A new device developed by Medtronic MiniMed (Northridge, California) may be the next step in the evolution toward the first true artificial pancreas for diabetes sufferers. The device, called the Guardian Continuous Glucose Monitoring System, was cleared last month by the FDA and is designed to protect diabetes patients by alerting them to potentially dangerous fluctuations in blood sugar (glucose) levels. By sounding an alarm when glucose levels become too high or too low, the system warns patients to take action to normalize their blood sugar, which can result in improved health and quality of life. Unhealthy blood sugar fluctuations can cause long-term complications, such as blindness, kidney failure, amputation, impotence and heart disease, as well as loss of consciousness or even death.

"Each year, thousands of children with nighttime hypoglycemia, or low blood sugar, and adults who are unaware that they have hypoglycemia, are at risk of serious complications and death due to having low blood sugar," said Jeffery McCaulley, vice president and general manager of Medtronic's Diabetes business. "For these patients and their families, the Guardian system represents a major improvement in the management of diabetes and peace of mind."

The Guardian system is an external device that utilizes a glucose sensor to continuously record blood sugar readings for up to three days. These glucose readings are transmitted to the monitor, which is designed to sound an alarm when blood sugar levels reach high or low limits pre-set by the patient or healthcare professional. Information from the system's monitor can be downloaded to a computer for additional trend analysis to further improve diabetes care. The system requires a physician prescription and is calibrated a minimum of twice a day using a discrete blood glucose meter.

Company spokesperson Deanne McLaughlin said the Guardian is designed for "any Type 1 or Type 2 patient [who] desires better control." She told The BBI Newsletter that the company believes that there are two probable initial target markets for the device, one being children. "Parents are very concerned; they're waking up every night wondering what's going on with their kids." The other initial group, she noted, is patients "that have had super erratic fluctuations, that have passed out [or] have had accidents [who] can't detect when they're going low."

Not only is the Guardian system an important "stand-alone" tool for patient use, but according to the company, the system is an integral component in its diabetes technology pipeline. "We are making excellent progress on our near-term strategy of integrating Guardian sensor technology with a next-generation Paradigm pump, as well as our longer-term strategy that includes the development of advanced algorithms to create an artificial pancreas," said Scott Ward, senior vice president and president of Medtronic's Neurological and Diabetes business, in a statement. McLaughlin agreed with Ward's assessment. "It's an important step forward," she said, noting that the company intends to take a future Paradigm pump and integrate it with the Guardian to develop the world's first continuous glucose monitoring system. "This is not only a stand-alone product but it's a pivotal point in our product milestone moving forward."

The company said the approval of the Guardian system represents the latest in a series of technology advancements from Medtronic Minimed's pipeline, including the Paradigm 512 and 712 insulin pump systems and CGMS System Gold, a physician-use continuous glucose monitoring system. The company also recently introduced the industry's first technology pathway program, allowing Paradigm pump users to remain at the forefront of technology advancements by upgrading to Medtronic's integrated insulin pump systems as they become available.

Elsewhere in the product pipeline:

Afferent (Providence, Rhode Island) reported publication of research results pertaining to use of its technology in treating nerve dysfunction stemming from diabetes. Performed in collaboration with Aristidis Veves, MD, DSc, director of the Joslin-Beth Israel Deaconess Foot Center (Boston, Massachusetts), the study showed that prototypes of the company's non-invasive neural stimulation devices improved sensitivity to touch on the feet of diabetic subjects with reduced nerve function. Appearing in the December issue of the clinical journal Diabetes Care, the findings have implications in lowering the incidence of dangerous foot ulcers in these individuals, the company said. In this pilot clinical study, supported by a research grant from the National Institutes of Health (Bethesda, Maryland), 20 subjects with moderate-to-severe peripheral neuropathy received subsensory vibratory mechanical stimulation delivered to the sole of the foot in a series of trials. Changes in touch sensitivity were measured using standard neurological exams: Semmes-Weinstein monofilaments and a vibration perception threshold test. The presence of the stimulation significantly improved subjects' ability to detect small pressures and vibrations, on average by 20%.

