Accuray (Sunnyvale, California) reported the release of Synchrony, a new enhancement to its CyberKnife stereotactic radiosurgery system that it claims is the first technology in the world capable of delivering dynamic radiosurgery to targets that move with respiration, such as lung, liver, kidney and pancreatic tumors. The company said the Synchrony respiratory tracking system has been a much-anticipated enhancement that enables real-time dynamic tracking and delivery of a highly precise dose of radiation to targets that move with respiration.
Henrik Bacho, marketing manager for the Synchrony, said the new system is a major upgrade for the CyberKnife. "That allows the system to track tumors that move with respiration in real-time," he told The BBI Newsletter. He added that such a system is ideal for treating tumors on the lungs "and really anywhere in the abdominal/thoracic area where the diaphragm is causing movement of the internal body organs." Some other areas that he said the system could be used for include the kidneys, liver and pancreas.
The CyberKnife is a non-invasive, 100% frameless image-guided radiosurgery system that ablates tumors and other lesions anywhere in the body without open surgery. The CyberKnife System treats in single or staged (typically two to five) sessions, and monitors internal reference points in the anatomy (skeletal landmarks or small implanted markers) to correct for patient movement in real time during actual treatment. It delivers multiple beams of precisely directed radiation that converge upon the tumor while minimizing injury to surrounding healthy tissue. With this new upgrade, the company said it is the only system in the world that integrates real-time image guidance and robotic delivery of radiation to deliver proven sub-millimeter "total clinical accuracy."
"Launching the Synchrony System represents a major advance in the technology of radiation treatments," said Euan Thomson, PhD, president and chief executive officer of Accuray. "The human body is a dynamic, moving organism, but traditional radiation treatment devices have a static approach to treatment delivery that is unable to compensate for the body's natural motion. The Synchrony System maximizes the benefits of the CyberKnife's robotic, image-guided capability to track tumors as they move, and now opens a new cancer market to radiosurgery."
Bacho described how the Synchrony works. He said a fiber optic beacon system attached to a patient's chest area monitors the respiratory motion. "It does this with a fiber optic camera that reads these beacons that shoot out as visible light." He said that the camera takes images 30 times a second, providing the real-time tracking. That respiratory motion is then correlated to the motion of the tumor, which is imaged every time a treatment is performed.
Elsewhere in the product pipeline:
Alcon (Fort Worth, Texas) said the FDA has approved an expansion of the treatment range for its customized wavefront-guided LASIK procedure, CustomCornea. Performed with the LADARVision System, CustomCornea is now approved for treatment of nearsightedness (myopia) up to -8.0 diopters (up from -7.0) and astigmatism up to -4.0 diopters (up from -0.5). Eye surgeons can now use the LADARVision System to treat more than 90% of all myopic LASIK patients with the customized procedure, Alcon said. With CustomCornea, physicians are able to measure and treat visual abnormalities that have never been detected before, the company said, adding that the treatment can provide patients with better quality of vision after surgery than they had with contacts or glasses.
Allergan (Irvine, California) said the FDA has approved Botox (botulinum toxin type A) for the treatment of severe primary axillary hyperhidrosis (severe underarm sweating) that is inadequately managed with topical agents. The approval was based on the results of two Phase III clinical studies, one in the U.S. and one in Europe. In the U.S. study, significantly more patients receiving Botox vs. placebo achieved at least a two-grade improvement from baseline on the four-point Hyperhidrosis Disease Severity Scale, which assesses the severity of hyperhidrosis and how it affects a patient's daily activities. Quantity of underarm sweat production also was significantly decreased. One to two Botox treatments were sufficient for most patients who responded in the 52-week pivotal study. Botox is a sterile, purified protein that works by blocking the nerve impulses that, in the case of hyperhidrosis, cause sweat glands to be stimulated.
AntiCancer (San Diego, California) reported receiving its sixth patent from the U.S. patent office covering the use of fluorescent proteins for imaging of cancer, gene expression, stem cells and other processes in animals and humans. The technology uses fluorescent proteins from jellyfish, corals and other bioluminescent animals genetically incorporated into cancer cells, stem cells and other cell types. The fluorescent proteins also can be linked to genes-of-interest to image gene expression. Founded in 1984, AntiCancer also develops diagnostics for diseases including cancer, as well as genetic and stem-cell approaches to cancer and hair follicle therapy.
