By Jeffrey Berg
LAS VEGAS The annual meeting of the Society of Laparoscopic Surgeons (SLS; Miami) was captioned as "Minimally Invasive Surgery Week" and drew an international audience with attendees from 40 countries. The primary focus of the conference was on minimally invasive surgery (MIS) procedures that are human-driven and performed laparoscopically or robotically-assisted laparoscopy. The program featured three separate debates which reviewed the merits or drawbacks of these techniques. Each of the speakers reviewed data from comparative studies, cost analyses, surgical outcomes and speed of recovery. Despite convincing arguments that favored one MIS technique vs. the other, there was no consensus on which approach is to be favored. As the moderator noted, "there are lot of different ways to frame something. It ultimately depends on the preference of the individual surgeon." Sarah Sherwood, a spokesperson for SLS, told MDD that "it had been thought that robotics would be the easier option for MIS surgery, but it has proven not to be easy. It requires training."
The da Vinci robots from Intuitive Surgical (Sunnyvale, California) are the only robots with FDA clearance. Its first robot was introduced in 2000. The robots are used in general abdominal surgery as well as in gynecologic, urologic, cardiac, thoracic and colorectal surgeries. Intuitive's da Vinci robots have been adversely affected in the past by concerns about the device's safety, about the level of surgeon's training and by product recalls. On the other hand, the robots have been billed as a breakthrough in making surgery less invasive. With its four remote-controlled arms and sophisticated camera, it enables surgeons to operate through small incisions with great precision and visibility.
The da Vinci Xi is the company's fourth generation robot. All of the robots use an 8.5 mm diameter trocar which is unique to these robots. Mimic (Seattle) markets simulators that are used for training surgeons in operating the robots. Mimic's software is licensed to Intuitive which has multiple training centers throughout the U.S. The cost of the da Vinci Xi is about $1.8 million and the annual service contract is on the order of $150,000. The advantages of the da Vinci Xi are that it has a lighter camera, is easier to set up and has greater internal working space. Also, it is designed to be a multiquadrant access robot, whereas earlier robots work on only two quadrants. The robot has four articulating arms although most procedures use only three of these arms. In April 2014, Intuitive received 510(k) clearance for the da Vinci Sp single-port surgical system for use with an articulating 3-D HD camera.
SLS hosts Olympics for Surgeons at its annual conferences at which some of the nation's top surgeons compete for high scores using simulators that are used for training surgeons on the da Vinci robot. This event is both entertaining and educational as it provides firsthand visual evidence of the need and importance of dexterity in device manipulation.
TransEnterix (Morrisville, North Carolina) and Titan Medical (Toronto) are developing robots to compete with Intuitive Surgical. Robots that are used commercially in orthopedic and spine surgeries are marketed by MAKO Surgical (Fort Lauderdale, Florida) and Mazor Surgical Technologies (Caesarea, Israel).
Memic Innovative Surgery (Ariel, Israel) is developing proprietary technology that enables SILS (Single Incision Laparoscopic Surgery) and NOTES (Natural Orifice Translumenal Endoscopic Surgery) procedures to be performed using a mobilized and compact robotic surgical unit. Dvir Cohen, CEO, told MDD that "the main challenges in SILS and NOTES surgical procedures are limited access and lack of maneuverability. We deliver innovative, dexterous and efficient surgical robotic solutions that mimic natural control and enable new, currently unfeasible surgical procedures." Memic has completed ex vivo experiments and is moving forward with the development of its affordable robotic surgical platform for SILS and NOTES minimally invasive procedures.
Paul Allan Wetter, chairman of SLS, stressed in the conference's opening session how innovations are changing our lives. He noted that "most people on the planet have more technology in their pocket than NASA had when astronauts landed on the moon." These innovations are generating new medical apps that are transforming the way medical care is administered and that surgery is becoming less and less invasive.
Wetter explained that "this shift towards an expanded focus of the conference on minimally invasive surgery affords the opportunity to revisit its legacy as an incubator for innovation to and get back to the spirit that created this society." Approximately one-third of all surgical procedures are currently performed as MIS. The incidence is growing as new enabling technologies allow more surgeons to perform complex procedures using MIS. These new technologies need to be shown to be cost effective to payors and hospitals and to benefit the patient by being less invasive procedures that yield better outcomes.
Camran Nezhat, MD is the director of the Center for Special Minimally Invasive & Robotic Surgery at Stanford University Medical Center (Palo Alto, California). He was a pioneer in video endoscopy which has been a catalyst for inaugurating minimally invasive surgery as a surgical discipline. William Kelley, a general surgeon at Henrico Doctors Hospital (Richmond, Virginia), observed that "the single most important technological advancement for complex laparoscopic surgery is the advent of video laparoscopy." Nexhat is renown for his work in multi-organ reconstructive surgery for treating endometriosis, fibroids and infertility. The leading marketers of video endoscopic equipment in the U.S. are Olympus (Center Valley, Pennsylvania), Karl Storz Endoscopy-America (El Segundo, California) and Stryker Endoscopy (San Jose). Olympus featured its ENDOEYE FLEX 3-D articulating HD 3-D video laparoscope and its EVIS EXERA III surgical endoscopy platform that offer superior visualization.
Karl Storz highlighted its Image 1 SPIES visual enhancement tools using proprietary algorithms which includes Clara for balancing the brightness over the surgical field and Chroma for improved visibility of perfusing tissue
MicroCam, a subsidiary of Sanovas (San Rafael, California) is an emerging medical technology company that was formed to commercialize a "Plug 'N Play" micro imaging system that uses a 3 mm diameter and 5 mm long MicroCam. Larry Gerrans, CEO, explained to MDD "that the current market cannot afford the high cost of cart-based systems which take a lot of space and that the maintenance and repair cost for endoscopic imaging systems in the operating room are significant." MicroCam uses a highly integrated platform of proprietary micro optics, electronics and software systems that eliminate the need for nearly all of the components on existing cart-based endoscopic systems, such as camera consoles, camera heads, light sources, light cables and digital camera devices. This is estimated to save 80% of the cost to purchase and maintain an endoscopic imaging system. The company is going through the FDA regulatory process and plans to be on the market in 2015.
The closure of keyhole puncture wounds made with trocars having a 10 mm diameter or greater requires closure of the fascia at the port site in order to prevent possible herniation. Devices that are used for this purpose are the Carter-Thomason CloseSure system from Cooper Surgical (Trumbull, Connecticut) which uses a suture guide and suture passer, and Weck EFx from Teleflex (Research Triangle Park, North Carolina), an endofascia closure system that is designed to minimize complications of post-operative port-site herniation. In April, Teleflex partnered with Intuitive Surgical to manufacture the Weck disposable trocar seals and obturators for the new da Vinci Xi surgical system. Gordian Surgical (Misgav, Israel) is developing a trocar with a port-site closure device incorporated into the trocar. CareFusion (Vernon Hills, Illinois) introduced a line of reusable micro-laparoscopic instruments that fit through a 2.9 mm inner-diameter trocar, for assuring virtually scarless surgery. Life Care Medical Devices (New Smyrna Beach, Florida) displayed its keyholecup, a dome-shaped device that uses negative pressure to inflate the abdomen with carbon dioxide so that the inserted veress needle will not hit any of the organs. This Class I device has the CE mark. The company has notified the FDA and is awaiting marketing clearance.
Published September 22, 2014