Beahm Designs (Campbell, California) unveiled the VS810A, a shrinking and laminating machine designed to advance the yield of productivity for medical device manufacturers. Tube laminating, also referred to as shrinking, is a technique used by medical device engineers in the catheter manufacturing process. The VS810A automates the process and enables catheter manufactures to process up to four catheter shafts simultaneously at lengths up to 71" (180 cm), substantially increasing productivity. Additionally, the VS810A enables the processing of multiple speeds and lengths within a single process cycle and allows for a wide range of traverse lengths and speed settings through a simple operator key pad.

Bioject Medical Technologies (Bedminster, New Jersey) reported completing a Phase I clinical study comparing its Iject pre-filled, needle-free drug delivery system to the traditional needle and syringe. Sponsored by Bioject, the study was performed at a third-party organization, Comprehensive Phase One. Subcutaneous injections of 0.5 ml of saline were administered to 60 healthy volunteers in the triceps, the abdomen, or the thigh. Each subject received two injections, one with the standard needle-and-syringe on one side and an injection with the Iject on the other. Subjects were then asked to compare the injections with regard to pain, tolerability and preference. Results indicated that the Iject pre-filled, needle-free injection device was less painful and easier to use than the needle and syringe.

Biomet (Warsaw, Indiana) reported the FDA clearance of Palacos G antibiotic-loaded bone cement. Bone cement is a grout used to secure artificial implants to bone. Palacos G bone cement is comprised of standard Palacos bone cement with the addition of Gentamicin. Cleared for use in the second stage of a two-stage revision, Palacos with Gentamicin has been the standard of care in Europe for nearly 35 years, Biomet said.

Biosite (San Diego, California) received clearance from the FDA to market the Triage BNP Test for Beckman Coulter Immunoassay Systems, a diagnostic test that measures B-type natriuretic peptide (BNP). The Triage BNP Test for Beckman Coulter (Fullerton, California) immunoassay systems, launched in Europe last year, is now available to customers in the U.S. through Biosite's direct sales force and Fisher Healthcare (Hampton, New Hampwshire). Beckman Coulter will manufacture the test for Biosite, and Biosite will exclusively sell and market the product. Designed to provide results standardized to match Biosite's existing rapid, portable Triage BNP Test, the newest BNP test has received FDA clearances for use in the diagnosis of congestive heart failure, assessment of disease severity and for the risk stratification of patients with acute coronary syndromes, all of which apply regardless of the system on which the test is performed.

Boston Scientific (Natick, Massachusetts) said it has received the CE mark for its new coronary stent, the Liberte. The company planned to launch the stent immediately in Europe and other international markets, and in the U.S. in the second half of 2004. Boston Scientific said the Liberte stent will serve as the platform for its next-generation drug-eluting stent system. It said it plans to file an investigational device exemption with the FDA for clinical trials of its next generation drug-eluting stent system in the first half of 2004.

Cepheid (Sunnyvale, California) reported being issued U.S. patent No. 6,664,104, "Device incorporating a microfluidic chip for separating analyte from a sample," covering the design of a sample preparation cartridge containing a microfluidic chip for extraction and purification of multiple DNA targets simultaneously. The technology enables the integration of Cepheid's automated cartridge sample preparation capability with a high number of genetic targets, with improved nucleic acid capture and concentration efficiency, using solid-state components. The patent enables the development of a microfluidic chip that has an array of high-aspect ratio microstructures, providing a large surface area for the capture and concentration of an analyte. In use, a sample containing nucleic acid is forced to flow through a cartridge that contains the extraction chip so that the analyte in the sample binds to the pillars while unwanted sample components flow through the chip and into waste.

