A first-of-its-kind system designed to eliminate wrong-site surgery has been approved by the FDA. The SurgiChip, a radio frequency identification (RFID) solution that uses RFID printer/encoders and labels from Zebra Technologies (Vernon Hills, Illinois), was cleared via a 510(k) for marketing in the U.S.

The system embeds and prints information on an RFID "smart" label that travels with the patient into surgery to help prevent errors. The company said the system should be viewed as another vital safeguard to prevent wrong-site, wrong-patient and wrong-procedure medical errors. The SurgiChip can be programmed and used in many types of surgical procedures.

The chip was invented by Bruce Waxman, MD, an orthopedic surgeon and founder of SurgiChip (Palm Beach, Florida) and developed by AMT Systems (Cheshire, Connecticut) a healthcare applications integrator and reseller for Zebra.

According to Peter Stanchfield, RFID marketing manager for AMT Systems, Waxman approached Zebra Technologies about using its printer and coder in tandem with his RFID technology. "Zebra referred [Waxman] to us," he said. "We are one of Zebra's RFID solutions specialists as well as one of their healthcare market-focused value-added resellers."

He said AMT put together the hardware necessary to perform all the steps of the procedure as well as writing all of the software needed to read and encode the chips. "We have a co-development and co-marketing agreement with Dr. Waxman and SurgiChip," he said. The FDA said in a press release that the SurgiChip is the first such surgical marker to utilize RFID technology to mark an anatomical site for surgery.

Elsewhere in the product pipeline:

Angiotech Pharmaceuticals (Vancouver, British Columbia) unveiled what it said was "encouraging" preliminary eight-week follow-up data on 20 patients from a single center in its pivotal European study using Adhibit to reduce the incidence and severity of adhesions following laparoscopic surgery in a gynecological population. Data from this pivotal trial may be used to support the European submission for consideration of CE mark approval and commercialization in Europe. Adhesions often occur when tissues heal following suturing, incision, infection, foreign bodies and trauma (tissue damage) that are caused by virtually any kind of surgery. Studies have shown a high rate of adhesion formation following gynecological surgery and hysterectomies. These adhesions often cause severe pain, discomfort, limited range of motion and organ dysfunction. The study involves 75 patients in total randomized 2:1 and was initiated at four centers in Germany, Europe and the Netherlands Antilles. It is designed to evaluate safety and efficacy of Adhibit for the prevention of post-surgical adhesions (in patients undergoing laparoscopic surgical removal of fibroids from the uterus. Both laparoscopic and traditional open surgical approaches were permitted. The test group had Adhibit sprayed onto the surgical sites, while the control group was left untreated.

BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) reported the release of version 6.0 of its BD.id Patient Identification System for specimen management. The company said the BD.id System improves hospital operational efficiency and enhances patient safety by reducing the potential for medical errors during the specimen management process. The latest release of the BD.id System features several new product improvements, including embedded analytics with enhanced reporting capabilities. In addition to multiple hardware upgrades, the BD.id software is now based on the Windows Mobile operating system. Its enhanced HL7 bi-directional interface enables better exchange of information between the laboratory information system and the BD.id System software. The BD.id System not only matches patients to tests, it also matches tests to the required specimen containers to help ensure tests can be completed properly.

BlueSky Medical Group (La Costa, California) said the FDA cleared the Versatile 1 Wound Vacuum System for marketing and the Centers for Medicare & Medicaid Services confirmed Medicare coding decisions made to Versatile 1 products. The Wound Vacuum applies localized negative pressure to a wound bed to promote healing. In addition to Medicare reimbursement, Blue Sky said Anthem BlueCross has rewritten its reimbursement policy to include the Versatile 1 pump as a covered product under its Negative Pressure Wound Therapy in the Home Environment policy.

Cardima (Fremont, California) reported a 70% rate of success in treating 22 atrial fibrillation patients with its Surgical Ablation System (SAS), based on data compiled by doctors at Lenox Hill Hospital (New York). Six-month follow-up data found that 70% of the patients treated with SAS remained in normal sinus rhythm. SAS ablates cardiac tissue during heart surgery using radio frequency energy. Cardima said it believes that the system can reduce the time required to form lesions and can sense tissue temperature interactively to ensure lesions are uniform, thin and linear.

Conceptus (San Carlos, California) said data pre- sented at the American Association of Gynecologic Laparoscopists meeting showed a significant cost savings when performing Essure vs. incisional tubal ligation. Fifteen abstracts featuring the non-incisional alternative to tubal ligation for women seeking permanent birth control were presented at the meeting. Among these, Mayo Clinic (Rochester, Minnesota) researchers found cost savings in the operating room when comparing the Essure procedure to tubal ligation. The savings are largely attributable to lower hospitalization costs for the Essure procedure, which does not require cutting or penetration of the abdomen and can be performed without general anesthesia.

