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Dan Cutrone
Canon Communications LLC
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FOR IMMEDIATE RELEASE

39 Innovative Products Win Medical Design Excellence Awards
Winners to receive gold or silver recognition in ceremony at MD&M East trade show

Los Angeles, CA (April 8, 2010) – In its April issue, Medical Device + Diagnostic Industry (MD+DI) magazine has announced the winners of the thirteenth annual Medical Design Excellence Awards (MDEA) competition.

Sponsored by MD+DI and organized by Canon Communications LLC, MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-winning entries excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.

A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics. The 2010 jury selected 39 winners in 10 medical product categories.


2010 MDEA WINNING PRODUCTS (alphabetical by category):

CRITICAL-CARE AND EMERGENCY MEDICINE PRODUCTS

AccuVein AV300 portable, non-contact vein illumination device, manufactured and submitted by AccuVein LLC (Cold Spring Harbor, NY). The AV300 is a portable, noncontact vein illumination device. It helps to find veins not otherwise detectable, thereby helping to reduce multiple needle sticks with the goal of improving patient care and the time to access veins. Supply and design credit to Benchmark Electronics (Rochester, MN).

Hamilton C2 ICU ventilator, manufactured by Hamilton Medical (Bonaduz, Switzerland). Entry submitted by RKS (Thousand Oaks, CA). The Hamilton C2 ICU ventilator can accompany a patient anywhere in the hospital, independently of central gas and power supplies. The ventilator’s easy-to-understand dashboard display reduces pressure on operators and helps minimize errors. Supply and design credit to RKS (Thousand Oaks, CA).

LUCAS 2 chest compression system, manufactured by JOLIFE AB (LUND, Sweden). Entry submitted by Physio-Control (Redmond, WA). The LUCAS 2 chest compression system is a portable, external device that helps sustain circulation in sudden cardiac arrest patients. It assists rescuers in providing effective, uninterrupted chest compressions as recommended in the AHA/ERC guidelines. Supply and design credit to Shift Design & Strategy AB (Gothenburg, Sweden).

Portex UniPerc percutaneous tracheostomy kits, manufactured and submitted by Smiths Medical International Ltd. (Hythe, Kent, United Kingdom). Portex UniPerc tracheostomy kits have been designed to make the percutaneous procedure of placing a tracheostomy tube into patients with large, muscular, short or obese necks quick, safe and effective, at the bedside. Supply and design credit to Avalon Laboratories LLC (Rancho Dominguez, CA), Parker TexLoc (Ft. Worth, TX), Avenue Mould Solutions Ltd. (Sligo, Ireland), and Tumag bvba (Industrieterrein, Belgium).


DENTAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

PaX-Reve3D panoramic, cephalometric, and computerized tomography system, manufactured and submitted by Vatech Co. Ltd. (Gyeonggi-Do, South Korea). The Pax-Reve3D uses three-in-one combination technology (panoramic, cephalometric, and computerized tomography) for diagnosis  in general, orthodontic, implant treatment, and surgery. Supply and design credit to Noble Design (Sungnam-City, Kyonggido, South Korea).

Vibringe sonic irrigation system, manufactured and submitted by Vibringe BV (Amsterdam, NH, Netherlands). The Vibringe is an endodontic sonic irrigation system that enables activation of the irrigation solution, acoustic streaming, in the root canal, in one step. The activation of the disinfectant enriches and completes the irrigation.


FINISHED PACKAGING

Cimzia Packaging, manufactured by UCB Celltech (Slough, United Kingdom). Entry submitted by Smart Design (New York, NY). Cimzia’s packaging is designed to enable self-injection of a pharmaceutical. The package promotes compliance and provides a positive, caring user experience. Supply and design credit to Smart Design (New York, NY), and OXO International (New York, NY).

Orthopaedic Implant Skinpack Package for Femoral Hips, manufactured and submitted by Stryker Orthopaedics (Mahwah, NJ). The orthopedic implant skinpack package for femoral hips is designed to protect both product and package from damage, provide cost savings through package consolidation, and enhance the customer experience with a sleek, foam-free, user-friendly package. Supply and design credit to Alga Plastics (Cranston, RI).


GENERAL HOSPITAL DEVICES AND THERAPEUTIC PRODUCTS

Alice PDx recording device, manufactured and submitted by Philips Respironics (Monroeville, PA). The Alice PDx is a portable diagnostic recording device for obstructive sleep apnea screening, follow-up, and diagnostic assessment of cardio-respiratory sleep disorders. It can be used in a supervised facility or home environment. Supply and design credit to Nonin (Plymouth, MN).