ChromaVision Medical Systems (San Juan Capistrano, California) said that the FDA cleared for marketing its ACIS system to perform tests used to help physicians determine an appropriate course of treatment for breast cancer patients. The ACIS is the first imaging device cleared to detect, count and classify the presence of the HER2 protein, giving physicians a more precise and quantitative understanding of the specific traits of individual cancer tumors. The company said this FDA clearance allows ACIS to be used as a complement to the DakoCytomation HercepTest in the detection and measurement of Her2/neu. This specific clearance is intended to enable broadened marketing and promotional efforts and provide the company with the ability to make specific claims as to the prognostic and predictive value of ACIS, the company said.

dj Orthopedics (San Diego, California) introduced a new ambulatory pain management system designed to control postoperative pain. The DonJoy Pain Control Device (PCD) is a portable, disposable pump that continuously delivers physician prescribed local anesthetic directly into a surgical site over an extended period of time to manage postoperative pain. dj Orthopedics will market the new device in a sterile kit throughout the U.S. and Canada where the company has exclusive distribution rights for all surgical applications. The DonJoy PCD consists of a new pump manufactured by McKinley Medical (Wheat Ridge, Colorado), which incorporates a latex-free disposable system, integrating a proprietary syringe reservoir with a mechanical driver. The DonJoy PCD also features convenient gradient markings on the pump enabling medical personnel and patients to monitor the amount of local anesthetic that has been administered, a feature not found on elastomeric balloon pumps. The DonJoy PCD will be available initially in two reservoir volumes, 100 mL and 275 mL, with multiple flow rates for continuous infusion of up to five days.

Exactech (Gainesville, Florida) received FDA clearance for distribution of what it said is the only pre-formed cement hip spacer containing an antibiotic available in the U.S. The pre-formed InterSpace hip spacer is a major advancement in treating patients suffering from the complication of infected total hip arthroplasty, the company said. Used in two-stage revision hip surgery, it provides the orthopedic surgeon with a new method for a more effective and efficient surgical procedure. The spacer allows for consistent and uniform release of antibiotic into the local infected area. It also offers patients the opportunity for improved function after the first stage treatment and better rehabilitation after the definitive second stage operation. InterSpace is manufactured by Tecres SpA (Verona, Italy) and distributed in the U.S. exclusively by Exactech.

Fluke Biomedical (Carson City, Nevada), a manufacturer of medical test equipment, in conjunction with Hart Scientific (American Fork, Utah), a developer of temperature calibration products and services, unveiled a new digital temperature and humidity logger for ultra-accurate recording of environmental conditions in critical locations such as calibration and research labs, pharmaceutical and chemical storage areas and many medical environments. The Model 5020A the DewK accepts inputs from up to two sensors, which may be mounted directly on the unit or remotely (up to 50 feet away). Each sensor comes calibrated for temperature and humidity from Hart Scientific and contains its own calibration data so recalibration doesn't require the DewK itself. Daily statistical summaries are automatically maintained. All functions, display and system settings are easily changed using the DewK's secure password-protected menu system.

Gen-Probe (San Diego, California) received FDA approval for the Aptima Vaginal Swab Specimen Collection Kit, the first kit that enables patients to self-collect vaginal swab specimens to be tested for Chlamydia trachomatis and Neisseria gonorrhoeae using the Aptima Combo 2 assay. The Aptima Combo 2 assay is used to test specimens from both symptomatic and asymptomatic individuals to aid in the diagnosis of sexually transmitted diseases caused by C. trachomatis and N. gonorrhoeae.

Guidant (Indianapolis, Indiana) has launched its Acrobat SUV (Swivel, Universal, Vacuum) Stabilizer System for beating-heart surgery. The Acrobat SUV Stabilizer System is the next-generation addition to the established Acrobat line of stabilization devices. The system is designed to provide optimal stabilization and visibility during coronary artery bypass graft (CABG) surgeries. Stabilization devices such as the Acrobat SUV provide surgeons with the ability to perform CABG while the heart is still beating, eliminating the need for a heart-lung machine. The system includes the Acrobat Stabilizer and the Xpose Access Device, which is designed to lift the heart, allowing the surgeon to position and access blood vessels.

