News and Trends—May 2010

| May 19, 2010

Covidien Innovation: Delivered Mobile Surgical Tour Initiative Brings Single-Incision Laparoscopic Device and Groundbreaking Procedures to Surgeons around the Country
NORTH HAVEN, Connecticut—BUSINESS WIRE—Covidien, a global provider of healthcare products, announced the launch of the “Innovation: Delivered” tour, a mobile program that will introduce surgeons, residents, nurses, and hospital administrators around the country to the SILS™ Port Multiple Instrument Access Device.
The SILS Port is an advanced, single-incision laparoscopic device that reduces the four 1/2-inch or smaller incisions normally associated with traditional laparoscopic surgery to just one incision in the belly button. The SILS Port procedures are used in gynecologic, bariatric, and urologic surgeries, among other specialties. The Innovation: Delivered tour features a state-of-the-art operating room-style facility housed in an 85-foot, nearly 80,000-pound tractor-trailer that will travel around the country to bring these advanced laparoscopic surgery tools directly to surgeons and hospitals. When parked, the truck expands to a 1,200-square-foot facility with a conference room, clinical training area with advanced audio-visual tools and five operating room stations that will accommodate 10 surgeons simultaneously.
The hands-on workshops will be staffed by trained experts demonstrating the SILS Port technology and procedures. The mobile facility is fully equipped with the latest technology and resources, enabling surgeons to explore the new surgical advancements on tissue and torso trainers and to provide better patient outcomes, including less pain and improved cosmesis following surgery.
The Innovation: Delivered tour is scheduled to visit 19 cities over the next few months, including Atlanta and Macon, Georgia; Fayetteville, Greensboro, and Raleigh, North Carolina; Memphis, Tennessee; and Miami and Tampa, Florida. Covidien launched the SILS Port at the 2009 annual convention of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

New Adjustable Intragastric Balloon Appears Well-Tolerated, Demonstrates Significant Weight Loss—Spatz-FGIA to Present Clinical Data at DDW 2010
NEW ORLEANS, Louisiana—PRNewswire—A new adjustable intragastric balloon appears to help patients with obesity lose significant amounts of weight and could be more tolerable than traditional intragastric balloons, which must be removed after six months. Six-month data from a pilot study of Spatz-FGIA Inc.’s Adjustable Balloon System were presented in a poster at Digestive Disease Week (DDW) 2010 in New Orleans, Louisiana.
The study included 18 patients (15 female, 3 male), average 38-years old, with a mean body mass index (BMI) rating of 39.4kg/m2 and a mean weight of 114.9kg (252.8lbs), who were implanted with the Spatz Adjustable Balloon System. After six months from the time of balloon implantation, four of the five balloons were in place and these four patients were able to lose more than half of their excess weight (50.8% EWL with a mean weight loss of 23.5kg (51.8 lbs).
A specially-designed valve on the Spatz Balloon System allows the balloon volume to be adjusted in the patient’s stomach via a routine endoscopy procedure. These volume adjustments enabled renewed balloon effect after the first two to three months in this study.
Investigators plan to extend the study for another six months to determine if an adjustable intragastric balloon can be a solution for chronic endoscopic weight loss therapy. For more information, visit www.ddw.org.

KARL STORZ OFFERS KEY CAPITAL EQUIPMENT PLANNING INFORMATION THROUGH ATTAINIA’S ONLINE PORTAL
EL SEGUNDO, California—Karl Storz Endoscopy-America, Inc., a diagnostic and operative minimally invasive endoscopic technology company, has signed a three-year agreement with Attainia, an online marketplace for capital equipment, to make information available about key solutions for operating room integration and video imaging products. Attainia’s web-based software applications have been developed to enable hospitals, health systems, and equipment planners/architects to manage healthcare projects and budgets more effectively.
Equipment planners and architects are overwhelmed with the world’s constantly growing and fast changing equipment market, which they must access to properly plan new building and renovation projects. The availability of Attainia’s Web-based service has the potential to conserve time, money, and resources compared with doing it themselves. For more information, call (800) 421-0837 or visit the company’s website at www.karlstorz.com.

