Laparoscopy is endoscopy performed on organs of the abdominal cavity. It is a minimally invasive surgical technique where the surgeon inserts a lighted viewing instrument called a laparoscope through a small incision, about 1cm wide. Laparoscopy facilitates direct visualization of abdominal organs including ovaries, fallopian tubes and uterus as well as the bowel and kidneys. A built-in micro camera projects a magnified real time image on a TV monitor, allowing the surgeon to see surrounding tissues. Both diagnostic and surgical procedures can be done laparoscopically. Laparoscopic surgery may be as simple as occluding fallopian tubes or as complex as organ removal.

The universe includes the following products: Access Devices; Direct Energy Devices (Probes, Generators); Female Sterilization Devices; Gastric Banding; Hand Instruments; Insufflators; Internal Closure devices (Clip Appliers, Endolinear Staplers, Endostaplers, Endosuturing Devices); Laparoscopes (Rod Lens, Video; Reprocessed Laparoscopic Devices; and Suction Irrigation Devices.

MARKET SUMMARY

Leading providers of laparoscopic devices are Aesculap, Covidien (Autosuture, Valleylab), Cardinal Health, Ethicon and Gyrus ACMI/ Olympus.

Female sterilization is the smallest segment of the (1 percent) since this is a very specific procedure. Internal closure devices account for the largest share of the market (34 percent) due to ubiquitous use of these devices in all laparoscopic procedures. Other significantly large markets are direct energy devices and access devices.

Instruments used in all or many laparoscopic procedures include internal closure devices, access devices, direct energy devices and hand instruments. Market share of these segments is influenced by Average Sale Price (ASP) and volume of procedures, which is directly correlated to instrument usability (single use or multiple uses). Apart from closure devices, all others above may be disposable, reusable or reposable. Although closure devices do not necessarily have the highest ASPs, volume of usage and the fact that they can only be used once, makes them the largest segment.

LAPAROSCOPY APPLICATIONS

Laparoscopic surgery is an established procedure in gynecology and gastroenterology. Other specialty areas such as urology and nephrology are increasingly gaining popularity. Applications may be diagnostic or surgical.

Diagnostic Laparoscopy is done to examine various abdominal organs. It is commonly used for the female reproductive system, the most common indications being abdominal or pelvic pain. Other uses include examination of the bowel, appendix, liver and gall bladder.

Disorders most frequently diagnosed laparoscopically are:
oEndometriosis
oPelvic inflammatory disease
oEctopic pregnancy
oOvarian cysts
oAppendicitis

Surgical laparoscopy is used for a wide range of procedures from biopsies to organ removal, female sterilization, weight-loss surgery, cancer treatment, etc. This is a well established procedure for:
oCholecystectomy
oAppendectomy
oHysterectomy
oFemale sterilization
oProstatectomy

Mini-laparoscopy is a relatively recent procedure and uses smaller incisions, ranging between 2-3 mm diameters. It is not useful for many procedures although it inflicts fewer traumas. The procedure is only suitable for patients with certain characteristics such as a thin cavity wall, few adhesions, minimal inflammation, etc., since the instruments are smaller and more fragile with weak suction-irrigation and poorer video quality. However, instruments used for mini-laparoscopic procedures are generally more expensive and fragile. The instruments are also more expensive than other laparoscopic instruments.

TECHNOLOGY TRENDS

Technological advances that have been revolutionizing the laparoscopy field include:

oActive Electrode Monitoring (AEM) from Encision Inc. that allows constant monitoring of power devices to prevent risk of stray burn injury.

oHand-assist devices, e.g. the Hand Port from Smith & Nephew and Gelport Hand Access Device from Applied Medical Inc., give the surgeon a sense of touch and a visual advantage thereby providing more control than traditional laparoscopic surgery.

oRobotic systems are a major technology trend that is driving this industry. This is particularly evident in prostatectomy. Robots have improved surgical efficiency and procedural safety. Costs associated with robotic systems are expected to decrease over time and in some cases such as prostatectomy, they will be the gold standard for treatment in the future.