Biosite (San Diego, California) has devised a new point-of-care panel that will be used to aid in the diagnosis of patients who present at emergency departments with shortness of breath, with the company saying that more than 10 million people present at EDs each year with a combination of chest pain and shortness of breath, or dyspnea, called the Triage Profiler Shortness of Breath panel, the new diagnostic symptom panel is intended to "accelerate and improve emergency department evaluation of shortness of breath," the company said.
Boston Scientific (Natick, Massachusetts) reported the worldwide launch of its Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch for vascular or cardiac patch grafting. The company said the Hemashield Platinum Finesse patch has 50% improved porosity over the existing Hemashield Finesse Patch and provides excellent hemostasis, or a reduced amount of bleeding after closing the incision. The patch is tapered and pre-trimmed for greater efficiency and it conforms to the host vessel for improved handling. It features a thin profile with a high degree of suture strength for a smooth, secure closure with sutures that will remain intact, even at the edge of the patch, according to Boston Scientific
What if a patient is too sick to undergo the invasive surgical procedure needed to install a ventricular assist device (VAD)? That is a problem being addressed by CardiacAssist (Pittsburgh, Pennsylvania) with its TandemHeart PTVA (percutaneous transseptal ventricular assist) System, a left ventricle support device that avoids the surgical procedure of the standard VAD and provides support for a broad range of applications in acute heart failure. And it may even expand the opportunities for traditional VADs, according to Michael Garippa, president and chief executive officer. The TandemHeart PTVA is actually a combination of three systems: a pump somewhat smaller than a hockey puck, a cannula set threaded up to the heart via the femoral vein, and a control console that drives and lubricates the pump while providing system monitoring and alarms. Once the cannula is threaded to the heart, it draws the blood out of the left atrium, goes through the pump and gets returned via another cannula in the femoral artery. Essentially it works as an atrial-to-femoral bypass system. The pump itself, constructed primarily of metal and plastic, is external, held on the thigh in a holster. It produces 4 liters/minute of blood flow and simultaneously delivers an anticoagulant drug (typically heparin) to minimize the risk of thrombus formation.
Cardiac Science (Irvine, California) has begun shipping its Powerheart AED (automated external defibrillator) G3-Pro and Powerheart AED G3-Automatic to international customers and distributors. The company also reported that the PowerheartG3-Pro AED has been cleared for sale throughout Australia by the Australian Therapeutic Goods Administration. Sales of the new models in the U.S. will commence upon clearance by the FDA, which is pending. Features include manual override capability, a multi-color electrocardiogram (ECG) display, continuous ECG monitoring, multiple rescue data storage, comprehensive AED and cardiopulmonary resuscitation voice prompts, infrared data transfer and an optional rechargeable battery.
Confirma (Kirkland, Washington) reported that it is offering its new CADstream 3.1 computer-aided detection device with an added analysis tool called the SureLoc, designed to allow for more convenient – and shorter – magnetic resonance imaging (MRI)-guided interventional procedures, such as biopsy. Confirma received 510(k) clearance from the FDA for CADstream 3.1 on July 7. "SureLoc helps physicians perform breast biopsy and localization of lesions seen by MR in a very efficient way and makes it a procedure that we can now much more readily do in a busy practice environment to help these women," Justin Smith, MD, chief medical officer and a founder of Confirma, said. The company said SureLoc is the first such tool to be offered with a CAD device.
Coronado Industries (Fountain Hills, Arizona), a maker of pneumatic devices for treating glaucoma, said it received approval for its application for 2A CE mark certification covering its glaucoma treatment device. The 2A certification covers both the automated vacuum controller and disposable ring used to administer Coronado's PNT process, allowing European marketing. John Sharkey, PhD, director of operations, said that the company "can now move forward with implementing our strategy toward obtaining registrations within other major markets such as the U.S." Coronado, through its Ophthalmic International subsidiary, has developed the PNT procedure as an alternative for treatment of open angle and pigmentary glaucoma.
