Author: Kate Lak, MD
New Wave Endosurgery received FDA approval for the M-Close Kit in 2005.
The M-Close Kit combines a port closure device with a mechanism for targeted injection of local anesthetic. The device is deployed through a laparoscopic port and a set of needles is used to inject local anesthetic, then penetrate the fascia for port site closure. The M-Close Kit uses a standardized measurement from the peritoneum rather than the skin, allowing for a reproducible targeted infusion of local anesthetic for rectus sheath block.
Port closure is achieved by passing a guidewire and then suture 1 cm from the fascial edges. The device uses standard sutures; multiple sutures may be used to close wider defects. The needles through which the suture is passed are guarded from intra-abdominal injury, allowing for port closure without pneumoperitoneum.
No clinical testing was required for this device as it was determined to be substantially equivalent to the predicate devices: Blunt Nerve Block Needle (Epimed International, Johnstown, NY), Pajunk Anesthesia Conduction Needle (Pajunk Medical Technology, Geisingen, Germany) and the Plexolong Set (Pajunk Medical Technology, Geisingen, Germany).
The M-close kit is indicated for port site closure and the targeted delivery of local anesthetic at incision sites for laparoscopic and robotic surgical cases.
Allergy to local anesthetic medication.