CryoCath Technologies (Montreal) has received regulatory approval from the People's Republic of China to market both the Freezor CryoAblation System and the Arctic Circler CurviLinear. Freezor and Arctic Circler will complement CryoCath's existing electrophysiology and interventional cardiology franchises. Pacific Medical, a cardiology company focused on the Chinese market, will distribute the products.

CTI Molecular Imaging (Knoxville, Tennessee) reported that its subsidiary, CTI PETNET (also Knoxville), will release and distribute PET.CONNECT, an application featuring a range of IT products, educational programs and service offerings, designed to provide all the capabilities necessary to run a positron emission tomography (PET) imaging practice. The Image Analysis software in PET.CONNECT, created by CTI Mirada Solutions (Oxford, UK), includes a suite of diagnostic applications spanning oncology, neurology and cardiology.

Five-year data on Cytyc's (Boxborough, Massachusetts) NovaSure System for endometrial ablation presented at the American Association of Gynecological Laparascopists meeting showed that 97% of patients achieved reduction in bleeding to normal levels or less, with more than two-thirds reporting amenorrhea, the complete cessation of bleeding. The data were from a study on the procedure completed by Hungarian doctor Tamas Fulop, MD, who was the first to perform the procedure, and presented by Richard Gimpelson, associate clinical professor in the department of obstetrics, gynecology & women's health at St. Louis University School of Medicine. Hysterectomy due to excessive menstrual bleeding was avoided in 100% of cases. Cytyc also reported that 11 studies evaluating the performance of its ThinPrep Imaging System were presented in November at the American Society of Cytopathology meeting in Chicago. The studies reported on a range of implementation and performance criteria including validation protocols, disease detection and impact on workload.

Eastman Kodak (Rochester, New York) said its Health Imaging Group has received FDA approval for its mammography computer-aided detection (CAD) system. Kodak will immediately begin shipping its Kodak Mammography CAD System to healthcare facilities in the U.S. Kodak CAD software was engineered for ease of use and integrates smoothly into existing radiology workflow.

Genetronics Biomedical (San Diego) reported that the company has begun treating skin cancers in patients with primary and recurrent solid tumors requiring potentially disfiguring surgical treatment in a European clinical study using its MedPulser Electroporation Therapy System. This premarketing Phase IV study is a multi-center, open-label study that will measure clinical efficacy based on local tumor control through a six-month post-treatment period and assess local and systemic safety and tolerance. It also will evaluate pharmacoeconomic benefits, including reductions in surgical and hospital costs.

Hitachi Ubiquitous Business Solutions (UBS; San Jose, California) reported the launch of VisionPlate MD, an addition to Hitachi's flagship line of lightweight touch-screen tablets. The HIPAA-ready VisionPlate MD facilitates implementation of electronic medical record (EMR) point-of-care and point-of-service solutions within hospitals, clinics and other ambulatory environments. UBS said the hermetically sealed VisionPlate MD is the only such touch-screen tablet on the market that is certified as a medical device.

IRIS International (Chatsworth, California) reported the introduction of the iQ200 Sprint Automated Urinalysis System, a high-throughput analyzer designed for high-volume clinical reference laboratories and hospitals. Commercial shipments of the new system will begin in 1Q05. The iQ 200 Sprint can process more than 100 specimens per hour.

LeMaitre Vascular (Burlington, Massachusetts) premiered its AnastoClip Vessel Closure System at the VEITHSymposium in New York. Acquired from U.S. Surgical (Norwalk, Connecticut), a unit of Tyco Healthcare, the device is cleared for sale in the U.S., European Union and Japan. The AnastoClip VCS Vessel Closure System provides rapid and precise vascular anastomosis, replacing traditional sutures. Titanium AnastoClips, placed in an interrupted fashion, facilitate a compliant anastomosis without penetrating the vessel lumen, the company said. That allows the anastomosis to contract and expand to accommodate pulsatile flow. The system is used in a variety of vascular procedures, most commonly in vascular access for hemodialysis patients.