CryoCor (San Diego, California) reported that it has received conditional approval to begin a U.S. pivotal clinical study to treat paroxysmal atrial fibrillation under an investigational device exemption granted by the FDA. The purpose of the pivotal study is to evaluate the safety and efficacy of the CryoCor Cardiac Cryoablation System, a minimally invasive medical device that employs cryogenic energy and a single-use cardiac catheter. Investigators at up to 25 clinical sites in the U.S. will use CryoCor's system – intended to selectively freeze cardiac tissue to block conduction of the abnormal electrical signals causing atrial fibrillation and return the heart to its normal rhythm.
Dade Behring (Deerfield, Illinois) said testing with its PFA-100 analyzer can be used as an aid to assess whether aspirin is inhibiting platelet function in patients with cardiovascular disease. When these patients' platelets are not sufficiently inhibited, risk of thrombosis increases. The PFA-100 test is indicated for the detection of aspirin-induced platelet dysfunction, with a sensitivity of 95% in normal individuals following ingestion of a single 325 mg aspirin tablet. If PFA-100 test results are abnormal after aspirin intake, this may show an inhibitory effect on the patient's platelets.
DePuy Spine (Raynham, Massachusetts) reported that orthopedic surgeons at William Beaumont Hospital (Royal Oak, Michigan) have performed the first spinal fusion surgery using rhGDF-5, a new, genetically engineered protein, as part of a clinical trial at six U.S. sites. The protein is placed on a specially designed sponge and inserted between the vertebrae to encourage bone growth and stability at the fusion site. Doctors believe the use of rhGDF-5 may eliminate the need to surgically harvest pelvic bone for the fusion surgery, a procedure that can result in post-operative pain and other complications. The trial's goal is to determine the safety and effectiveness of rhGDF-5 in patients undergoing spinal fusion surgery as compared to the traditional method. DePuy is sponsoring the investigation of this protein and Healos, its delivery system. RhGDF-5 was discovered by Biopharm GmbH, which partnered with DePuy Spine to create the combined product now under evaluation.
Epix Medical (Cambridge, Massachusetts) reported initiation of its post-new drug application clinical program with the first injection in a multi-center trial of MS-325 for high-resolution vessel imaging. MS-325 is a magnetic resonance imaging (MRI) blood pool contrast agent designed for vascular applications. The study goal is to improve high-resolution imaging with MS-325 as the first step in the characterization of vascular wall structures and vulnerable plaque. A new drug application for MS-325 use in MR vascular imaging was accepted for filing by the FDA in February. A separate filing was accepted by the European Agency for the Evaluation of Medicinal Products (EMEA) in June. The product has been co-developed by Epix and Schering AG (Berlin; Germany), with Epix saying MS-325 may be an alternative to invasive X-ray angiography for diagnostic vascular imaging.
Exactech (Gainesville, Florida) reported the introduction of the Optetrak Hi-Flexknee, thereby expanding its Optetrak knee system. The new design is intended to provide improved flexibility following knee replacement surgery, offering 145 degrees of flexion compared with Optetrak's normal 125 degrees. David Petty, executive vice president for sales and marketing, said, "In Asian and Middle Eastern cultures people commonly bend their knees more than in Western cultures – for example, to pray or when eating. The Hi-Flex Optetrak gives surgeons the ability to provide patients higher flexion to meet these important daily living requirements. In addition, many Americans . . . desire a greater range of motion for their active lifestyles." Exactech develops orthopedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians.
Enhanced Vision (Huntington Beach, California) reported its new LCD panel platform, which works with the company's Max and Flipper digital magnification products. MaxPanel and FlipperPanel are lightweight, compact and portable with a slim LCD Panel and are powered by a proprietary, rechargeable battery platform. MaxPanel extends the flexibility of the Max digital magnifier, enabling users to view full color images on a portable screen. FlipperPanel integrates Flipper, a 225-degree rotating full-color, auto-focus camera with the new LCD platform and projects images, near or far, on a slim, portable screen. Product magnification ranges from 2x to 22x depending on configuration and can be adjusted with the turn of a knob. Users can select 7" or 10" screens. A soft carrying case and accessory items are included.