DivibaX mixing transfer device, manufactured and submitted by Promens Medical Packaging A/S (Langeskov, Denmark). DivibaX is designed to provide closed mixing of medical powders into an IV fluid before infusion. With the DivibaX, the vial cannot be removed after mixing; it is attached to the IV bag during infusion.

FreeVac needlestick prevention syringe, manufactured and submitted by Globe Medical Tech Inc. (Houston, TX). The FreeVac’s main purpose is to prevent needlestick injuries. The syringe offers unique vacuum technology by using free air created inside of the plunger to retract the used needle into the barrel after an injection is administered.

HyGreen intelligent hand hygiene system, manufactured by Xhale Innovations Inc., HyGreen division (Gainesville, FL). Entry submitted by ROBRADY design (Sarasota, FL). The HyGreen intelligent hand hygiene system is designed to be a first response against healthcare-associated infection (HAI). The hand wash station, badge, and bed monitor work in concert to monitor and increase adherence to CDC hygiene standards. Supply and design credit to Cobra Design & Engineering Inc. (Saint Petersburg, FL), RF Laboratories Inc. (Oostburg, WI), iTECH (San Diego, CA), ROBRADY design (Sarasota, FL), and Kimball Electronics Group (Jasper, IN).

Littmann electronic stethoscope Model 3200 with Zargis Cardioscan heart sound analysis software, manufactured and submitted by 3M (St. Paul, MN) and Zargis Medical Corp. (Stamford, CT). The 3M Littmann electronic stethoscope Model 3200 offers superior sound quality, onboard recording, and wirelessly transfers sounds to Zargis Cardioscan software that supports the identification and classification of suspected heart murmurs. Supply and design credit to Bang & Olufsen Medicom (Struer, Denmark).

Zio Patch continuous cardiac ECG (electrocardiogram) data recorder, manufactured and submitted by iRhythm Technologies Inc. (San Francisco, CA). The Zio Patch is a single-use, water-resistant continuously recording ECG monitor that can be worn for up to 14 days without removal. It is indicated for use on asymptomatic or symptomatic patients to determine if they are having abnormal heart rhythms.


IMPLANT AND TISSUE-REPLACEMENT PRODUCTS

AngelMed Guardian implantable cardiac monitoring and alerting system, manufactured and submitted by Angel Medical Systems (Shrewsbury, NJ). The AngelMed Guardian implantable cardiac monitoring and alerting system detects rapid ST shifts that may indicate thrombotic coronary occlusions caused by vulnerable plaque ruptures. Emergency alerts urge patients to seek immediate medical attention.

Morphix suture anchor, manufactured and submitted by MedShape Solutions Inc. (Atlanta, GA). Morphix is a shape-memory polymer suture anchor designed for the fixation of soft tissue to bone. Supply and design credit to Enginuity Works (Atlanta, GA), Creature Product Development (Atlanta, GA), and Paragon Medical Inc. (Pierceton, IN).

Orbital tissue expander (OTE), manufactured and submitted by Innovia LLC (Miami, FL). The OTE, composed of an inflatable globe with self-sealing port, uniformly delivers pressure to the bony orbit to stimulate orbital growth for the prevention of facial asymmetry caused by anophthalmia, microphthalmia, and early enucleation in children. Supply and design credit to Bascom Palmer Eye Inst., Anne Bates Leach Hosp., Univ. of Miami (Miami, FL), and The Ophthalmic Biophysics Center., Bascom Palmer Eye Inst., Univ. of Miami (Miami, FL).


IN VITRO DIAGNOSTICS

ABL90 FLEX blood analyzer, manufactured and submitted by Radiometer Medical Aps (Broenshoej, Denmark). The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry on whole blood. It is intended for use at the point of care or in a laboratory.

Contour USB blood glucose monitor, manufactured by Bayer Diabetes Care (Tarrytown, NY). Entry submitted by IDEO (Palo Alto, CA). The Contour USB blood glucose monitor plugs directly into a computer. It autolaunches diabetes management software to provide diabetes patients and healthcare professionals with access to blood sugar data and trends to help optimize diabetes management. Supply and design credit to IDEO (Chicago, IL).