Isotechnika (Edmonton, Alberta) is developing a test called Diatest, a breath test that would measure insulin resistance. "People, because they're supersizing their Big Macs and everything else, are becoming more obese, they're exercising less, [and] we have an aging population. Diabetes is the fastest-growing disease in China, for instance," Joseph Koziak, executive vice president, told BBI's sister publication, Medical Device Daily. "It's an obvious [test] to go with, because this is really the first test that can act as a precursor to tell you, 'Listen, you don't have diabetes right now, but if you continue with your current exercise and diet [regimen], you have the potential to become diabetic in the very near future.'" And that's the test's importance it can predict what is likely to happen in the future. Koziak said, "The benefit of this test is the fact that it's a predictor, and that's why we think it will be successful in the market " The hope is that Diatest will be used at the physician's office much the same way a cholesterol test is used today, as a way to determine how well a patient is doing, and how that individual's condition might have improved or worsened with the use of diet, exercise or therapeutics compared to baseline results. The test involves taking a reference breath sample, and then the patient uses an oral solution of carbon 13 load, and a second sample is taken an hour-and-a-half later. Koziak said that a normal person would have a certain level of carbon dioxide in his or her breath, while a person who is impaired with insulin resistance would have a diminished level. Isotechnika hopes to have the test available to primary care physicians in Canada, where the test is approved, by late this year. The company expects to get studies under way over the "next year or so" toward the goal of regulatory approval in the U.S.

Masimo (Irvine, California) reported the launch of SPO2.COM, a new division that manufactures pulse oximetry sensors for conventional Nellcor (Pleasanton, California) sensor-compatible pulse oximeters. SPO2.COM produces a full line of low-cost pulse oximetry sensors and patient cables for use with conventional Nellcor sensor-compatible pulse oximeters. The sensors, although similar to conventional sensors, incorporate the Masimo-patented LNOP recessed photo detector for greater motion, electrical and ambient light rejection.

Medtronic (Minneapolis, Minnesota) reported FDA clearance and U.S. commercial release of the Medtronic EnPulse pacing system. The new system incorporates an enhanced suite of features to help physicians better manage patients with slow heart rhythms and streamline the patient follow-up process, the company said, including Search AV +, an automatic and expanded search method that senses the patient's natural heartbeats before delivering pacing therapy; Quick Look II screen, which allows clinicians to instantly access complete information about the patient's heart rhythm and pacemaker activity on a single, easy-to-understand screen; and Ventricular Response Pacing, a specialized form of pacing that may help the ventricles contract with a regular rhythm. The EnPulse dual-chamber devices can be upgraded with new therapies, allowing for forthcoming enhancements that in the future could be enabled without patient surgery through a programmer software upgrade, Medtronic said. Separately, Medtronic said that it has begun the distribution of the Medtronic Paceart System 2004 First Edition to help clinics that specialize in heart rhythm disorders improve the electronic organization of cardiac device and patient heart rate data. The new release expands the accessibility of data managed within Paceart by providing an electronic interface between the Paceart system and an array of healthcare information systems. The new export module uses XML and PDF standards for data transmission and formatting, which enables broad compatibility with and access from other systems.

Miravant Medical Technologies (Santa Barbara, California), which specializes in PhotoPoint photodynamic therapy (PDT), said the FDA has granted orphan-drug designation to PhotoPoint MV2101, its drug candidate for the prevention of hemodialysis access graft disease in patients with new vascular grafts. PhotoPoint PDT is a minimally invasive medical procedure using a light-activated drug to selectively target diseased cells and blood vessels.