GE Healthcare (Waukesha, Wisconsin) has reported the commercial introduction of the LightSpeed VCT, or volume CT (computed tomography), which one product manager called "the beginning of the volume CT generation of CT scanners." The new device, which will be available later this year, was introduced in late June at Stanford University's (Palo Alto, California) 6th annual International Symposium on Multidetector-Row CT in San Francisco, California. "What we mean by [VCT] and what has actually been defined . . . in the scientific literature, as far as volume and what volume CT means, is it is the combination of wide-volume coverage at thin slice, so the ability to do both simultaneously," said Scott Schubert, global product manager for the LightSpeed VCT. He added, "That's always been the strength of CT, to be able to acquire thin slices, but now with the LightSpeed VCT system, we're able to acquire four times the volume coverage on the 64 channels compared to the coverage that was available on 16-slice scanners."
Gen-Probe (San Diego, California) and Chiron (Emeryville, California) reported the initiation of the pivotal clinical trial of the companies' Procleix West Nile virus (WNV) blood-screening assay. The pivotal clinical trial, which is being conducted at five U.S. blood centers, will evaluate the Procleix WNV Assay's sensitivity, specificity and reproducibility on the semi-automated instrumentation platform called eSAS. Blood will be tested in pools of 16 and individually in the trial, which is expected to last approximately four months. Gen-Probe and Chiron said they expect to begin IND testing of the Procleix WNV Assay this month on the fully automated, high-throughput TIGRIS amplified nucleic acid testing instrument. The TIGRIS system is expected to increase the efficiency of testing individual blood donations. The companies also said that since the start of this year's mosquito season in May, ongoing screening of the U.S. blood supply with the Procleix WNV Assay in investigational use has detected 20 WNV-infected donations to date, preventing transfusion of virally contaminated blood into as many as 60 blood recipients.
Immunicon (Huntingon Valley, Pennsylvania) said that it was informed by Veridex (Raritan, New Jersey), a Johnson & Johnson company, that the CellSearch Epithelial Cell Control Kit received FDA clearance for in vitro diagnostic use. The CellSearch Epithelial Cell Control Kit is a Veridex product that incorporates Immunicon proprietary reagent technology and consists of two levels of controls, which are run daily to ensure that the CellSearch System for analysis of circulating tumor cells in the blood of cancer patients is operating properly. Immunicon and Veridex are in a development, license and supply agreement for development and commercialization of products using Immunicon proprietary rare cell detection and analysis technology in the field of cancer.
Impliant (Ramat Poleg, Israel) reported initiation of a multi-center clinical trial for its Cushion-Bearing Femoral Head. The first patient, an 86-year-old female, received the company's elastomer femoral head implant at Carmel Hospital in Israel, following recent CE mark approval. The Cushion-Bearing Femoral Head, based on a proprietary polyurethane material, is designed to resemble the body's natural joints more closely than current hard-bearing devices. The implant has a metal core with an elastomer cover that demonstrates excellent wear when articulating against native acetabular cartilage, according to Impliant. The randomized multi-center trial will compare the Cushion-Bearing Femoral Head to a traditional bipolar system in patients at Hadassah Hospital (Jerusalem); Assaf HaRofe Hospital (Tel Aviv); and Carmel Hospital (Haifa). Impliant said it would introduce the Cushion-Bearing Femoral Head through a limited rollout to European centers in 3Q04. Impliant says it is developing other implants based on the Cushion-Bearing Implant concept.
The FDA has cleared for marketing Intuitive Surgical's (Sunnyvale, California) da Vinci robotic surgical system to assist in coronary artery bypass surgery in which there is direct access to the chest using standard open-chest technique (sternotomy) or a smaller surgical incision (thoracotomy). The device already is cleared for general laparoscopic gall bladder and reflux disease surgery (including, for example, gall bladder surgery and reflux disease surgery), for general non-cardiac thoracoscopic chest surgery, and for thoracoscopically-assisted cardiotomy procedures (including, for example, mitral valve repair). The clearance follows the submission of data from a multi-center clinical trial involving use of the da Vinci to perform internal mammary artery anastomosis to the left anterior descending coronary artery. This indication broadens the use of the system, allowing surgeons in the U.S. to perform coronary artery bypass graft (CABG) surgery with small incisions.
McKesson Information Solutions (Alpharetta, Georgia) reported rollout of its new remote disease management and monitoring solution, Telehealth Advisor. With Telehealth Advisor, patients collect their vital signs using medical peripherals and transmit the readings to their provider via an easy-to-use electronic device connected to an ordinary phone line. Providers benefit by increasing the efficiency of their staff nurses while improving disease management and patient monitoring, the company said. The program also educates patients using 14 standard programs to manage chronic illnesses. Telehealth Advisor will be offered through a reseller agreement with Health Hero Network (Mountain View, California). McKesson will offer Health Hero's Health Buddy system as McKesson Telehealth Advisor and provide integration with McKesson's Horizon Homecare system, giving homecare providers a complete electronic medical record for their patients in one location.
