St. Jude Medical (St. Paul, Minnesota) reported receiving FDA approval and European CE marking, as well as the first implant of its Atlas Plus implantable cardioverter defibrillator (ICD), which it said is the highest output (36 joules delivered/42 joules stored) rate-adaptive device on the market. High-energy outputs are particularly helpful in patients who have life-threatening high or rising defibrillation thresholds, the company said. Competitor Medtronic (Minneapolis, Minnesota) received an approval in October for its own high-output ICD, the Maximo, which is built on the platform of its Marquis ICD and is capable of producing 35 joules of delivered energy. The FDA initially approved St. Jude's Atlas family of ICDs in January 2002.
Drs. Neal Lippman and Joseph Dell'Orfano performed the first implant of the new ICD in a 44-year-old male patient at St. Francis Hospital (Hartford, Connecticut). "It's impressive to find such high-energy output in a small, physiologically-shaped ICD that is adaptable to numerous patient conditions with excellent therapeutic efficiency," Lippman said. Dell'Orfano added, "The high-voltage lead integrity test and comprehensive summary screen expedite implantation by providing essential threshold and impedance data at a glance."
"In addition to being the world's most powerful rate-adaptive ICD, the Atlas Plus ICD provides advantages over conventional high-energy devices without compromising size or longevity," said Michael Coyle, president of St. Jude's Cardiac Rhythm Management business. "In addition, the Atlas Plus DR includes AF Suppression technology and AutoIntrinsic Conduction Search, giving physicians an opportunity to provide ICD therapy to a broad array of patients with complex co-morbidities and concomitant drug therapies."
Peter Gove, vice president of corporate relations, said, "Now we are adding AF Suppression to both the Epic and the Atlas, so the Atlas Plus is the Atlas plus the AF Suppression algorithm." The Epic is St. Jude's top-of-the-line smaller ICD and the Atlas is its top-end high-power ICD. "We've added AF Suppression, which prior to that had been in our all of our pacemakers. We've now added [it] to our standard ICDs," he said. Gove said the approval was a simple matter for U.S. regulators. "For the FDA, this is a supplement of software and hardware they previously approved, so there was no need for an IDE [investigational device exemption] on this."
Aside from the AF Suppression algorithm, Atlas Plus ICDs incorporate a set of tachycardia and bradycardia features, including:
AutoIntrinsic Conduction Search (positive AV/ PV hysteresis) to promote the heart's natural AV synchrony and reduce unnecessary RV pacing that may exacerbate the onset of heart failure, as shown in the landmark DAVID (Dual-Chamber And VVI Implantable Defibrillator) clinical trial sponsored by St. Jude.
Programmable waveforms and shocking vectors to give physicians greater flexibility to address individual patient needs for life-saving cardioversion and defibrillation therapy, which may eliminate the need for additional surgical procedures.
Auto Sensitivity Control, designed to eliminate oversensing without adjusting maximum sensitivity levels, which can compromise the device's ability to detect dangerous low-amplitude fibrillation.
AV Rate Branch (dual-chamber model only) and Morphology Discrimination to help reduce the risk of inappropriate shocks while promoting fast diagnosis and delivery of therapy.
St. Jude also reported 10-year clinical data for its Toronto SPV stentless tissue heart valve as part of a post-approval clinical study required by the FDA. The study followed 447 patients at six centers in the U.S. and Canada from July 1991 until October 2002. Key findings included "excellent" ratings on durability, patient valve-related survival rates and clinical performance. The data also showed a statistically significant improvement in left ventricular mass regression between the early and late postoperative visits and showed that patients experienced a statistically significant decrease in pressure gradients in all valve sizes between the early and late postoperative visits.
Elsewhere in the product pipeline:
Alara (Hayward, California) received 510(k) clearance from the FDA to market its CRystalView desktop computed radiography (CR) system. The CRystalView system uses storage phosphor technology to replace film in conventional medical X-ray systems and provides high quality digital images at an affordable price. The system automatically unloads, scans, erases and re-loads the storage phosphor imaging plate. Scanner throughput is in excess of 50 plates/hour for 14" x 17" cassettes in standard resolution. The CR reader is a desktop, network scanner that can accommodate up to four quality control workstations operating simultaneously.
