BB&T Contributing Editor

JERUSALEM – The World Congress for the Advancement of Surgery in Israel was planned by Scott Shikora, MD, Chief, General Surgery and Bariatric Surgery, and Director of Minimally Invasive Surgery at Tufts University School of Medicine (Boston), “to nurture collaboration and cooperation by creating an international surgical society and to explore the challenges of surgical training.“ It attracted top surgeons from 16 countries to review the state-of–the art in surgical oncology, bariatric and minimally invasive surgery and trauma/critical care. The World Congress was organized by Target Conferences (Tel Aviv).

Shikora reviewed neuromodulation methods as an alternative to lap bands, surgical bypass and sleeve procedures which some obese patients reject due to the presence of foreign bodies or because of metabolic issues. Neuromodulation was differentiated from neuroblocking which uses a higher frequency and shuts down motor and stimulus functions. He reviewed devices for gastrointestinal electrical stimulation, such as the Transcend gastric pacemaker from Transneuronix, a subsidiary of Medtronic (Minneapolis), and focused on the issues of undefined signal intensity and frequency of stimulation, unknown mehanism, and whether to stimulate the vagus or sympathetic nervous system. In a clinical trial on 800 patients only a subset of patients responded to the treatment. Other implantable devices were reviewed including the Tantalus gastric pacemaker from Metacure (Bermuda) which uses a sensor for meal-activated gastric stimulation, and VBLOC vagal blocking therapy from EnteroMedics (St. Paul, Minnesota). Shikora concluded that neurostimulation for weight loss is still “not ready for prime time.“

Henri Bismuth, MD from Hopital Paul Brousse (Villejuif, France) reviewed the evolution of liver surgery. It has become its own specialty in Europe, where liver transplant surgeons are the only ones that perform this procedure, a development that Dr. Bismuth strongly favors. In the U.S., organ transplant surgeons perform liver, kidney and pancreas transplants.

Pursuing Medical Tourism

Assuta Medical Centers (Tel Aviv) opened a 320-bed private hospital in May 2009 and has begun promoting medical tourism for its network hospitals throughout Israel. It currently attracts mostly patients from Russia, but plans to seek patients from other geographic regions. Assuta is the leading private hospital group in Israel and is the biggest surgical center in the Middle East.

Device companies in all surgical specialties

Israel is home to hundreds of medical device startup, development stage and emerging companies. The country fosters entrepreneurship by housing many of these companies within incubators. Their products encompass the full range of medical specialties. Some of these innovative companies made presentations at the conference and are highlighted below.

Endoscopes and ancillary devices

• Smart Medical Systems (Ra'anana) is developing disposable balloon devices that are added on to commercially available endoscopic equipment for use in gastrointestinal endoscopy. Its first product, NaviAid BGE, has the CE mark and received market clearance from the FDA. It is marketed in Europe by Pentax Medical (Hamburg, Germany) and a distribution network is being established in other regions. Balloon Guided Endoscopy (BGE) enables small bowel diagnosis utilizing standard GI endoscopes. A sleeve with a balloon is slipped onto the endoscope tip and the trailing catheter is secured along the length of the endoscope using silicone bands. It is advanced deep into the small intestine while utilizing existing endoscope optics. An air supply unit is used to inflate the balloon and anchor the endoscope. The NaviAid BGE obviates the need to purchase a dedicated small bowel endoscopy system. It was launched at the annual meeting in October 2008 of the United European Gastroenterology Federation (UEGF; Vienna).