Medtronic (Minneapolis) reported the launch of IMPROVE HF, a landmark registry to help physicians evaluate the quality of care provided to heart failure patients and improve treatment rates for proven drug and device therapies for heart failure. IMPROVE HF will be the largest heart failure registry ever undertaken in the outpatient setting, Medtronic said. Over two years, a contract research organization will analyze about 125,000 patient records at 250 U.S. cardiology practices. IMPROVE HF is designed to capture the current state of care for Americans with heart failure, provide educational tools to clinicians to close identified treatment gaps, and measure the effectiveness of those tools. Separately, Medtronic reported FDA approval of the Xcelerant Delivery System for use with the AneuRx AAA Stent Graft System. The AneuRx AAA Stent Graft System, approved for U.S. use in 1999, is used in the treatment of abdominal aortic aneurysms (AAAs). The Xcelerant Delivery System provides physicians with a smooth, controlled and more trackable delivery platform to implant the AneuRx AAA stent graft. The delivery system's intuitive, integrated handle contributes to precise placement of the stent graft. The system includes a distal radiopaque marker that improves the visibility of the device when viewed through angiography for more accurate deployment of the stent graft. Medtronic said it anticipates full market release of the Xcelerant Delivery System with the AneuRx AAA Stent Graft System in 1Q05.

Medtronic Sofamor Danek (Memphis, Tennessee) reported the commercial release of the Catalyst Anterior Instrument Set, designed to enable surgeons to more accurately place spinal implants from an anterior surgical approach. The Catalyst Instrument Set uses a ramp-like inserter that separates the vertebrae, delivers the spinal implant to restore normal disc height and removes the inserter all in one step to place a variety of Medtronic spinal implants. The company said the Catalyst Set offers advantages over other sets: the small size of the inserter provides for less invasive incisions; the spinal implant is advanced down ramps via a threaded mechanism, reducing impaction stress on the implant; and distraction of the vertebrae, accurate placement of the implant and removal of the instruments are all achieved in one step.

Medweb (San Francisco) reported the availability of its single-click reconstruction feature designed to improve the turnaround time for 3-D imaging construction, provide more intuitive diagnostic tools and improve upon patient care by decreasing time to diagnosis. MedwebVC is a 3-D virtual colonoscopy application that features the latest advances in 3-D analysis and visualization of medical data. The single-click reconstruction feature allows physicians faster reconstruction of 3-D images by eliminating the multiple steps characteristic of other solutions. MedwebVC features include automatic fly-through mode, automatic colon segmentation, automatic centerline extraction, interactive navigation, synchronized 2-D/3-D windows, 3-D polyp measurement tool, interactive colon model window, multiple colon segment support, integrated reporting and AVI movie creation

Misys Healthcare Systems (Raleigh, North Caro- lina) reported the release of Misys EMR 7.0. The flexible, content-rich electronic medical records solution expedites recordkeeping processes and enables physicians to retrieve and input patient data from a PC, handheld tablet or wireless device. The modularly designed product part of the Misys Optimum family of solutions provides a wireless point-of-care solution for physicians in the examination room, as well as electronic capabilities for routine tasks. New features in Misys EMR 7.0 include medical diagrams, formularies, specialty-specific content libraries, voice capture and an HIPAA security audit trail.

Nanogen (San Diego) said it was issued U.S. patent No. 6,821,729, "Device for Molecular Biological Analysis and Diagnostics Including Waveguides." The patent covers methods and technologies for coupling optical waveguides with a DNA microarray used for performing biological operations and illuminating it at an angle that allows the size and complexity of the diagnostic instrument to be reduced.

Norwood EyeCare (Duluth, Georgia), a subsidiary of Norwood Abbey Ltd. (Melbourne, Australia), said it has begun a three-month study of post-operative comfort, visual recovery and wave-front guided custom ablation with its Centurion SES Epikeratome with EpiEdge for Epi-LASIK in the surgical treatment of myopia. Norwood's bladeless Epi-LASIK technology provides the benefits of LASIK but is designed to reduce or eliminate stromal flap complications as well as the risk of LASIK-induced dry eye, potentially facilitating faster recovery and less postoperative pain. A maximum of 35 patients (up to 70 procedures) will be enrolled at each of the three U.S. study sites.

Quinton Cardiology Systems (Bothell, Washington) has started shipping the Q-Stress version 3.5 cardiac stress testing system. Quinton said its latest software version delivers clinical and ease-of-use advantages, while providing clinicians with advanced cardiac analysis tools.Its enhancements include FreezeFrame, a tool that allows clinicians to perform in-test electrocardiogram (ECG) analysis by continuously storing and displaying vital information for study and archiving during the test; and Cardiac Risk Scoring, a feature using standardized scoring metrics to help predict the likelihood of future heart attacks.