Alsius (Irvine, California), has received 510(k) clearance from the FDA to market its ICY and Fortius catheters in combination with the company's CoolGard 3000 Thermal Regulation System. The products are indicated for use in cardiac surgery to achieve and/or maintain normothermia during surgery and recovery/intensive care, and in neurosurgery to induce, maintain and reverse mild hypothermia in surgery and recovery/intensive care. The catheters feature heat exchange balloons in which cool or warm sterile saline continuously flows in a closed-loop fashion and the CoolGard system remotely senses changes in patient temperature and adjusts the temperature of the sterile saline flowing within the balloons as needed. The effects of anesthesia and cool temperatures in the operating room during cardiac surgery often create an undesired drop in patient temperature. Shivering places additional strain on already damaged heart muscle and has shown to have a negative impact on a patient's length of stay in the hospital. And patients routinely are cooled three or four degrees below normal temperatures during neurosurgical repair of aneurysms to protect the brain tissue during the operation. The cooling is followed by actively rewarming the patient back to normal temperature at the end of the procedure to prevent post-operative complications.
AngioDynamics (Queensbury, New York) reported the release of the AquaLiner hydrophilic Ni-Ti alloy guidewire for sale in the U.S. The AquaLiner guidewire has a hydrophilic coating, which helps reduce friction when the guidewire comes into contact with fluids. This feature allows a physician to move the guidewire through vessels and catheters with greater ease, simplifying guidewire placement in endovascular procedures.
Artemis Medical (Hayward, California) reported the commercial release of two new technologies, the CorMARK Breast Biopsy Identifier and the SkiPOLE Breast Localization Needle that will more precisely and accurately diagnose and treat breast cancer. Designed to be placed after a core needle biopsy, the CorMARK enables physicians to accurately and precisely landmark the site of the biopsy in the event surgical intervention is necessary. The CorMARK is the only product available that provides physicians a single collagen MARK with a titanium clip that can be imaged using ultrasound, mammography or magnetic resonance imaging. The SkiPOLE Breast Localization Needle is placed by radiologists to provide an accurate guide for surgeons performing breast conserving therapy or open excisional biopsy. The SkiPOLE will remain securely in position due to the 3-D anchoring basket that deploys within the breast tissue.
ArthroCare (Sunnyvale, California) has begun U.S. market rollout of several recently approved products that it said offer faster, more efficient and more complete tissue removal for shoulder, anterior cruciate ligament, meniscus and cartilage repair. The new products include three new ArthroWands the UltraVAC, Paragon and MeniVAC plus the new Atlas control system and the Bilok ACL anchor. The Atlas System Controller is ArthroCare's new platform for enhancing its Coblation technology's performance in arthroscopy, and the UltraVAC is the first wand designed for the Atlas system. The Paragon ArthroWand was designed in conjunction with the University of Pittsburgh (Pittsburgh, Pennsylvania) and is expected to provide surgeons with a viable alternative for the removal of damaged or degenerative cartilage. The MeniVAC ArthroWand enables effective smoothing and contouring of the meniscus in the knee using a multi-electrode design featuring 21 independent electrodes arrayed in a precise geometric pattern. The Bilok for ACL fixation is the first product to come out of a distribution and product development agreement signed with Biocomposites Ltd. in May. ArthroCare said the calcium-based absorbable composite closely mimics the structure of human bone and allows for quick absorption and effective fixation.
Biosite (San Diego, California) has filed a 510(k) submission with the FDA seeking clearance to market the Triage BNP Test for Beckman Coulter (Fullerton, California) Immunoassay Systems. The Triage BNP Test measures B-type natriuretic peptide (BNP), a protein marker for congestive heart failure. The anticipated product is a result of the agreement signed in June for Beckman Coulter to manufacture and Biosite to commercialize the BNP test for use on Beckman's immunoassay systems. Expected to be available in 1Q04, the BNP test will be sold worldwide through a combination of Biosite's direct and distributor sales forces. Designed to correlate to the existing rapid Triage BNP Test run on Biosite's rapid, portable Triage MeterPlus testing platform, the test will be available for use on Beckman Coulter systems including the Access and Access 2 immunoassay systems, Synchron LXi 725 combination chemistry and immunoassay workstation, and the new high-throughput UniCel DxI 800 Access immunoassay system.
Biolase Technology (San Clemente, California), a manufacturer of lasers and related products focused on pain-free medical and dental procedures, said it has obtained the first-ever clearance from the FDA for periodontal procedures for both early and advanced stages of periodontal disease for its 810 nm solid-state laser system, LaserSmile. The new clearances include applications for soft tissue curettage; removal of diseased, infected inflamed and necrosed soft tissue within the periodontal pocket; and removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. The LaserSmile previously had FDA clearance for cosmetic and soft-tissue applications including tooth whitening, cosmetic gingival contouring, crown lengthening, treatment of herpetic lesions and aphthous ulcers, gingival troughing, sulcular debridement in the periodontal pocket and other indications.