• Medigus (Omer) designs and manufactures endoscopy systems, including rigid, semi-flexible and flexible video endoscopes. It has developed a proprietary single-use endoscopic device (the SRS) for the treatment of gastroesophageal reflux disease (GERD), known as the fundoplication procedure. The company reported in August 2009 its development of the world's smallest (1.2 mm diameter) video camera for endoscopy. It is intended for single use medical applications, eliminating the need for costly sterilization, and features high performance at low cost. The camera is expected to be incorporated into disposable endoscopes and used in diagnostic and surgical applications in extremely confined areas of the human body. The camera uses tiny electronics and objective lenses and a CMOS imager measuring 700 x 700 microns that is supplied by Tower Semiconductor (Migdal Ha'emek). Mass production of the camera is expected by mid-2010. Potential applications include gastroenterology, urology, Natural Orifice Transluminal Endoscopic Surgery (NOTES), bronchoscopy, ENT, cardiovascular, etc.

• EasyGlide (Kfar Truman) provided a video presentation of its ClearPath irrigation and evacuation system for optimal viewing of the colon. The company has developed a disposable suction irrigation unit that is compatible with all colonoscopes and enhances irrigation and removal of debris. The ClearPath device employs a combination suction and irrigation head that encircles the distal tip of the colonoscope and increases the diameter of the colonoscope by about 8 mm. The proximal end of the scope is attached to a control console that contains a water supply and waste tank. Suction and irrigation are controlled using a foot pedal. The ClearPath system can be used on the upper and lower GI tracts and in colorectal surgeries as an intra-operative procedure when colon cleansing is needed. The ClearPath system has the CE mark and clearance from the FDA. It is the subject of five patent submissions. Sales are expected to commence early in 2010. Future products in the company's pipeline include disposable instruments, including clips and biopsy forceps.

• G.I. View (Ramat Gan) is developing endoscopes for the early diagnosis of gastrointestinal precancerous tumors. Aer-O-Scope is a disposable, air-driven, self-propelling, self-navigating endoscope incorporating a miniature CMOS camera with an omni-directional viewing system. Its visual system provides high resolution and 360^o images of the colon's inner surface that are displayed on a screen for real time viewing of the colon's entire mucosal surface, eliminating the need for continuous tip manipulation in colonoscopy, and potentially decreasing the chance of missing polyps hidden behind mucosal folds. The images are digitally recorded for future viewing. An electro-optical capsule is embedded in the front of a lightweight balloon, while low pressure colon insufflation with CO₂ propels the balloon, causing it to glide along the colon walls without forceful maneuvering. Computer controlled pressure management, coupled with sensors in the workstation, adjust balloon size and shape to the changing bowel anatomy, thus allowing the pressure-propelled balloon to find its path. The Aer-O-Scope allows for a safe, less threatening and less painful alternative to conventional colonoscopy. It is less skill dependent, potentially allowing increased patient throughput in a cost effective way. The Aer-O-Scope is in the final stages of development. It has been successfully tested on healthy human volunteers and has received the CE mark. G.I. View plans its future entry into the U.S. market.

The core technology used in the Aer-O-Space product was initially developed for use in armored vehicles to provide a 360^o panoramic view for sweeping the outside surroundings of the vehicle for potential threats. This is indicative of Israel's prowess in converting military technology for civilian or medical applications. Perhaps the best known example of such a technology transfer is the Pillcam from Given Imaging (Yokneam), an ingestible capsule containing a miniature camera for video endoscopy which transmits thousands of images as its passes through the small intestines.

Devices for robotic surgery

• Mazor Surgical Technologies (Caesarea) develops and markets medical devices for orthopedic procedures. Its core technologies include semi-active surgical robotics and medical 3-D imaging. Mazor's SpineAssist robotic guidance system is used in a wide range of spinal procedures and is cleared for sale in the U.S., Europe and Korea. It has been clinically shown to yield accurate results in more than 1,000 cases with zero cases of nerve damage reported to date. C-InSight is a software based intra-operative imaging system that transforms images from existing 2-D C-arms into 3-D reconstructions. The company has entered into an exclusive worldwide licensing agreement with the Cleveland Clinic for a guided oblique lumbar interbody fusion (GO-LIF) solution for robot-assisted percutaneous spine surgery that uses the SpineAssist guidance system. Mazor's SpineTheater offers hospitals a one stop shop solution, encompassing robotic guidance, intra-operative imaging and minimal invasive spine implants, thereby leveraging Mazor's core technologies.