Siemens Hearing Instruments (Piscataway, New Jersey), a leader of wireless synchronization in hearing technology, reported the availability of Acuris, which it called the "world's most technologically advanced binaural hearing system" for the more than 28 million Americans with hearing loss. Acuris' ear-to-ear (e2e) wireless technology enables the left and right hearing instruments to communicate with one other and function as a single binaural hearing system, thereby, the company said, creating a level of synchronization never before possible in hearing instruments. Included within all Acuris models, e2e wireless synchronizes the system's advanced digital processing and wearer controls. "Previously, individuals wore two hearing instruments that functioned independently of each other which lead to additional effort on the wearer's part," said Thomas Powers, chief research officer at Siemens Hearing Instruments. "Acuris is the first truly binaural hearing system because the instruments in both ears communicate and exchange vital information to optimize instrument settings, such as volume control and listening program, for the wearer's listening environment," he told BBI. Powers said that about 80% of people with hearing loss would benefit from hearing instruments in both ears. Of that number, he said that about 75% currently have two monaural (one-eared) devices.

St. Jude Medical (St. Paul, Minnesota) received FDA approval to add V-V (ventricle to ventricle) timing to new models of the St. Jude Medical Epic HF and Atlas+ HF family of cardiac resynchronization therapy devices (CRT-Ds). The company said it believes it is the first CRT-D supplier in the U.S. market to offer this expanded programmability. Shipments began last month. V-V timing refers to the delay between contraction of the left and right ventricles, compared with simultaneous pulses to both left and right ventricles. The V-V timing feature in the Epic HF and Atlas+ HF CRT-Ds allows physicians to adjust the delay between ventricular outputs, as well as choose which chamber is paced first. St. Jude said patients who don't respond to simultaneous biventricular pacing systems may benefit from the sequential timing of V-V.

Syneron Medical (Yokneam, Israel) reported that the FDA has granted 510(k) clearance to its Comet and Polaris DS systems for permanent hair reduction on all skin types, including tanned skin. This new approval expands on the FDA's earlier clearance for hair reduction for these systems. Comet and Polaris DS are based on the same form of Syneron's ELOS (electro-optical synergy) technology. Both systems combine electrical energy (bi-polar radio frequency) and diode laser energy to enable efficient, safe, long-lasting treatment of unwanted hair from all skin types and all parts of the body.

Trinity Biotech (Dublin, Ireland) reported that the FDA has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 for the Uni-Gold Recombigen HIV test. The waiver means that the test can now be used by almost 200,000 test sites including physician's offices and clinics in addition to its previously approved applicability in the hospital environment, the company said. The Uni-Gold Recombigen HIV test is approved by the FDA for the detection of antibodies to HIV in human serum, plasma, venous and finger stick whole blood and is the only rapid HIV test to be approved for use with all four sample types. The test requires only one step and produces a result within 10 minutes.

TriPath Imaging (Burlington, North Carolina) said that data generated from in-house research studies of an early version of its formulation of multiple biomarkers demonstrated a sensitivity of 93%, a specificity of 92%, a negative predictive value of 97%, and a positive predictive value of 79% for biopsy-proven moderate-to-severe cervical dysplasia in a retrospective cohort of cervical samples. These and other data relating to the performance of individual biomarkers support the potential clinical utility of the use of biomarkers for the detection of cervical dysplasia and cancer.

VisiJet (Irvine, California) has begun offering a third alternative called the Epi-LASIK System for a refractive surgery technique in ophthalmology that it says combines the best aspects of the most popular refractive surgeries, LASIK (laser in situ keratomileusis) and PRK (photorefractive keratectomy), making it a safer choice for surgical vision correction. Unlike other procedures, the Epi-LASIK System does not require a surgeon to cut the patient's cornea or apply alcohol. The system received 510(k) clearance in late September and the company has begun marketing the product in the U.S. and internationally. With Epi-LASIK, a surgeon simply slides back the epithelial layer of the cornea, does the ablation, and puts the layer back in place, keeping it intact and creating the effect as a living contact lens. Units have begun shipping in the U.S. and more than 20 other countries, including Japan, Korea and all the major European market countries.

Vivant Medical (Mountain View, California) and Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina) reported completion of an "ablate and resect" study to determine the effectiveness of microwave ablation for treatment of renal tumors. In the study, Wake Forest used Vivant's VivaWave Ablation System, which is FDA-cleared for coagulation of soft tissue.

Zimmer Holdings (Warsaw, Indiana) reported the launch of Minimally Invasive Solutions (MIS) Quad-Sparing TKA (total knee arthroplasty), one of the least-invasive and first widely available minimally invasive knee replacement procedures, along with a consumer education program to help patients understand differences between various types of minimally invasive joint replacement surgery. Zimmer MIS Quad-Sparing TKA is a surgical approach that entirely spares the quadriceps muscle and tendons. The MIS technique involves the use of special instrumentation and a modified surgical technique to place the same implants used in traditional knee MIS replacement surgery, but through a much smaller incision.