Carl Zeiss Meditec AG (Dublin, California) reported the availability of Humphrey Glaucoma Progression Analysis (GPA) software as an upgrade for the Humphrey Field Analyzer (HFA) II and II-i instruments. The software is designed to differentiate true glaucoma progression from random variability in visual field testing, applying the knowledge gained from a multi-center clinical trial, in which the actual test-retest variability of hundreds of glaucoma patients was measured. The Humphrey GPA software provides automatic, plain language interpretation of test results. When significant degradation is seen in three or more points on two consecutive follow-up tests, the software interprets the patterns and automatically alerts the practitioner.
CMS (St. Louis, Missouri), a developer of radiation treatment software, reported that it has received FDA 510(k) clearance for I-Beam, a self-contained mobile patient positioning system that uses ultrasound and other images in the treatment room to confirm the location of target organs or tumors. I-Beam uses a 3-D positioning technology with an integrated camera and free hand ultrasound probe that is registered through a passive localization target inserted in the shadow or wedge tray of any linear accelerator. The technology allows I-Beam to be self-contained, without the need for hardware mounting in the treatment room. Additionally, I-Beam has contouring capabilities that allow for integration into CMS' treatment planning systems.
Corgenix Medical (Westminster, Colorado) has received clearance from the FDA to begin marketing 11 enhanced products for the laboratory diagnosis and risk assessment of blood clotting disorders. The modified test kits detect antibodies to antiphospholipids. High levels of these antibodies have been reported in patients with antiphospholipid syndrome.
dj Orthopedics (San Diego, California) reported the introduction of the UltraSling ER (External Rotation) shoulder brace. The UltraSling ER is the first soft shoulder brace designed specifically to position the shoulder joint in an improved position to promote healing following traumatic shoulder dislocation or shoulder surgery. The brace supports the shoulder joint by positioning the elbow against the hip/rib area with the forearm rotated slightly outward, or externally rotated.
Edwards Lifesciences (Irvine, California) reported completion of a 16-year follow-up of the effectiveness and durability of its Carpentier-Edwards Perimount mitral pericardial heart valve. The data, compiled at seven centers in Europe and Canada, followed more than 430 patients. The report concluded that patients 60 years of age and older who received the valve, which includes biomechanically engineered bovine pericardial tissue, had a nearly 90% chance of not needing a new valve, due to structural valve deterioration, for 16 years. The company said the study also confirms the valve's safety through a low incidence of complications, such as bleeding and thromboembolism. Edwards recently introduced in the U.S. its ultra-low profile Tricentrix holder, designed to offer better visualization and operating space for surgeons implanting the Perimount mitral valve.
EP MedSystems (West Berlin, New Jersey) said its ALERT Companion II has been successfully used in its first routine internal cardioversion case in the U.S. Dr. James Higgins, a cardiologist practicing at Saint Francis Hospital (Tulsa, Oklahoma), said the ALERT system was used for a patient who had failed external biphasic cardioversion several times, "and was anticipating either chronic atrial fibrillaton (AF) or a lifelong regimen of antiarrhythmic drugs. We used the ALERT system, which easily cardioverted the patient back into normal sinus rhythm." The system delivers programmable low-energy, biphasic electrical impulses directly to the inside of a patient's heart to convert atrial fibrillation to a normal rhythm. The electrical impulses are delivered via a specially designed catheter used in tandem with an energy source called ALERT Companion.
Hologic (Bedford, Massachusetts) introduced its new entry-level, fan-beam bone densitometry system, Explorer, at the annual Journees Francaises de Radiologie meeting in Paris. The Explorer system combines Hologic's exclusive OnePass fan-beam technology and Internal Reference System with complete procedure automation, providing an automated, precise solution. Commercial shipment of the system is subject to regulatory approvals including FDA. Fan-beam bone densitometry technology uses a design similar to computed tomography systems. Through the use of a multi-detector array, a 2-D X-ray image is acquired with only a single pass of the detector along the length of the patient. Hologic said that for price-sensitive markets, where conventional bone density testing is preferred over high-end imaging, Explorer offers the speed and precision of fan-beam scanning at a price comparable to older rectilinear scanning systems. Explorer replaces the QDR-4000, Hologic's last rectilinear scanning system.
Lumenis (Yokneam, Israel) reported that its strategic partner, WaveLight Laser Technologie AG (Erlangen, Germany), received FDA marketing clearance for the Allegretto Wave Excimer Laser. The Allegretto Wave is the first refractive laser to receive clearance for both myopia and hyperopia with treatment ranges for myopia of up to -12 diopters and with astigmatism of up to -6 diopters. The approval for hyperopia was granted for up to +6 diopters and with astigmatism of up to +5 diopters, not exceeding a mean spherical equivalent of +6 diopters. Lumenis will be the exclusive sales agent in the U.S. responsible for all sales, marketing and field service efforts.
