PARIS — A novel device for single-incision surgery from Applied Medical (Rancho Santa Margarita, California) made its European début at the 111th French Surgery Congress held here last week.
The GelPOINT, which won 510(k) approval from the FDA in February, goes head-to-head with single-port access (SPA) devices from Covidien (Dublin, Ireland), Olympus (Tokyo) and Karl Storz (Tuttlingen Germany).
Yet innovative features of the new Applied Medical port create advantages against these established competitors and challenge other SPA products with its unique surgical approach.
The current line of SPA devices target the umbilicus as the point of entry for scar-less surgery, so called as it requires a single incision that is later hidden in the folds of the belly button.
This contrasts with the conventional approach to minimally invasive surgery that leaves four puncture holes in the patient's abdomen required by a surgeon to triangulate graspers, scissors and the endoscope at the surgical site.
Patient demand is driving a rapid acceptance of SPA with the scar-free belly button approach.
Within two years of the technique's introduction in 2007 by Paul Curcillo, MD, of Drexel University (Philadelphia), more than 5,000 SPA procedures have been performed in the U.S. alone, rapidly expanding from cholecystectomy to diverse applications for organ removal and bariatric treatments. (Medical Device Daily, June 24, 2009)
Yet inserting multiple instruments into the three to four ports packed into a narrow SPA device leads to "sword-fighting" because the surgeon is working along the same line with all instruments and no longer can triangulate.
This instrument clash, also called the "chopsticks effect" is not unlike trying to turn a steak on the grill using two forks with your wrists tied together,
Olympus and Karl Storz responded to this challenge created by their SPA ports by designing a new line of instruments with curved handles, requiring a new level of investment in dedicated tools for single-port surgeries. (MDD, June 25, 2009)
Covidien's solution is to cross the shafts of the instruments resulting in the disorienting exercise for surgeons of watching left hand actions on the right side of the monitor and vice versa for the right hand.
Applied Medical's GelPOINT is built on the company's Alexis abdominal retractor, a flexible ring inserted through an incision as small as 1.5 cm that atraumatically expands soft tissue to expose a wider opening to a surgical site.
The GelSeal cap is placed on top of the ring creating a soft surface giving the surgeon a 360-degree working platform above the surgical site inside the abdomen into which 5 mm access ports can be placed as required to triangulate instruments.
GelPOINT also can be used at any other point on the abdomen so that single-incision surgery is not restricted to an umbilical access, though this leaves a visible scar up between 1.5 cm and 7 cm.
The GelPOINT assembly includes a stopcock valve to maintain insufflation of the patient's abdomen during surgery.
The single-use package from Applied Medical for the GelPOINT advanced access platform includes four trocars with a retaining disk on the distal tip of the cannula that stabilizes the tube once it is inserted through the GelSeal cap.
The GelSeal cap can be removed during a procedure to extract an organ.
GelPOINT became available in the U.S. in mid-September and the company has filed for CE mark approval, which Gary Johnson, President of the Surgical Group at Applied Medical told MDD he expects to receive before the end of October.
Johnson also confirmed GelPOINT is currently being investigated as an access platform for robotic surgery.
A paper published online in March, 2009 in the European Urology Journal authored by Robert Stein from the Cleveland Clinic describes the results of 11 laparoendoscopic single-site surgeries using GelPOINT with the da Vinci Surgical System from Intuitive Surgical (Sunnyvale, California).
Stein et al concluded that the Applied Medical access platform provided "adequate spacing and flexibility of port placement and acceptable access to the surgical field for the assistant, especially during procedures that require a specimen extraction incision."