Mazor's products are marketed in Germany and are being expanded into other European countries, Russia and Israel. During 2010, the company plans to initiate marketing of its products in the U.S. It maintains regional offices in Munster, Germany and Norcross, Georgia.

• Medical Surgical Technologies (MST; Caesarea) is in late stage development of a miniature robotic laparoscopic positioning system for use in image-guided minimally invasive surgery. The MST system consists of (1) a disposable sticker button that can be placed on any laparoscopic tool, (2) a slim, agile and very low profile robotic arm that can be placed anywhere around the operating room table, and (3) image processing and tracking software embedded in the systems' robotic arm. The robotic laparoscope positioning device tracks and follows surgical tools at the press of a button. It automatically maneuvers the laparoscope to the desired view without surgeon involvement, allowing for a seamless and fluid surgical workflow and thereby excluding the time-consuming coordination and communication between the surgeon and assistant. The company's pipeline of robotic-based products for minimally invasive procedures includes are for use in SILS (single incision laparoscopic surgery) and FESS (functional endoscopic sinus surgery). The company has nine pending patent applications of its core technology.

Surgical wound closure devices

• NiTi Surgical Solutions (Netanya) has developed a line of Nitinol-based tissue closure devices used for anastomosis in GI surgery. Its ColonRing endoluminal device is naturally expelled from the body after circular homogeneous compression anastomosis is achieved, thereby avoiding permanent implants such as staples remaining in the body. The ColonRing has the CE mark and market clearance from the FDA. The company showcased at the recent annual meeting of the American College of Surgeons its new investigation BowelRing for use in side-to-side anastomosis in the small bowel and right colon procedures

• Seraffix (Misgav) is developing the LTB tissue closure device that is based on the laser activation of protein. It comprises two elements, a robotic device with a CO₂ laser system, and a wound dressing kit with a protein spraying system. It is claimed to be the first automatic closure manipulator for multilayer-depth closure and to enable laser soldering of wounds with less scarring than occurs with traditional closure methods or with adhesives. The platform allows for easy modulation of the CO₂ laser's intensity and includes a laser scanner that scans the entire incision. A bonding enhancement material is sprayed over the incision and a smart wound dressing strip enables a robotic system to manipulate the wound's edges. The LTB is controlled by computerized software. An alpha prototype has been designed for use in clinical trials to close straight line cuts up to 6 cm length. A beta prototype is planned that will function as a multi-tasking device for closing every type of surgical incision and will be the model for future regulatory submissions.

Products for laparoscopic surgery and hernia

• Virtual Ports (Misgav) has developed tools that overcome the need for hand-held retractors during laparoscopic surgery, allowing for the introduction of instruments into the abdominal cavity without the need for additional access ports. EndoGrab, an internally anchored and hands-free retracting device, is introduced at the start of surgery by means of a proprietary introducer tool. It is attached to the organ requiring retraction (such as the colon) and then to the internal abdominal wall, thereby exposing the operative field. The introducer is then removed and the port is free for use by other instruments. EndoGrab is marketed in the U.S. and in several European countries. The EndoClear device is an internally anchored device in the abdominal cavity. It has cleaning surfaces on which the laparoscope lens can be wiped during surgery without the need to remove the laparoscope. It will be launched in 2010.

• EZ Surgical (Yokneam) sells its DASH malleable retractor products in the U.S. through an exclusive distribution agreement recently executed with Medline Industries (Mundelein, Illinois). DASH provides lap pad absorbency and is available in four sizes. HandDASH is designed to enhance retraction and visualization during hand-assisted laparoscopy. The company plans to have future sales in the U.S. of its A-Lap 3-D retractor/displacement device that comes with a dedicated soft flexible port, or may be deployed through an existing skin incision. Features include an atraumatic mesh controlled by an intuitive handle design allowing the user to manipulate and lock-in the degree to which the device is opened. This allows for multiple applications, any place where atraumatic tissue or organ displacement is required. When opened, there is no volume loss as compared to traditional laparoscopic retractors.

