USGI Medical's (San Clemente, California) Incisionless Operating Platform (IOP) could become the device of choice for surgeons seeking to correct a failed vertical banded gastroplasty.
The IOP has been used for procedures designed to reduce the size of the stomach pouch and opening to the small intestine in patients who developed pouch or stoma dilatation post-Roux en Y gastric bypass (RYGB).
To perform these surgeries a small flexible endoscope and an IOP are used. The devices go entirely through the patient's mouth. The IOP tools are used to grasp tissue and deploy suture anchors to create multiple tissue folds in the stomach pouch, allowing the surgeon to reduce the volume to more closely match original VBG proportions.
The procedure is similar to ROSE (Revision Obesity Surgery, Endolumenal), a procedure to "tune up" the anatomy in roux-en-Y gastric bypass patients who've started regaining weight.
"Basically what the device allows us to do is endoscopically go down and arrange some tissue fasteners (pleats) in the stomach pouch," Dr. Peter Henderson MD, of Georgia Coast Surgical (Brunswick, New Jersey), told Biomedical Business & Technology. The really nice thing about this whole approach, you're able to do this without entering the abdominal cavity . . . all done endoluminally. Patients can go home to the same day; they don't have a lot they have to heal up from."
Henderson added that by eliminating skin incisions and the tedious dissection of scar tissue in the abdomen, this new incisionless approach reduces the risk of a traditional VBG revision.
IOP was developed in house and received FDA approval in 2007. The device is currently in the process of receiving CE-mark approval in Europe. It could possibly receive this approval in six months, the company said.
Here's how the device works:
Combining the incisionless nature of endoscopy with the therapeutic benefit of laparoscopy, the IOP delivers USGI's expandable tissue anchors. These anchors were designed to address the challenges of endolumenal wound closure. The expandable tissue anchors spread forces to allow improved tissue healing and surgical feel while tensioning the sutures.
To date the device has received a great amount of publicity and is gaining traction. IOP was featured in three podium sessions at the recent Society of American Gastroenterological and Endoscopic Surgeons (SAGES; Los Angeles) scientific session in Phoenix.
Surgical teams at UC San Diego, Legacy Health System (Portland, Oregon) and Hospital Bocalandro (Buenos Aires, Argentina) used the IOP to perform multiple common surgical procedures using four separate incisionless surgical approaches.
Surgeons also have used the IOP to perform nine cholecystectomies (gall bladder surgeries), two appendectomies; and 18 endolumenal gastric pouch and stoma reductions in post-Roux-En-Y gastric bypass (RYGB) patients.
Elsewhere in the product pipeline:
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