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 theÂ peritoneum will provide roughly 8 mm fascial bites with the suture passer onÂ either side of the laparoscopic portÂ site. The blue stripe on the CrossBow should always beÂ below the skin, especially on thin patients, so as to avoid puncturing the skinÂ with the suture passer. An Adaptor may be required for defects larger thanÂ 10 mm in diameter.
Patients with dilated port sites from specimenÂ extraction may not benefit from the simple closure afforded by the CrossBowÂ system. This can be overcomeÂ with sliding the CrossBow system along the fascialÂ defect and deploying multiple interrupted sutures prior to throwing knots. AÂ special Adaptor (which bringsÂ the device outer diameter to 18.5 mm, similar toÂ 15 mm trocar) may be required to maintain pneumoperiotneum in such cases.Â Alternatively the device canÂ be rotated 90 degrees to simulate a figure ofÂ eight closure with two independent single sutures. Again, no knots should beÂ thrown until all sutures are inÂ place.
The device is contraindicated in patients in whom laparoscopic/robotic surgery is contraindicated. Low BMI patients may not have adequate distanceÂ between the skin and fascia to both avoid dermal punctures and achieve adequateÂ fascial bites.