OmniCorder Technologies (East Setauket, New York) reported the addition of a new infrared sensor patent, titled "Dual Band Focal Plane Array." The patent was granted to scientists developing the new generation of Quantum Well Infrared Photodetector (QWIP) infrared sensors at NASA's Jet Propulsion Laboratory (Pasadena, California) and at the Army Research Laboratory (Adelphi, Maryland). The patent was assigned to the California Institute of Technology (Caltech; also Pasadena). OmniCorder Technologies owns the exclusive worldwide rights to this and other infrared sensor patents, for biomedical applications, through a license agreement with Caltech. QWIP sensor technology is used in the BioScanIR System, the company's medical imaging product that detects diseases that affect changes in blood perfusion.

Osteotech (Eatontown, New Jersey) said the March 15 issue of Spine would report on the first prospective randomized clinical trial conducted with a demineralized bone matrix in a carrier, Grafton Demineralized Bone Matrix (DBM) Gel. The use of the patient's own bone, typically obtained from the iliac crest, to aid in achieving a solid fusion of the vertebrae has been the "gold standard" in spine surgeries. The study, which was conducted at seven U.S. medical centers involving 120 patients, demonstrated that Grafton DBM Gel, when combined with one-third the amount of iliac crest bone, was equivalent to the use of iliac crest bone alone in achieving lumbar spine fusions.

Quest Products (Libertyville, Illinois) said Ovulation Scope, a reusable at-home ovulation test, is now available at retail stores nationwide. When a woman ovulates, her estrogen levels increase as well as the salt levels in her saliva. When a saliva deposit is placed on the Ovulation Scope, the salts will form a ferning pattern within 10 minutes indicating with about 98% accuracy if she is in a fertile period of her menstrual cycle.

Radiancy (Orangeburg, New York) reported that the FDA has granted clearance to market the company's ClearTouch Light Unit Assembly (LUA) for the treatment of acne vulgaris. This Radiancy technology "becomes the first light-based therapy in the world to be indicated for the treatment of pustular inflammatory acne," the company said. The ClearTouch LUA expands the treatment applications available with Radiancy's phototherapy systems. ClearTouch delivers penetrating green-yellow light that activates a photothermal reaction in the porphyrin molecules, causing the release of free oxygen to destroy P. acnes bacteria. Direct heat delivered to the skin accelerates the photothermal reaction and bacteria destruction. Pulsed light in the red spectrum further activates the porphyrin, and also helps reduce the inflammation associated with active acne.

Refocus Group (Dallas, Texas) received FDA approval to begin Phase II clinical trials of the company's Scleral Implants and Scleral Spacing Procedure (SSP) for the surgical treatment of presbyopia. The SSP procedure uses four Scleral Implants, which are surgically implanted just under the surface of the sclera (white of eye) in four quadrants. The FDA approval is conditioned on the company's submittal of certain final documentation concurrent with the initiation of the clinical study. The Phase II clinical trial will be a multi-center, randomized study, with 100 patients receiving SSP and another 50 patients designated as control patients. Refocus Group has approval to begin immediate enrollment of patients for the clinical trials in up to 10 clinical sites within the U.S.

Roche Diagnostics (Basel, Switzerland) reported the launch of its new Factor V Leiden Kit and Factor II (prothrombin) G20210A Kit for its LightCycler real-time polymerase chain reaction instrument. Both tests allow the detection and genotyping of inherited mutations in the genes that encode the Factor II and Factor V proteins, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. Inherited thrombophilia predisposes an individual to thrombotic events such as venous thrombosis, the third most common cardiovascular disease. The kits received 510(k) clearance under an accelerated review process from the FDA, and also bear the CE mark, allowing distribution within the European Union. "The clearance for these types of tests increases access to genetic testing technology important for today's blood clotting mutation identification and opens the door to future advances using Roche's MagNA Pure and LightCycler products," said Heino von Prondzynski, head of Roche Diagnostics.

