FDA Approves First 'Inside the Body' Surgical Platform

Emma Hitt, PhD


May 02, 2012

May 2, 2012 — The US Food and Drug Administration (FDA) has approved the Percutaneous Surgical Set, the first surgical instrument set that can be assembled and disassembled inside the body during minimally invasive laparoscopic abdominal surgery.

"Laparoscopic surgery reduces the size and number of incisions needed to perform certain surgical procedures," noted Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health, in the FDA's written release. "The Percutaneous Surgical Set provides a novel treatment option for performing this type of abdominal procedure."

The FDA reported the marketing approval in a press release yesterday after its decision on April 30.

The Percutaneous Surgical Set is manufactured by Cincinnati-based Ethicon Endo-Surgery Inc, a subsidiary of the Johnson & Johnson Co.

The manufacturer describes the device as offering the "cosmetic benefit of needlescopic surgery and the performance of traditional laparoscopy." According to the manufacturer, this is accomplished by laparoscopically attaching a full-sized 5-mm or 10-mm instrument head to a 3-mm shaft introduced percutaneously.

"This platform is designed to enhance microlaparoscopic, single-site laparoscopic and hybrid natural orifice transluminal endoscopic surgery (NOTES) surgical approaches," the manufacturer adds.

The FDA approved the new device through the de novo classification process, which is a regulatory pathway for "low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device."

According to the FDA, the Percutaneous Surgical Set represents the fourth device granted a de novo petition this year.

The petition was granted on the basis of data demonstrating that the "device functions as intended, and is properly sized for laparoscopic abdominal surgery, and surgeons can apply enough force to grasp and manipulate soft tissue."

Clinical studies have also evaluated the ability of surgeons to assemble and disassemble the device inside the abdomen, device failures and risks, and how to address risks.

The device is indicated for use in abdominal surgery only. The FDA notes that risks associated with the device include failure of the device, user error, abdominal cavity damage, infection, and tissue inflammation.