Medtronic MiniMed (Northridge, California) reported the market introduction of its Paradigm 712 insulin pump, which incorporates a larger reservoir for diabetes patients requiring more insulin to keep their blood sugar levels within a normal range. The new pump, which was recently cleared by the FDA, is small, easy to use and can replace insulin shots for many diabetics. The Paradigm 712 pump holds up to 300 units of insulin and is designed for patients who use more than 50 units of insulin per day. The pump's larger reservoir enhances patient convenience by enabling users to change their insulin reservoirs less often. The system integrates blood sugar information using the Paradigm Link Blood Glucose Monitor, co-developed with BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey). The Paradigm Link monitor automatically transmits a blood sugar value to the Paradigm 712 insulin pump using wireless communication. The pump uses a built-in Bolus Wizard calculator to recommend a proper insulin dosage based upon information entered by the user. The pump also keeps track of insulin previously delivered by the patient and still active in the body.
Medtronic Surgical Navigation Technologies (SNT; Louisville, Colorado), a manufacturer of image- guided surgery systems, debuted its compact intraoperative magnetic resonance imaging (MRI) system, the PoleStar N20, at the recent annual meeting of the Congress of Neurosurgeons. The FDA-cleared PoleStar N20 was developed by Medtronic SNT and its partner, Odin Medical Technologies (Newton, Massachusetts). The mobile MRI unit is designed to seamlessly integrate with the operating room while not requiring the OR to be dedicated to its use. Stephen Papadopoulos, MD, of Barrow Neurological Institute at St. Joseph's Hospital and Medical Center (Phoenix, Arizona), said, "The clinical and financial impact of dedicating one of a hospital's operating theaters solely to the use of an intraoperative MRI can be disastrous, as many of these rooms sit idle when the iMR unit is not in use. With the PoleStar, we avoid these issues, as the unit can be stored when not in use, allowing the room to be utilized for other types of surgery." Barrow is the first U.S. institution to use the PoleStar system.
Medwave (Danvers, Massachusetts) said that researchers from Massachusetts General Hospital (Boston, Massachusetts) presented the results of their study, "Use of a Radial Artery Compression Device for Non-Invasive, Near Continuous Blood Pressure Monitoring in the Emergency Department," during the American College of Emergency Physicians meeting in Boston in October. The study's goal was to compare the Vasotrac Continual Non-Invasive Blood Pressure Monitor to an invasive arterial catheter, considered to be the "gold standard" in regard to accuracy. The conclusion of the study, which will be published in the April 2004 edition of the American Journal of Emergency Medicine, stated that the Vasotrac monitor showed a very strong statistical correlation to an invasive arterial catheter. The Vasotrac also performed at least as well as an oscillometric cuff-based system, according to the study, and offered the advantage of providing data non-invasively and near continuously.
Motion Media Technology (Wilmington, North Carolina) received FDA 510(k) clearance for its integrated healthcare videophone, the Motion Media CareStation 126s. The company said that the CareStation 126s becomes the only videophone offered on the market that has FDA clearance as a Class II medical device. Motion Media calls the CareStation 126s the first stand-alone videophone to provide two-way video, audio and data communications for patient vital signs information, including heart, lung and bowel sounds, blood oxygen saturation, pulse rate, blood pressure, temperature, blood glucose, weight and breath peak flow measurements over standard telephone lines. The system integrates an electronic digital stethoscope that provides for both local and remote auscultation functions and an optional accessory plug-in pulse oximetry sensor unit, along with its ability to simultaneously transport multiple channels of patient data. Typically the CareStation is deployed in a patient's home and another CareStation is installed in a healthcare provider or caregiver's office, and the two systems communicate with each other through internal modems and transmit real-time video, audio and data between them.
Nellcor (Pleasanton, California), a unit of Tyco Healthcare (Exeter, New Hampshire), reported that a study presented at the American Society of Anesthesiologists annual meeting in San Francisco, California, found that centralized pulse oximetry monitoring reduced the median cost of an intensive care unit (ICU) stay by $20,559 for cardiothoracic patients re-admitted to the ICU from the general care floor. The study was led by researchers in the department of anesthesiology at the University of Pennsylvania (Philadelphia, Pennsylvania), who assessed the impact of Nellcor Oxinet Central Station Network on the rate of return to an ICU and costs of hospital care in patients entering the post-cardiothoracic surgical care floor. From June 16, 1999, to Dec. 9, 2002, 1,219 patients entering the post-cardiothoracic surgical general care floor were randomly selected for continuous pulse oximetry monitoring (monitored) or standard intermittent oximetry (unmonitored). There were 589 patients in the monitored group, and 630 in the unmonitored group. The median cost of an ICU stay was $51,111 for the unmonitored group and $31,552 for the monitored group, translating to a savings of $863,478 for all 42 patients who were transferred to the ICU from the monitored group, an average savings of $1,466 per monitored patient.
