture Ease received FDA approval for the CrossBow Fascial Closure System on 12/01/2017.
The CrossBow is a trocar with guide channels for a trans-fascial suture passer. The trocar has deployable snares for recovery of the intraperitoneal suture tails delivered via the suture passer. The system is used for closure of laparoscopic port sites with reliable fascial bite depths. The device also has an accessory adaptor to accommodate larger size port defects.
Premarket verification of needle penetration, snare loop integrity, needle security in passer, guide suture security, expected number of uses, and demonstration in animal models were completed as part of the 510(k) clearance with the FDA. The FDA determined that this device is substantially equivalent to the Weck EFx Fascial Closure System, K132362.
This product is intended to pass suture through soft tissue layers (fascia, muscle and peritoneum) of a trocar wound at the end of laparoscopic surgery. Using the snare tip as a landmark against the peritoneum will provide roughly 8 mm fascial bites with the suture passer on either side of the laparoscopic port site. The blue stripe on the CrossBow should always be below the skin, especially on thin patients, so as to avoid puncturing the skin with the suture passer. An Adaptor may be required for defects larger than 10 mm in diameter.
Patients with dilated port sites from specimen extraction may not benefit from the simple closure afforded by the CrossBow system. This can be overcome with sliding the CrossBow system along the fascial defect and deploying multiple interrupted sutures prior to throwing knots. A special Adaptor (which brings the device outer diameter to 18.5 mm, similar to 15 mm trocar) may be required to maintain pneumoperiotneum in such cases. Alternatively the device can be rotated 90 degrees to simulate a figure of eight closure with two independent single sutures. Again, no knots should be thrown until all sutures are in place.
The device is contraindicated in patients in whom laparoscopic/robotic surgery is contraindicated. Low BMI patients may not have adequate distance between the skin and fascia to both avoid dermal punctures and achieve adequate fascial bites.