• PolyTouch Medical (Misgav) is developing PatchAssist, a novel mesh deployment and placement device for laparoscopic ventral hernia repair. The device, together with the folded mesh, is inserted through a standard laparoscopic port. Once inside the abdominal cavity, the device unfolds the mesh and serves as a flexible support frame to hold and place the mesh. The surgeon can verify the ideal location before any attachment is made. The mesh is affixed using standard methods – hernia tacks or sutures – while it is held firmly in place by the PatchAssist device. Once it is attached, the device releases the mesh and is extracted through the laparoscopic port. The advantages of this approach are quicker mesh deployment with reduced operating time and a lower risk of hernia recurrence due to accurate mesh positioning. Four patent applications have been filed. The company plans to submit a 510(k) for FDA clearance.

• Easy-Lap (Kfar Truman) has developed the iMESH kit that contains three products used for laparoscopic hernia repair, the iMESH Placer deployment device, the spiral and absorbable iMESH Tacker for mesh fixation, and the iMESH Stitcher for single-handed suturing. The products will be launched in the U.S. in April 2010 at the annual SAGES conference and will be distributed by Global Medical (Elkridge, Maryland).

• Surgical Structure (Kiryat Shemona) is developing devices for hernia repair that allows for insertion of the mesh and through a single 1.2 cm incision and the quick deployment and positioning of the mesh in a posterior approach. The system can be used for repair of ventral and inguinal hernias and for use with all kinds of commercial mesh products.

Products for ophthalmic and optic surgery

• IOPtima (Ramat Gan) is developing OT-134, a CO₂ laser-based trabeculectomy procedure known as IOPtiMate, for treating glaucoma patients. It enables eye surgeons to operate and reduce the eye pressure without penetrating the eye membrane. Once sufficient liquid is drained and a desirable intraocular pressure (IOP) level is attained, the laser automatically stops working, eliminating the risk of perforating the eyeball. In a multi-site clinical trial, 30 patients have completed one-year follow up at glaucoma centers in Mexico City, India and Russia. The study results suggest that IOPtima's laser filtration system may offer significant efficacy and safety advantages in alleviating IOP, as well as reduce potential risks, side effects and complications over current surgical procedures. Additional multi-site clinical trials have been launched in Europe. IOPtima has received the CE mark for its system and plans to pursue regulatory approval in the U.S. The company has U.S. and European patents on its product. Nearly 67 million people worldwide suffer from glaucoma, a chronic disease that requires lifelong therapy.

• ENT-Surgical (Yokneam) is developing the Myringo family of surgical devices for performing safer, faster and less traumatic myringotomy and ventilation tube insertion procedures. Myringotomy allows drainage of fluid from the middle ear and is the most common surgical procedure in pediatrics, with over 1.1 million procedures performed annually in the U.S. alone. Myringo devices enable physicians to perform the incision, suction and ventilation tube insertion using a single device in a fast (37 seconds), simple in-office procedure that can be performed under local or topical anesthesia. The Myringo device is not yet approved for commercial distribution. The company plans to file a 510(k) with the FDA and expects to receive to market clearance early in 2010.

• Nicast (Lod) is developing medical devices made from electrospun nanofabric. The company plans a European launch early in 2010 of its NovaMesh intra-abdominal hernia mesh. In preclinical animal studies, NovaMesh demonstrated resistance to adhesions on the organ facing surface, tissue regrowth on the fascial surface, and minimal mesh shrinkage. The company has also developed the AVflo artificial vascular graft for use by patients with end-stage renal failure that self-seals within less than five minutes following withdrawal of the dialysis needle.