Author(s): Allyne Topaz, MD; Luca Milone, MD
Progressive Medical Inc. received FDA notification in March 2015 regarding the Lapro-Shark being considered a Manual Surgical Instrument for General Use, a Class I type device, and therefore exempt from premarket notification [501K].
Lapro-Shark is a device manufactured by Progressive Medical Inc. to facilitate the fascial closure of trocar sites after laparoscopic surgery. It is indicated for applications in general and minimally invasive surgical procedures to close wounds and incision sites 10-15 mm in size while avoiding injury to abdominal contents.
The Lapro-Shark a disposable fascial closure device with an attached handle that distracts skin and subcutaneous fat while providing a midpoint notch to adhere the device to the fascia. The device provides two guide holes, which direct the needle and allow for guided suture placement. The needle is protected by a blunt tip on the device, preventing any entry of the actual needle into the abdominal space. The suture hole allows for guided entry of the suture through the eye of the needle, avoiding any need to capture the suture within the proper abdominal cavity.
Indicated for closure of 10-15mm incisions sites in general and minimally invasive surgical procedures.
Contraindicated in approximation of tissues under tension or cases of preexisting hernia. It is a disposable device and it cannot be re-sterilized, and is advised against in elderly, malnourished, or debilitated patients with concerns for delayed wound healing.