Oragene•DNA self collection kit (OG-500), manufactured by DNA Genotek (Kanata, ON, Canada). Entry submitted by DW Product Development (Ottawa, ON, Canada). The OrageneDNA self-collection kit is a complete system for collection, stabilization, and transportation of DNA from saliva. Once a sample is deposited, the lid closed, a proprietary solution stabilizes it for long-term storage at room temperature. Supply and design credit to DW Product Development (Ottawa, ON, Canada).

PREVI Isola high-throughput specimen and agar plate management system, manufactured by bioMérieux Inc. (St. Louis, MO). Entry submitted by Invetech (Melbourne, VIC, Australia). The PREVI Isola is a high-throughput specimen and agar plate management system. It performs the task of streaking a clinical sample onto an agar plate. Once colonies of bacteria grow, scientists can identify them and diagnose the patient’s disease. Supply and design credit to LBT Innovations Ltd. (Adelaide, SA, Australia), and Invetech (Melbourne, VIC, Australia).


OVER-THE-COUNTER AND SELF-CARE PRODUCTS

GlowCap internet-connected pill bottle cap, manufactured by Vitality Inc. (Cambridge, MA). Entry submitted by BIGfish Communications (Brookline, MA). GlowCaps help people take important medications every day. The internet-connected caps fit on standard prescription pill bottles and raise medication adherence through doctor accountability, social feedback, automatic refills, and daily reminders. Supply and design credit to BIGfish Communications (Brookline, MA).

Oralflo pill swallowing cup, manufactured by Vitality Inc. (Cambridge, MA). Entry submitted by BIGfish Communications (Brookline, MA). GlowCaps help people take important medications every day. The internet-connected caps fit on standard prescription pill bottles and raise medication adherence through doctor accountability, social feedback, automatic refills, and daily reminders. Supply and design credit to BIGfish Communications (Brookline, MA).

Vitala Continence Control Device (CCD), manufactured and submitted by ConvaTec Inc. (Skillman, NJ). Vitala CCD is a pouchless ostomy prosthetic device that restores fecal continence for up to 8 hours for individuals with a colostomy. It seals against the stoma and prevents release of stool while permitting deodorization and release of flatus.


RADIOLOGICAL AND ELECTROMECHANICAL DEVICES

DynaTRIM trans-rectal interventional MRI with DynaCAD digital imaging workstation for prostate, manufactured and submitted by Invivo Corp. (Pewaukee, WI). The DynaTRIM and DynaCAD for prostate pair together to allow minimally invasive, trans-rectal, MRI-guided prostate intervention. Supply and design credit to MeVis Medical Solutions (Bremen, Germany), and Precision Innovations Inc.(Germantown, WI).

SAVI breast brachytherapy applicator, manufactured and submitted by Cianna Medical (Aliso Viejo, CA). The SAVI applicator is a single-entry, multicatheter device for the delivery of radiation therapy for early breast cancers. Its unique design enables physicians to customize radiation and offer the benefits of breast conservation therapy to more women. Supply and design credit to Azure Microdynamics (Lake Forest, CA), Zeus Inc. (Orangeburg, SC), Modified Polymer Components (Sunnyvale, CA), and Fort Wayne Metals (Fort Wayne, IN).

TNT 12000 x-ray test device, manufactured and submitted by Fluke Biomedical (Everett, WA). The TNT 12000 x-ray test device is a versatile instrument for measuring key x-ray imaging parameters. It sets up in seconds and measures kVp, dose, dose rate, time, and half value layer in a single exposure.

Vanguard breast imaging and interventional coil for Siemens MAGNETOM ESSENZA MRI scanner, manufactured and submitted by Sentinelle Medical (Toronto, ON, Canada). The Vanguard transforms a Siemens MAGNETOM ESSENZA MRI scanner into a powerful breast imaging and interventional tool. It includes a patient support structure, adjustable padding, adjustable RF coils, and an angulated biopsy solution.


REHABILITATION AND ASSISTIVE-TECHNOLOGY PRODUCTS

Computerized Prosthesis Alignment System (Compas), manufactured by Orthocare Innovations (Mountlake Terrace, WA). Entry submitted by Orthocare Innovations (Oklahoma City, OK). Compas offers real-time, dynamic gait analysis by measuring forces at the base of the patient-prosthesis interface, analyzing the data and thus providing clinically useful feedback.