SoftMed Systems (Silver Springs, Maryland) reported a productivity enhancement to ChartScript, its medical transcription software. ChartScript Express is a word-processing option designed to streamline transcription operations. The new feature is simple and intuitive, speeding the transition from document creation to actual transcription. The ChartScript Express option offers a simplified typing field and document set-up process. It also incorporates tools for efficient and accurate document creation, including an interface similar in appearance to a standard text editor for data entry. SoftMed said it estimates that training time will be cut in half with the use of ChartScript Express.

Texas Instruments (Tucson, Arizona) reported rollout of an eight-channel, low-noise, variable gain amplifier from the company's Burr-Brown product line, designed for medical and industrial imaging applications. The VCA8613 incorporates eight low-noise preamplifiers, eight attenuators and eight post-gain amplifiers. Normally, this functionality and integration would demand substantial power, but the VCA8613 draws only 600mW (75mW/channel), making it the lowest-power solution available on the market today, according to the company. The VCA8613 features an integrated continuous wave (CW) processor that allows a reduction in the number of external components required to support the CW Doppler mode (critical in cardio scanning applications). Texas Instruments provides DSP and analog technologies to meet real world signal processing requirements.

TIAX (Cambridge, Massachusetts) reported receiving a U.S. patent for a multi-layered wound dressing designed for faster, more effective healing of hard-to-heal wounds. The dressing consists of three layers of non-woven materials, each of which has a separate function in the healing process. The contact layer protects the vulnerable, afflicted area while allowing oxygen to reach the wound. The second layer wicks and transports wound fluid away from the wound and can act as a depot for topical drug delivery. The third layer allows air to enter, moisture vapor to escape and is waterproof. TIAX said it is seeking a partner in the wound care industry to manufacture the dressing for commercialization in the U.S. market.

Trinity Biotech (Dublin, Ireland) received FDA approval to market its Uni-Gold Recombigen HIV test in the U.S. The product is approved for the detection of antibodies to HIV in human serum, plasma or whole blood and is the first device to be approved for use with all three sample types, the company said. Uni-Gold Recombigen HIV produces a result within 10 minutes, whereas results may not be available for hours with conventional laboratory tests. Uni-Gold Recombigen HIV was approved by the FDA on the basis of clinical trial results on over 9,000 patient specimens where the product demonstrated a test sensitivity of 100% and a specificity of over 99.7%.

Vascular Solutions (Minneapolis, Minnesota) received 510(k) clearance from the FDA for its Pronto extraction catheter. The Pronto device is indicated for use in the removal of soft thrombus from vessels in the arterial system. Howard Root, chief executive officer, said, "We believe that there is a substantial market opportunity for a simple mechanical extraction system for the removal of fresh thrombus." The Pronto consists of an extraction catheter with a proprietary atraumatic distal tip and large extraction lumen that can be percutaneously inserted into arteries to remove soft thrombus. A syringe extraction system allows for single-operator deployment, with total preparation and deployment time of less than two minutes. The Pronto extraction catheter was initially developed by Dr. Pedro Silva of Milan, Italy, who exclusively licensed it to Vascular Solutions.

Welch Allyn (Skaneateles Falls, New York) introduced two new multi-channel electrocardiographs (ECG), the Welch Allyn CP 10 and CP 20. Both units are battery operated and feature alphanumeric keyboards for easy entry of patient demographics, full-size user programmable reports that print on thermal paper, and advanced filters for optimal ECG trace quality. The more sophisticated CP 20 offers the option of connecting with many electronic medical record systems through the Welch Allyn CardioPerfect Workstation software. The Welch Allyn CP 10 offers non-interpretive 12 lead resting ECG with ECG measurements standard and an LCD screen for easy patient data entry. The Welch Allyn CP 20 boasts the same easy-to-use operation and functionality as the CP 10, but also features an eight-channel ECG preview screen, and storage and transmission capability for up to 50 ECGs.