Other new devices include the following:

oThe Rebound HRD device from Minnesota Medical Development, Inc., designed to assist in the repair and/or reinforcement of hernia or other soft tissue defects with weaknesses. For these situations it is preferable to use the support of a non-absorbable material.

oEndo Grab? from Virtual Ports Ltd. is a device for withdrawing internal organs and securing them firmly to the internal abdominal wall during laparoscopic procedures.

oThe Ternamian ENDOTIP? from Karl Storz is a second generation Visual Port System. It allows optically controllable access to the abdominal cavity and when used with the HOPKINS? II telescope, the surgeon can see and identify the different tissue layers.

oThe Single-Incision Laparoscopic Surgery (SILS(TM)) Kit from Covidien. The SILS(TM) Kit contains laparoscopic devices that can be inserted through the umbilicus. This was developed through research aimed at a new surgical procedure called Natural Orifice Transluminal Endoscopic Surgery (NOTES).

The drive for increasingly minimally invasive technologies is also leading to new technologies that threaten to replace established laparoscopic procedures. For example the Adiana Transcervical Sterilization System developed recently by Hologic, Inc., is a new minimally invasive device that presents an alternative to the highly popular laparoscopic occlusion techniques. The procedure is done either transvaginally or transcervically and therefore does not need any incisions.

COMPETITIVE ACTIVITY

Competitors in the laparoscopy worldwide include the following:

A Henniss, Ackermann Instrumente GmbH,, Advanced Endoscopy Devices Inc., Aesculap USA, Almedic, Allergan, Inc., Anton Hipp GmbH, Applied Medical, Aragon, BK Surgical Ultrasound, Bovie Medical Corporation, BuffaloFilter, Bauer und Haeselbarth-Chirurg GmbH, Biomed Importers Pvt Ltd., Boston Scientific Corp., Blueendo, Bryan Corp., C. R. Bard, Inc., Cambridge, Canada Endoscope Corp., Cardinal Health Medical Products & Services Group, Carl Zeiss Meditec, Civco, COMEG Endoskopie GmbH & Co KG, Contec Medical Ltd., Cooper Surgical Inc., CorTek Endoscopy Inc., Cory Brothers Ltd., Covidien/ Autosuture, Dufner Instrumente GmbH, EFER, Eisenhut Instrumente GmbH , Chirurgie-und Dentalinstrumente, Shenyang Shenda Endoscope Co Ltd., Elmed, Inc., Endoscopy Support Services Inc., Elektromedizin GmbH, Ethicon Endosurgery, Fiegert-Endotech Medizintechnik GmbH, Fujinon Endoscopic Systems, Geister Medizintechnik GmbH, GENICON, GIMMI GmbH, Gyrus ACMI Inc., Hans Hermann GmbH, Hayden Medical, Inc., Henke-Sass Wolf GmbH, Hi-TEC Medical GmbH, Immersion Medical, Innovamed, Intuitive Surgical, KARL STORZ GmbH & Co. KG, Karl-Heinz , Hinze Optoengineering GmbH & Co, Kencap Ltd., KS Instrumente Karl Schad, Labotect Labor-Technik-Goettingen GmbH, Lawton GmbH & Co KG, Medizintechnik, LEXION Medical, LLC., Lumenis Ltd., MAHE International Inc., Marina Medical Instruments, Inc., Medical Innovations, Medical Optics, Medicon eG, MediVision Inc., Microline PENTAX, Novare, Olympus Medical Systems Group, PAJUNK GmbH, Palex Medical SA, Patton Surgical, Pilling Weck Canada LP, Plasma Surgical Ltd., Precision Optics Corporation, Prosurgics, Inc., Proxy Biomedical Ltd., Qiao-Wei Medical Instruments Co Ltd., REMA Medizintechnik GmbH, Richard Wolf GmbH, Schoelly Fiberoptic GmbH, Shanghai Medical Instruments Co Ltd., Simulab Corp., Smith & Nephew Endoscopy, SOLOS Endoscopy, Inc., Starion Instruments, SterilMed, Southmedic Inc., Stryker Corp., Surgical Science, SurgRX, Inc., TAUT Inc., Tekno-Medical Optik Chirurgie GmbH & Co KG, Trendlines Group, Trokamed GmbH, Valleylab, Virtual Ports Ltd., WISAP GmbH, Viking Systems Inc., W. L. Gore & Associates, Inc., XION Medical GmbH