Arrow International (Reading, Pennsylvania) reported in mid-April that it plans to defer a U.S. clinical trial of its current iteration of the LionHeart Left Ventricular Assist System (LVAS) for a destination therapy indication, saying it prefers to see how the next generation of the device, which has a smaller battery and other system enhancements, fares in the European market, where it was approved via a CE mark last November. The company termed the postponement in the U.S. a "modification of its business strategy," saying it has decided to defer commencement of the LionHeart Phase II clinical trials, required to bring the product to market until it is able to implement product design enhancements currently being tested.
Earlier this year, Arrow initiated its marketing program in Europe and included the training of additional centers to implant the device, supplementing the centers already participating in the clinical trials. The company said its near-term focus in Europe continues to be on obtaining optimal clinical results and evaluating product enhancements currently in development. It noted that these enhancements "should increase the patient population for whom the device is suitable and provide improved quality of life for recipients."
"The LionHeart LVAS is a promising new technology," Chairman and Chief Executive Officer Carl Anderson Jr. said in a statement. "We intend to increase our current sales and marketing efforts for the device in Europe, but we will not proceed with the Phase II clinical trials in the U.S. at this time." He noted that given the significant additional time and costs involved and the current regulatory environment, "we will move forward in the U.S. only when we have assessed comprehensively the impact of our product design enhancements." Anderson added that the company still expects to complete its ongoing Phase I pilot study of the U.S. trials, and is proceeding with the development of its sales and marketing program for the LionHeart in Europe and remains "fully focused on achieving excellent clinical outcomes there."
Arrow had previously reported that it expects revenue generation from initial sales of the LionHeart in Europe to be absorbed by marketing and clinical support costs, which are increasing, and will not contribute to earnings during FY04.
According to Frederick Hirt, the company's chief financial officer, Arrow made the decision on its own to defer the Phase II trial in the U.S., without any pressure from the FDA. "We're going to finish Phase I and then we're going to see how the [new] batteries work in Europe and make a definitive decision on Phase II later," he told The BBI Newsletter. Hirt noted that the new battery is substantially smaller than the first-generation model, weighing about 1-1/2 pounds vs. three to four pounds for its predecessor. "It cuts the weight in half," he said. "It's much smaller [and] you can put it on a belt." He also said the new iteration of the LionHeart will have a new internal controller that is much smaller. "The old configuration was square because of the size of the batteries; the more elliptical shape that we're developing now will not pinch people when they're bending over and so forth, so it will be much more comfortable."
Elsewhere in the product pipeline:
AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the worldwide market launch of the SpeedLyser Thrombolytic catheter, a catheter kit intended for the administration of thrombolytic agents into the peripheral vasculature. The SpeedLyser thrombolytic catheter features slits to help evenly distribute the thrombolytic drug to the blockage. A coaxial system a dual catheter combination of a 3 Fr inner catheter within a 5 Fr outer catheter simplifies access and drug delivery across the entire blocked graft. It also allows a physician to treat a blockage immediately after dissolving the blood clot by providing access for balloon angioplasty through the 5 Fr catheter, an advantage the company said helps to minimize overall treatment time and patient discomfort. The SpeedLyser catheter is offered in lengths of 10 cm, 15 cm and 20 cm.
Anodyne Therapy (Tampa, Florida) reported the publication of a study in the April issue of Geriatric Physical Therapy demonstrating restoration of sensation in the feet of patients with peripheral neuropathy through the use of Anodyne treatments. The patients also obtained significant improvements in ambulation and balance, which led to a 96% reduction in fall rates. Anodyne Therapy is an FDA-cleared light therapy device for increasing circulation and reducing pain.
Applied Imaging (Santa Clara, California) has received 510(k) clearance from the FDA to market its automated applications for Estrogen Receptor (ER) and Progesterone Receptor (PR) analysis in breast cancer patients. Those applications will be used with the company's core platform product, Ariol, which Applied Imaging calls its "flagship product" for high-throughput imaging and analysis. The new applications will use Ariol to "assist in the analysis of tests that are important factors in the selection of certain breast cancer patients to receive hormonal therapies such as Tamoxifen," the company said.