Intel Reader digital reading device, manufactured by Intel (Santa Clara, CA). Entry submitted by LUNAR (San Francisco, CA). The Intel Reader is a portable device for people with reading-based learning disabilities or visual problems such as blindness or low vision. The device captures the image of a printed page, converts it to digital text, and reads the content aloud. Supply and design credit to LUNAR (San Francisco, CA).

M320 AlterG anti-gravity treadmill, manufactured and submitted by AlterG Inc. (Fremont, CA). An antigravity treadmill adjustably reduces a patient's apparent weight using an inflatable air bag, allowing therapists to precisely control the amount of impact during rehabilitation for lower extremity injuries and neurological conditions. Supply and design credit to LOEWCO (Palo Alto, CA), and Doug Schwandt Design (Palo Alto, CA).

Tibion Bionic Leg wearable rehabilitation device, manufactured and submitted by Tibion Corp. (Moffett Field, CA). The Tibion Bionic Leg is a wearable robotic device that therapists use to help those disabled by stroke and other diseases to recover their ability to walk without canes and walkers, and to reduce risk of falls–goals rarely achieved with current therapy. Supply and design credit to Claremont Creek Ventures (Oakland, CA), and Fogarty Research and Development (Portola Valley, CA).


SURGICAL EQUIPMENT, INSTRUMENTS, AND SUPPLIES

Ajust adjustable single-incision sling, manufactured and submitted by CR Bard, Bard Medical Division (Covington, GA). The Ajust sling is designed to treat stress urinary incontinence in women. The sling is secured in the patient’s tissue with two tissue anchors. An introducer inserts anchors. The mesh locks by an element deployed using a flexible stylet.

Duet TRS Reload Tissue Reinforcement System, manufactured and submitted by Covidien (North Haven, CT). The Duet TRS reload is an endoscopic stapler with an integrated, synthetic absorbable tissue reinforcement designed to support the staple line.

FinESS Sinus Treatment, manufactured by Entellus Medical (Maple Grove, MN). Entry submitted by Kablooe Design (Blaine, MN). FinESS Sinus Treatment is a less-invasive option for physicians and their patients compared with FESS. It’s an endoscopic procedure that can be performed under local anesthesia and opens and reshapes the sinuses behind the cheekbones and between the eyes. Supply and design credit to Kablooe Design (Blaine, MN).

Hydrodebrider endoscopic suction irrigator system, manufactured and submitted by Medtronic ENT (Jacksonville, FL). The Hydrodebrider system is a powered endoscopic suction irrigator that is intended to remove bacteria from the paranasal sinuses of patients with acute or chronic sinusitis. Supply and design credit to Metaphase Design Group Inc. (St. Louis, MO).

Quill SRS knotless surgical wound closure device, manufactured and submitted by Angiotech Pharmaceuticals Inc. (Reading, PA). The Quill SRS is a knotless surgical wound-closure device that has tiny barbs on its surface. It is approved for the approximation of soft tissues. The barbs penetrate into the surrounding tissue and lock the device in place. Supply and design credit to Gregory L. Ruff MD (Chapel Hill, NC).

RIO robotic arm interactive orthopedic system, manufactured and submitted by MAKO Surgical Corp. (Ft. Lauderdale, FL). RIO is a robotic arm interactive orthopedic system that enables consistently reproducible precision with MAKOplasty partial knee resurfacing.  It incorporates a surgeon-guided robotic arm and patient specific visualization. Supply and design credit to FARM Design Inc. (Hollis, NH).

SERENGETI Minimally Invasive Retractor System, manufactured and submitted by K2M Inc. (Leesburg, VA). The SERENGETI disposable retractor is a screw-based, flexible, polymer retractor that can be opened at its distal end to offer the surgeon direct visualization to the pedicle screw for simple rod insertion. Supply and design credit to Orchid MacDee (Chelsea, MI).


Winning products will receive gold or silver recognition at a ceremony held June 9, 2010 during the Medical Design & Manufacturing (MD&M) East 2010 Conference and Exposition (www.MDMEast.com) at the Jacob K. Javits Convention Center in New York City.

The MDEA program is presented by Canon Communications LLC with corporate sponsorship provided by major industry suppliers, The MedTech Group Inc., Nordson EFD LLC, and Vante.

For more information about the Medical Design Excellence Awards—including additional details about the manufacturers and suppliers that created the 2010 MDEA-winning products—visit the MDEA Web site at www.MDEAwards.com or e-mail: mdea@ubm.com.

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