MICROLINE SURGICAL AND CAMBRIDGE ENDO ANNOUNCE PRODUCT DEVELOPMENT AND DISTRIBUTION PARTNERSHIP

Beverly, Massachusetts—Microline Surgical, a manufacturer of reposable instruments for minimally invasive surgery, and Cambridge Endo, a company in the single-incision surgery market, announced a product development and distribution partnership through which Microline will serve as a distribution channel for Cambridge Endo’s products and the two companies will collaborate on new solutions to advance the state of minimally invasive surgery.
One of Cambridge Endo’s new technologies is a redesigned handle for its Autonomy™ instrument product line. Designed to enable surgeons to overcome the unique challenges presented by single-incision surgery, the improved handle size and shape minimizes instrument crowding or clashing that is often encountered during minimally invasive procedures.
For more information about Microline Surgical, visit www.microlinesurgical.com.
For more information about Cambridge Endo, please visit www.cambridgeendo.com

Ardea Biosciences Announces Positive Top-Line Results from a Phase 2b Study of RDEA594 Given as Monotherapy in the Treatment of Hyperuricemia in Gout Patients
SAN DIEGO, California—PRNewswire-FirstCall— Orexigen® Therapeutics, Inc. has submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
The safety profile of Contrave was found to be consistent with the safety of the two approved active ingredients. The most common adverse reactions (>5% and at least twice the incidence of placebo patients) were nausea, constipation, vomiting, dizziness, and dry mouth. Serious events were reported infrequently and included events of cholecystitis (NB 0.2%, PBO <0.1%), seizure (NB <0.1%, PBO 0%), and major cardiovascular events (NB <0.1%, PBO <0.1%).
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. In addition to Contrave, the company’s second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. For more information on Orexigen, please visit www.orexigen.com.

Prospective, Randomized Trial Shows Significantly Better Patient Outcomes in Selected Surgical Procedures within 30 Days When ChloraPrep is Used Preoperatively, Compared to Povidone-iodine
SAN DIEGO, California—Data published in The New England Journal of Medicine demonstrated that use of CareFusion’s patient preoperative skin preparation ChloraPrep® (2% chlorhexidine gluconate and 70% isopropyl alcohol) reduced total surgical site infections (SSIs) by 41 percent, from 16.1 percent to 9.5 percent, compared to use of povidone-iodine solution, the most commonly used preoperative skin preparation.
This prospective, randomized, multicenter, well-controlled outcomes clinical trial enrolled 897 patients at six hospitals in the United States; 849 patients were included in the analysis.
For more information, visit www.carefusion.com.

Detecto Model 655p Versatile MultiTasking Bariatric Scale
Detecto’s made-in-the-USA model 6550 portable wheelchair scale offers a sturdy, but lightweight design that can be used with wheelchairs, walkers, straight-legged chairs, or as a stand-on scale. The scale’s integral sloped ramps offer versatility by allowing loading from either side. The 6550’s unique vertical fold-up feature saves storage space and the heavy-duty wheels contribute to its ease of mobility. Wheelchair tare weights may be either preset or keyed in directly to provide the patient’s actual weight when being weighed in a wheelchair.
The 6550 scale comes with EMR-ready USB, serial, and optional ethernet connectivity. With the time/date feature, this American-made scale can send patient data directly to a printer or PC for efficient record keeping. It features a high 800lb/360kg capacity with accurate 0.2lb/0.1kg increments, which may be used for bariatric weighing. Battery or optional AC power, durable steel construction, and heavy-duty scale base for patient assurance while weighing are just a few of the numerous features. With the push of a button, readings appear in pounds or kilograms, plus it features a BMI bar graph. BMI calculations have been shown to be an accurate estimate of health risk when used as part of a comprehensive health assessment.
For more information, please visit www.detecto.com/6550.htm.

New DETECTO EMR-Ready Bariatric Scale with High Return on Investment
Detecto’s made-in-the-USA model 6857DHR portable bariatric scale features Detecto’s exclusive digital height rod and 758C weight display, so the patient may simply stand on the scale, raise the digital height rod into position, and all patient data (height, weight, and BMI readout/bar graph) are displayed simultaneously onscreen. Saving several labor hours per week in a busy office easily justifies investment in this scale in less than three months. As an added bonus, the model 6857DHR is EMR-ready with its inclusive serial, USB, and optional ethernet connections for the office network. With the time/date feature, this American-made scale can send patient data directly to a printer or PC for efficient record keeping. Detecto can provide easy answers to the busy medical office for EMR connectivity now and in the future.
DETECTO’s 6857DHR is engineered specifically for weighing patients with obesity and unsteady patients and features a 24-inch (610mm) square, low-profile platform with nonskid surface and sturdy handrails with padded grips. The 6857DHR features a high 800lb/360kg capacity with accurate 0.2lb/0.1kg increments, which may be used for bariatric weighing. Battery or optional AC power, durable steel construction, stainless steel tubular handrails, and heavy-duty scale base for patient assurance while weighing are just a few of the numerous features. With the push of a button, readings appear in pounds or kilograms, plus it features a BMI bar graph. BMI calculations have been shown to be an accurate estimate of health risk when used as part of a comprehensive health assessment. This scale is also available without the digital height rod: model 6857.
For more information, please visit www.detecto.com
/6857DHR.htm.

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