Beckman Coulter (Fullerton, California) said it has introduced two new laboratory automation workstations, the Biomek 3000 and the Biomek NX. Designed for solution-focused life sciences and clinical research markets, the new platforms extend the company's ability to address applications requiring low- to mid-range throughput capabilities. Both systems are available for shipment. The new automated workstations increase sample throughput in low- to mid-range liquid handling applications, improving the accuracy and precision of assays.
Bio-Rad (Hercules, California), a maker of life science products and clinical diagnostics, has received 510(k) clearance from the FDA for its Variant II Turbo Hemoglobin Testing System and Hemoglobin A1c test kit to test for diabetes. The device is used to test blood samples for the marker A1c, a level the American Diabetes Association (Alexandria, Virginia) recommends be checked in those with diabetes two to four times a year, depending on the level of control over the disease that the patient has, said Sarah Paul, diabetes marketing manager for Bio-Rad. Blood glycohemoglobin, or A1c levels, is a key indicator that reflects the average blood sugar levels for the previous one to two months and is used widely in diagnosing diabetes, screening procedures and blood sugar control, the company said. The system works by placing a whole blood sample directly on the instrument, with no sample pre-treatment required, Paul said. The fully automated system then tests for levels of A1c at the rate of about 97 seconds per sample, enabling it to produce very high volume results on a daily basis.
Boston Scientific (Natick, Massachusetts) reported that it has received FDA clearance to market its Contour SE embolic agent for the treatment of uterine fibroids. Contour SE may be used in uterine fibroid embolization, a less-invasive alternative to surgery that generally spares the uterus in women with symptomatic uterine fibroids.
Cardiac Science (Irvine, California) reported the marketing launch of the Powerheart G3-Automatic, a fully automatic portable defibrillator for use in public places and homes. The G3-Automatic is the first patented AED on the market that only requires a rescuer to listen to the device's voice prompts and attach the device to a victim of cardiac arrest. Once attached, the device detects the victim's heart rhythm, analyzes that signal using its RHYTHMx algorithm technology, and, if a life-threatening rhythm is detected, notifies the user to stand clear and delivers an electrical shock capable of restoring normal heart function. The company anticipates shipments to international customers and distributors to begin immediately with sales in the U.S. pending receipt of FDA 510(k) marketing clearance. The device is maintenance-free, weighs only six pounds and comes standard with a five-year replacement warranty.
Cardima (Fremont, California) reported the first clinical use, in an electrophysiology application, of its Inellitemp radiofrequency (RF) energy management device in conjunction with its Revelation series microcatheter to treat atrial fibrillation (AF). Dr. Jaswinder Gill at Guy's and St. Thomas Hospital (London) performed the procedure on a patient suffering from paroxysmal AF using Cardima's Revelation Helix 2.5 STX microcatheter in conjunction with the Inellitemp. The procedure took less than 30 minutes. This ablation process normally takes a minimum of 1.5 hours to 2 hours, the company said.
Cepheid (Sunnyvale, California) reported that its collaborative partner, Infectio Diagnostic (IDI; Saint Foy, Quebec), has received clearance from the FDA to market its new IDI-MRSA test for detecting methicillin-resistant staphylococcus aureus (MRSA). According to IDI, it is the first MRSA test cleared by the FDA for use directly on clinical specimens. The IDI-MRSA test was developed specifically for use on Cepheid's Smart Cycler system, which provides rapid DNA analysis. Through its agreement with IDI, Cepheid said it planned to launch marketing of the IDI-MRSA test in the U.S. clinical market at the American Society of Microbiology meeting in May in New Orleans, Louisiana. Separately, Cepheid reported that it has been issued U.S. patent No. 6,713,297 for "Apparatus for quantitative analysis of a nucleic acid amplification reaction." The patent covers an instrument for amplifying and detecting nucleic acid programmed to use quantitative internal controls or standards to generate a calibration curve and quantify the starting copy number of one or more target DNA sequences in a test sample.