Nucletron BV (Veenendaal, the Netherlands) reported FDA clearance and worldwide release of the Comfort Catheter System for interstitial high dose rate and pulsed dose rate brachytherapy cancer treatments. The smooth rounded catheter buttons and catheter design enable patients to be treated comfortably on an outpatient basis, to wear normal clothing and to resume typical activities with minimal interference. Channel numbers are marked on the catheter buttons and treatment needle assemblies for quick and accurate connection to the Nucletron microSelectron afterloaders. The catheter's design enables the ability to remove the treatment needle assembly in between patient treatments, reduces the chance of catheter kinking and provides a safer closed-end transport channel for the treatment source.
RITA Medical Systems (Mountain View, California) reported the publication of a study in the Journal of Hepato-Gastroenterology presenting evidence demonstrating that patients who have primary liver cancer and who receive radio frequency ablation (RFA) treatment experience survival rates that compare favorably with surgical results, the current gold standard. Alfredo Guglielmi, MD, lead investigator of the study from the First Department of General Surgery at Verona University Medical School (Verona, Italy), said the study "signals to oncologists, surgeons and radiologists that RFA is an important treatment option for the overwhelming majority of patients who are not candidates for resection surgery." The study reports that after three years survival was 83% in Child-Pugh A cirrhotic patients and 31% in Child-Pugh B patients. Fifty-three patients with a total of 65 lesions were treated with RFA. The RITA system uses radio frequency energy to heat tissue to a high enough temperature to ablate it or cause cell death.
Rubicon Medical (Salt Lake City, Utah) said it has successfully completed the first human cases of its Rubicon Filter in the carotid arteries. Rubicon's carotid studies are being conducted by Dr. Juachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany) and principal investigator for the clinical studies seeking clearance for use of the Rubicon Filter in carotid arteries. The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels than other embolic protection devices. Rubicon said the filter's small profile should considerably decrease trauma to the body and the risk of dislodging particles during passage of the filter through a blockage in a blood vessel.
SpectRx (Norcross, Georgia) said it was granted a patent for its SimpleChoice patch insulin delivery technology. The company said that U.S. patent number 6,629,949 is the first of what will be a series of patents covering the infusion patch and insulin infusion micropump. The first patch product is an insulin pump infusion set, expected to be available later this year. The FDA-cleared patch is designed for use with most insulin pumps on the market today. The reduced depth of microneedle penetration is designed to improve comfort and the overall pump experience. SpectRx currently markets the SimpleChoiceeasy 30-degree insulin pump infusion set and SimpleChoicereservoir disposable insulin cartridge for insulin pumps.
Welch Allyn (Skaneateles Falls, New York) introduced two new electronic thermometers. The new SureTemp Plus 690 and 692 both offer more accurate oral, axillary and rectal temperature readings on patients of all ages and have what the company termed "an easy-to-read LCD display with icons that clearly communicate information to users regardless of language." The SureTemp Plus 690 features a recall button to capture the last temperature reading in an instant. It also has a storage space for 25 probe covers and an optional wall mount that holds an additional 50 probe covers. The 692 model features several security enhancements, such as a programmable location ID indicator on the LCD display, that discourage theft in a more hospital environment. It features LCD display and an ergonomic shape that help make it one of the fastest thermometers available, providing four-second oral, 10-second pediatric axillary and rectal, and 15-second adult axillary measurements.
Viatronix (Stony Brook, New York), a developer of 2-D/3-D visualization software, has received FDA 510(k) clearance for its V3D-Vascular module. The V3D-Vascular module allows radiologists to examine vessels in 2-D and 3-D, fly through, view hard and soft plaque and make precise measurements. The V3D-Vascular module streamlines vascular computed tomography, magnetic resonance and 3-D reconstructed X-ray angiography examinations with a variety of tools to select and visualize entire vascular trees in seconds. The company said the technology in V3D Vascular is able to distinguish and segment poorly enhanced and small vessels throughout the body. Many vessels can be selected with just a single mouse click. V3D-Vascular also contains techniques to visually eliminate calcified plaque from 3-D views, leaving the remaining blood lumen clearly visible.