Collagen Matrix (Franklin Lakes, New Jersey) received FDA clearance of three products. Matrix Collagen Sponge is an absorbent, porous collagen matrix intended for the management of moderately to heavily exudating wounds and to control minor bleeding. Matrix Collagen Film is a thin dense membrane that can be used as a primary or secondary dressing in the management of the chronic and acute exudating wounds. Porous Collagen Dental Dressings are porous matrices that are to be used in areas of oral and dental surgeries to assist in tissue healing. These products will provide the wound care community with economical, effective solutions to the treatment of wounds that are difficult to heal, the company said.
Cordis Endovascular (Warren, New Jersey), a division of Cordis (Miami Lakes, Florida), a Johnson & Johnson company, reported that it has received FDA clearance to market the Optease Vena Cava Filter. Design of the Optease Filter provides an option for it to be percutaneously retrieved or to be permanently placed in a patient's inferior vena cava vessel. The Optease filter, based on the design of Cordis' Trapease Permanent Vena Cava Filter, incorporates a caudal hook for percutaneous retrieval from the femoral vein, and an amended barb design combining migration resistance, while allowing for a controlled retrieval. The Optease's self-centering design also optimizes clot capture efficiency and centers the retrieval hook for easy, consistent filter retrieval. Using a 6 Fr delivery system and featuring the lowest profile on the market, the Optease provides patients with the least invasive vena cava filter available, the company said.
Cordis (Miami Lakes, Florida) reported it has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Cypher sirolimus-eluting coronary stent in Japan. Cypher stent distribution in Japan is expected to begin at mid-year, coincident with government approval of reimbursement. The Cypher stent is Japan's first approved drug-device combination to significantly reduce the incidence of restenosis of a treated coronary artery. The Cypher stent has been shown to reduce restenosis by 90% compared with a conventional bare-metal stent.
Cygnus (Redwood City, California) reported that the FDA approved its premarket approval application supplement for the expansion of the labeling to include a description of pretreatment products and a method to minimize the effects of skin irritation without affecting the accuracy of G2 Biographer glucose measurements. Clinical data submitted by Cygnus showed a significant reduction in irritation with pre-treatment with Kenalog aerosol spray from Westwood-Squibb Pharmaceuticals (Buffalo, New York) and Cortizone-10 Quick Shot spray from Pfizer (New York).
Digene (Gaithersburg, Maryland) said that a study published in the April issue of Obstetrics & Gynecology finds that screening women 30 years of age or older with both a Pap and human papillomavirus (HPV) test reduces cervical cancer incidence by up to 93% and results in a 30% cost savings compared to the traditional annual Pap exam. The research concluded that compared to the traditional annual Pap used alone, routine screening every two to three years that includes testing for HPV which causes virtually all cases of cervical cancer increases protection against the malignancy as well as reduces the average, per-woman lifetime cost associated with screening. Digene's DNAwithPap Test is the only test for high-risk types of HPV approved by the FDA.
Entelos (Foster City, California) reported the development of its Metabolism PhysioLab technology for studying human obesity and diabetes. The Metabolism PhysioLab platform details the pathophysiology of complex and heterogenic human metabolic diseases and is being used to differentiate animal response from human response. The platform can now examine progression and regression of Type 2 diabetes pathophysiologies, substrate utilization in the liver, and a variety of additional therapies.
Epoch Biosciences (Bothell, Washington) reported that a new panel of assays targeting single nucleotide polymorphisms (SNPs) identified by researchers at the National Cancer Institute (NCI; Bethesda, Maryland) as having a high association with certain cancer patient populations are available and being sold directly by Epoch. The validated real-time PCR assays are based on the company's MGB Eclipse Probe Systems and were developed in cooperation with members of NCI's Cancer Genome Anatomy Project using Epoch's MGB Eclipse By Design service. MGB Eclipse By Design features high genotyping call accuracy and the ability to detect problematic SNPs, while eliminating the lengthy and time-consuming process of assay development.
FEI (Hillsboro, Oregon) said that scientists at the company's nanotechnology center have broken the one Angstrom image resolution barrier with a 200 kV transmission electron microscope. The company said that this is the first time images can be viewed directly with a resolution of less than one Angstrom one-10th of a nanometer in size and a key dimension for atomic level research using commercially available technologies. The sub-Angstrom resolution was achieved using FEI's Tecnai F20 ST transmission electron microscope, using technologies which improve image resolution with advanced electron optics capabilities developed by FEI and by its partner, Corrected Electron Optical Systems (Heidelberg, Germany).
FlowMedica (Fremont, California) reported the initiation of a post-market clinical study of its FlowMedica Benephit Infusion System, an infusion catheter system for delivering therapeutic agents directly to the kidneys via the renal arteries. Participating physicians are evaluating the system's ability to deliver a vasodilator drug selectively to the kidneys to prevent certain changes in kidney physiology associated with radiocontrast nephropathy. The system delivers therapeutic agents directly to the renal arteries through a dedicated bifurcated infusion catheter, allowing simultaneous coronary procedures and therapeutic agent infusion through a single access site in the femoral artery via an introducer sheath.
HDC (Milpitas, California) reported FDA approval to market the Neuro-Trace III. The neuromuscular transmission monitor is capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using self-calibrating accelerometry for measuring the muscle contraction following a stimulation of the respective motor neuron; as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring; and as a nerve-locating/nerve-mapping device, in which case an external probe is used to locate nerves that are less than 6 cm (with the exception of the sciatic nerve). The company said the Neuro-Trace III is the only pain management development of its kind to employ features such as nerve mapping, regional block nerve locator and tri-axial accelerometer in a single device.
Hill-Rom (Batesville, Indiana) reported launch of the VersaCare Bed System, a full-featured hospital bed designed to help deliver effective wound therapy and improved patient and caregiver safety in the medium- to high-acuity medical-surgical environment. Features of the VersaCare Bed System include low height, low chair positioning, turn assist and the IntelliDrive power-assist transport system, an optional feature that allows a caregiver to transport patients without strenuous pushing. The Flexafoot mechanism helps keep patients from sliding down in bed, and the Active Intelligence Response treatment mattress integrated into the bed uses zones of continuous low pressure to help reduce the risk of skin ulcers.
Hologic (Bedford, Massachusetts), a provider of women's diagnostic imaging systems and digital radiology systems, and R2 Technology (Sunnyvale, California), a pioneer in computer-aided detection (CAD) technology, said that R2 has received FDA approval for the use of its ImageChecker CAD technology customized for Hologic's Selenia full-field digital mammography system. The Hologic Selenia produces digital X-ray images captured without film and is designed to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. Under a five-year agreement, Hologic has exclusive worldwide distribution rights to sell the R2 customized product in combination with its Selenia system. Hologic also has distribution rights for R2 CAD products for use with conventional film-based mammography systems that are able to be upgraded to digital mammography systems.
iCAD (Nashua, New Hampshire) reported that the U.S. Patent and Trademark Office has issued the company two patents for its Fulcrum mammography film digitizer and technology. Patent No. 6,687,0251 covers an approach that allows fast and accurate edge-to-edge digitization of mammograms and other X-ray films. Patent No. 6,697,173 covers a novel approach to calibration of the baseline white reference that is specific to digitizers used for both film and paper scanning.
Inamed Health (Santa Barbara, California) reported FDA approval and market introduction of a product line extension to the BioEnterics Lap-Band System. The Lap-Band VG System is an adjustable, inflatable silicone band that is laparoscopically placed around the upper portion of the stomach, creating a small gastric pouch that limits the amount of food the stomach will hold at any time. The Lap-Band VG system is designed to meet the needs of a more diversified and broader patient population, including patients with a larger internal anatomy. The company said the Lap-Band VG system requires less fat dissection, has easier band placement and offers new technology to decrease the risk of crease-fold failure seen in competitor products.
Invacare (Elyria, Ohio) received FDA clearance to market the Polaris EX Continuous Positive Airway Pressure (CPAP) with SoftX Technology and the Polaris EX Heated Humidifier. The Polaris EX CPAP features SoftX, an exhalation unloading feature designed to allow CPAP patients those who suffer from obstructive sleep apnea to breathe more easily upon exhalation. SoftX technology is designed to make breathing easier and more comfortable. The Polaris EX Heated Humidifier provides humidification during CPAP therapy, eliminating the dry nose and throat discomfort and reducing nasal swelling. It is specifically designed to attach to the front of the Polaris EX CPAP and is not compatible with any other CPAP flow generator.
Karl Storz Endoscopy-America (Culver City, California) said it has incorporated new software within its Image 1 camera heads that provides significant advantages over previous software configurations. The enhanced software gives surgeons complete control of light source functionality directly from the camera head within the sterile field. The upgrade also increases scene illumination to create a brighter image when using smaller endoscopes. The enhancement provides camera and light source control using reprogrammable buttons on the camera head. The Image 1 software improvement also increases the average picture level set point to create a brighter image overall, which helps to increase illumination of areas that are recessed or when the field of view is saturated by fluids. Karl Storz Endoscopy-America also reported the launch of its Medi Pack Mobile Imaging Station as an integrated endoscopic video solution for use in emergency rooms, physicians' offices, ICUs and other clinical environments. The compact Medi Pack offers a comprehensive range of capabilities, including digital image storage, and voice recording. The Medi Pack Mobile Imaging Station includes a camera control unit, high-performance cold light source, documentation module, 12" high-resolution color LCD monitor, a sealed membrane touchpad for entering patient data, and universally compatible camera head. The system is fully transportable and can be operated on a 120-240 VAC power supply and includes an AC power converter for use in remote locations.
Kensey Nash (Exton, Pennsylvania) said enrollment has been completed in the randomized trial of its TriActiv Balloon Protected Flush Extraction System. The PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) trial randomized TriActiv against other approved embolic protection systems or the standard of care, measuring major adverse cardiac event (MACE) rates in the treatment of saphenous vein graft disease. The PRIDE study enrolled 894 patients at 68 sites in the U.S. and 10 sites in Europe. The TriActiv System is designed to prevent debris, liberated during a stent procedure, from embolizing and causing a MACE. Data from the trial will be used to support FDA approval of a 510(k) application, which the company said it expects to submit by June.
Kyphon (Sunnyvale, California) said it received a 510(k) clearance from the FDA to market KyphX HV-R Bone Cement for the fixation of osteoporosis-related pathological fractures of the vertebral body during kyphoplasty, noting that thousands of patients previously have had the procedure performed off-label, netting the company millions in revenue despite the handicap of having no official bone cement application approval. The finding of "substantial equivalence" for the product was based on clinical data supporting certain short- and long-term outcomes of kyphoplasty, and the new approval could expand the market for the procedure by enabling the company to market kyphoplasty directly to physicians. During the minimally invasive balloon kyphoplasty procedure, which is used to treat deformities brought on by vertebral body compression fractures that occur in osteoporosis, two KyphX Xpander inflatable bone tamp balloons are inserted into the bone via small incisions. After the balloon is expanded, bone cement is filled into the void left by the balloon, creating a permanent stabilization filler.
MeDevice (Cheyenne Hills, Texas) is offering an over-the-counter solution for carpal tunnel syndrome (CTS) pain that it says combines low cost with proven pain relief and translates to no lost workdays. The Ctrac looks somewhat like a large wristband made of metal with a small balloon pump attachment. An FDA Class 1/exempt pneumatic traction device, the Ctrac is placed on the wrist over the median nerve and is operated by the wearer. It is recommended for use three times a day in five-minute periods for four to six weeks in the initial treatment. After that it is used as needed, usually about once a month as a maintenance treatment.
Medical Services International (Edmonton, Alberta) reported that it has completed a second set of testing of its hepatitis B rapid test kit in the People's Republic of China. The results of the latest testing show that the VScan Hepatitis B test kit was 99.8% accurate. The company said it would immediately begin the process of filing the documents for regulatory approval of the hepatitis B test kit in China. The rapid test kit is a single-use test for the screening of HIV 1 & 2 and subgroup O, hepatitis B & C, tuberculosis and West Nile virus.
Medtronic (Minneapolis, Minnesota) reported FDA approval and market introduction of a second version of its pacing lead, CapSureFix Novus. The new CapSureFix Novus Model 4076 lead is a polyurethane-insulated version of the CapSureFix Novus Model 5076, which has a silicone outer insulation. Both are slender, active-fixation leads designed to be anchored in specific locations of the heart wall for the treatment of bradycardia, tachycardia and atrial fibrillation. The Model 4076 is slightly thinner than the 5076 (5.7 Fr vs. 6.1 Fr). Both use silicone to insulate inner conduction materials, both elute a steroid to reduce pacing thresholds, and both offer 10 mm tip-to-ring spacing. The newer model incorporates titanium nitride-coated electrodes. Separately, Medtronic reported that it has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Sprinter Semi-Compliant Rapid Exchange Balloon Dilatation Catheter for use in coronary angioplasty procedures. The Sprinter balloon is immediately available in Japan in lengths of 6 mm, 12 mm, 15 mm, 20 mm, 25 mm and 30 mm and diameters of 1.5 mm to 4 mm. The Sprinter balloon provides the latest in balloon technology and is equipped to address the most difficult lesions in coronary angioplasty procedures, the company said.
MIV Therapeutics (MIVT; Vancouver, British Columbia) reported that its Hydroxyapatite (Hap) ultra-thin coating technology has passed the Systemic Injection Test (ISO), which the company said is an important milestone on the path to commercialization. The company is developing a line of next generation biocompatible coatings for stents and drug delivery systems for the treatment of cardiovascular disease. MIVT's Vice President of Operations, Arc Rajtar, said, "The HAp coating technology is successfully progressing through a comprehensive range of animal and mechanical trials required for CE mark and FDA approvals. To date [our] proprietary HAp coating passed thrombogenicity, cytotoxicity and demanding fatigue life testing which could be considered a benchmark for durability testing of coated stents."
Nellcor (Pleasanton, California) said it is launching the Nellcor OxiMax NPB-75 Handheld Capnograph/Pulse Oximeter. The product delivers accurate SpO2 and end-tidal CO2 measurements within a convenient, portable, hand-held unit. The NPB-75 monitor delivers accurate pulse oximetry readings, even with the challenging conditions of patient motion or low perfusion. Microstream CO2 technology, from Oridion (Jerusalem, Israel) is featured in the NPB-75 monitor and ensures effective capnography monitoring for both mechanically ventilated and non-intubated patients, and is indicated for use with neonates through adults. The extensive selection of Microstream breath-sampling accessories ensures accurate end-tidal CO2 measurements and crisp waveforms, providing a clear picture of patient respiratory status, even in high humidity environments.
Novo Nordisk Pharmaceuticals (Bagsvaerd, Denmark) reported the introduction of its ReliOn/Novolin InnoLet Human Insulin (rDNA origin) prefilled insulin doser to Wal-Mart's (Bentonville, Arkansas) ReliOn brand of diabetes healthcare products. The insulin doser is designed as an alternative to the vial and syringe method of insulin delivery used by many people with diabetes, at a price comparable to branded vial insulin. It has an easy-to-read "kitchen timer" design to help set the correct dose. Under the ReliOn brand, Novolin InnoLet will be offered in the most commonly prescribed human insulin formulations. Each ReliOn/Novolin InnoLet contains 300 units insulin with maximum of 50 units for each injection.
ONUX Medical (Hampton, New Hampshire) has expanded its line of Procedure Specific Implant Cartridges to support the Salute Fixation System for open surgical procedures. The Short Cannula Salute is now available in 30 Q size for specific open procedures that require additional fixation. Varying the capacity of the Implant Cartridge has the benefit of providing the required fixation count in a single cartridge simplifying the delivery of fixation while controlling cost to the end user.
OraSure Technologies (Bethlehem, Pennsylvania) reported approval for what many are calling a breakthrough application of its rapid HIV diagnostic test kit, the OraQuick Rapid HIV-1/2 Antibody Test. The new application uses oral fluid a distinctly more attractive alternative to the drawing of blood for fast results and becomes the first such test for HIV approved by the FDA. The significance of this is that the test is likely to have much broader use and provide results to more people even more quickly than ever, according to the FDA and other government and health officials. The original version of this rapid test, the OraQuick Rapid HIV-1/2 Antibody Test, was FDA-cleared in November 2002 for detection of antibody to HIV-1 in blood, essentially a fingerstick test. On March 19, the test was FDA-cleared for the detection of HIV-2 also in blood. The person being tested for HIV-1 uses an exposed absorbent pad and places the pad above the teeth and against the outer gum. The person then swabs around the outer gums, both upper and lower. The tester then takes the device and inserts it into a vial containing a solution. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution, by displaying two reddish-purple lines in a small window on the device.
PhotoThera (San Diego, California) reported that it has received FDA approval to market its Acculaser Pro therapeutic laser for use in the non-surgical treatment of a painful overuse tendonitis injury of the knee common to runners and athletes called iliotibial band syndrome. The non-invasive PhotoThera laser is easy to apply in the physician's office by a trained therapist, the company said.
PLC Systems (Franklin, Massachusetts) reported that a cardiac surgical team from Good Samaritan Hospital (Cincinnati, Ohio) has completed the first carbon dioxide (CO2) transmyocardial revascularization (TMR) procedure with robotic assistance. J. Michael Smith, MD, a cardiac surgeon and director of robotic surgery at Good Samaritan, performed the operation using the CO2 Heart Laser from PLC to create new blood-flow channels in the heart of a 66-year-old angina patient. The patient was discharged after two days. With visualization and several small incisions, PLC Systems said a surgeon can perform TMR with its CO2 Heart Laser, which is distributed by Edwards Lifesciences (Irvine, California), less invasively than through an open chest or thoracotomy.
Quinton Cardiology Systems (Bothell, Washington) reported that it has started shipping networked versions of its Q-Tel RMS. Q-Tel is a comprehensive, dedicated cardiac rehabilitation management system allowing clinicians and administrators to monitor patients' ECG signals in real time, quickly enter patient data, customize treatment protocols, track risk factors and report patient outcomes. The networked product enables the monitoring of up to 36 patients off the same database and workstations are now available for full remote access to the database.
Spire reported that Spire Biomedical (Bedford, Massachusetts), its wholly owned subsidiary, introduced its new Decathlon catheter and exhibited its other catheter products at the Society of Interventional Radiology meeting in Phoenix, Arizona. The FDA-cleared Decathlon incorporates advanced Carbothane material, high flow at low pressures, and a superior split distal tip configuration, all of which enhance catheter function and durability, the company said.
Sysmex America (Mundelein, Illinois) reported that the FDA has cleared the Body Fluid application on its XE-2100 Series Automated Hematology Analyzers. Automated body fluid analysis can now be performed on cerebrospinal fluid, serous and synovial fluids using the XE-Series Automated Hematology Analyzers. The white blood cell (WBC) count is obtained from the Differential Channel, which uses Sysmex's Fluorescent Flow Cytometry technology to separate WBCs into distinct cell clusters. The red blood cell count is obtained using DC detection with hydrodynamic focusing. No specimen preparation is needed before sample analysis.
Therics (Princeton, New Jersey), a subsidiary of Tredegar, reported that it has received FDA clearance to market a resorbable beta-tricalcium phosphate bone void filler device used to treat osseous defects of the skeletal system. The TheriLink, TheriWedge and TheriMatrix extensions covered by the clearance complete a new line of bone graft products that also includes TheriFil and TheriLok. These implants cover a spectrum of clinical applications in the orthopedic and neurosurgical markets. Each is manufactured using Therics' TheriForm microfabrication process. The products feature a biocompatible, beta-tricalcium phosphate design that creates a resorbable interlocking network within the defect site to promote healing.
Third Wave Technologies (Madison, Wisconsin) reported the launch of its Invader Cystic Fibrosis (CF) genotyping analyte-specific reagents (ASRs). The Invader CF genotyping ASRs enables CLIA-certified high-complexity laboratories to develop individual assays for a total of 44 CF genetic mutations. Third Wave also reported that it has signed a supply agreement for the Invader CF genotyping reagents with Kaiser Permanente (Oakland, California). Kaiser-affiliated hospitals, medical centers and clinics incorporated the new Invader product into their service offerings beginning last month.
Turbo Wheelchair (Beaufort, South Carolina) reported a new line of durable, foldable, solid-seat wheelchairs. The Merlexi Craft manual wheelchair, designed with a grant from the National Institutes of Health (Bethesda, Maryland), employs a high-strength plastic construction that makes it more lightweight and durable than conventional steel-frame chairs. The Merlexi Craft chairs have ergonomically molded foldable seats, removable, adjustable armrests and footrests as well as a series of backrest options. The chairs are available in an assortment of colors, and the high-strength plastic construction is weatherproof and easy to maintain, the company said.
Vascular Solutions (Minneapolis, Minnesota) reported receiving CE mark approval for its Vari-Lase laser console and procedure kit used in the endovenous laser treatment of varicose veins. Receipt of the CE mark will allow commercialization of the Vari-Lase procedure to begin through the company's direct sales force in Germany and through the company's independent distributors in other European countries. The Vari-Lase line consists of a laser console and a custom-designed procedural kit used in endovenous laser therapy for reflux of the great saphenous vein. Vascular Solutions also reported that it has received FDA clearance for its D-Stat Dry 3x3 hemostatic bandage, a new version of the company's original D-Stat Dry product. The 3x3 version is a larger, three-inch-square pad that can be applied topically to active bleeding sites to assist in the hemostasis process. Potential applications for the D-Stat Dry 3x3 product include opportunities in trauma and emergency medical procedures.
Viatronix (Stony Brook, New York) has received FDA approval for use of its V3D-Colon system as a screening tool for detecting colon cancer, the first ever for a virtual colonoscopy exam, according to the company. Results of a virtual colonoscopy study published in the December 2003 New England Journal of Medicine (NEJM) and American Journal of Roentgenology citing results more reliable and accurate than other virtual colonoscopy systems led to the FDA approval for the screening indication. Cathy Callegari, a spokesperson for Viatronix, said that prior to this approval all the companies involved in the virtual colonoscopy space had approvals only for display and visualization purposes. "So now, [this approval is] for the purpose of patient screening," she said. Whether the virtual colonoscopy will supplant the traditional optical approach remains to be seen, but the screening clearance is clearly an important first step to more widespread use of the newer approach. "Up until now, [people] have always used the argument that this wasn't FDA-approved," said Callegari, "so that argument's now moot."
Vision-Sciences (Natick, Massachusetts) reported the introduction to the U.S. market of the ENT-1000, an EndoSheath system that includes a small (2.4 mm) diameter Ear-Nose-Throat Endoscope and a Slide-On EndoSheath. The ENT-1000 is designed to enhance the range and quality of ENT procedures. The slim insertion tube diameter is designed for ease of scope passage through small openings, while providing maximum patient comfort. At 300 mm, the overall working length enables full access to the laryngeal region, and the articulation provides maneuverability to enable ideal viewing. The ENT-1000 endoscope and the ENT Slide-On EndoSheath system will be distributed in the U.S. and Canada through Medtronic Xomed (Jacksonville, Florida).
Zassi Medical Evolutions (Fernandina Beach, Florida) reported that its Zassi Bowel Management System (BMS) has shown reductions in hospital-acquired infections. The Zassi BMS is a catheter-based system designed to reliably divert, collect and contain potentially harmful and contaminated fecal waste from bedridden patients. A study presented in February showed that the Zassi BMS helped reduce both urinary tract infections and skin and soft tissue infections by more than 50%. Bloodstream infections also showed a decline. The authors were reporting on their initial experience with about 140 BMS catheters since April 2003. They showed that the Zassi BMS was effective for the containment of stool, that they had no safety issues, and that the staff was satisfied with the system.