Medtronic (Minneapolis, Minnesota) reported FDA approval and the commercial release of the InSync Maximo cardiac resynchronization therapy defibrillator system. With 35 joules of delivered energy and the industry's fastest charge times, InSync Maximo provides the highest margin of safety in treating sudden cardiac arrest, the company said. Like most recent Medtronic implantable defibrillators, the InSync Maximo system offers anti-tachycardia pacing options for pain-free termination of life-threatening fast ventricular tachyarrhythmias.
Medtronic MiniMed (Northridge, California) said that results of a study published in the July issue of Diabetes Care confirm that insulin pump therapy, using Paradigm pumps it makes improves glucose levels in children and adolescents with Type 1 diabetes over multiple daily injection therapy using long-acting Lantus insulin. The first-ever, randomized, 16-week trial included 32 patients, and was conducted by investigators from Yale School of Medicine (New Haven, Connecticut). Pediatric patients using Medtronic MiniMed's insulin pumps experienced a significant reduction in HbA1c levels (from 8.1% to 7.2%), whereas no significant change was reported in patients using multiple daily injections with Lantus (from 8.2% to 8.1%). All participants were using multiple daily injections prior to the study. At randomization, two patients from the pump group and one patient from the Lantus group met the American Diabetes Association's (Alexandria, Virginia) target HbA1c goal of 7% or below. At the end of the study, 50% of pump patients and only 13% of patients using multiple daily injections with Lantus met this goal. The study highlighted advantages of pump therapy, noting that basal rate settings (background insulin delivered to the patient around the clock) may have contributed to better blood sugar control in the pump group, and pump bolus history feature allowed investigators to review insulin increments previously delivered to patients and reinforce the need for pre-meal insulin to improve blood sugar control. Pump therapy participants also had a significant reduction in their total daily dose of insulin, whereas no significant reduction was found in the Lantus group.
Medtronic Vascular (Santa Rosa, California) reported that it had received the CE mark for its Interceptor PLUS Carotid Filter System. The Interceptor PLUS system can be used in combination with the Exponent Carotid Stent from Medtronic or other approved carotid stents to reopen blockages of the carotid arteries and improve blood flow to the brain, while reducing the risk of stroke by capturing embolic materials that can be freed during a stenting procedure. The filter features a simplified, intuitive delivery system that does not require the use of a sheath for deployment. The filter system is offered in sizes to fit vessel diameters from 4.25 mm to 6.25 mm, with a lesion crossing profile of only 0.036 inches. Its braided nitinol filter features excellent conformity to vessel walls.
MIV Therapeutics (Vancouver, British Columbia) reported that it has successfully completed the full range of biocompatibility studies on its proprietary, biocompatible hydroxyapatite (HAp) ultra-thin coating technology. The coating is designated for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. Toxikon (Bedford, Massachusetts) performed the complete range of 12 biocompatibility tests, the results of which included a test that found a Hap-coated stent to be non-toxic when implanted intramuscularly for 13 weeks.
Molecular Devices (Sunnyvale, California) reported the first shipment of the SynchroMax ET Plate Handling Robot, the latest addition to its line of microplate readers and liquid handling systems. The SynchroMax ET Plate Handler provides walk-away automation for ELISA workstations and cell-based screening units that include a Molecular Devices SpectraMax or Gemini microplate reader, AquaMax dispenser or Embla washer. With the SynchroMax ET, researchers can run up to 320 microplates uninterrupted in 96-, 384- or 1536-well formats, improving efficiency and freeing up valuable research time.
Neogen (Lansing, Michigan) said it has developed a method to read, store and analyze results from lateral flow tests – the only lateral flow test reader available on the market. AccuScan provides an easy method to objectively read, store, and analyze results from Neogen's Reveal line of lateral flow tests for Listeria, E. coli O157:H7, Salmonella, GMOs, mycotoxins, food allergens and ruminant material in animal feed. The AccuScan system consists of a lateral flow test reader combined with intuitive data management computer software. By inserting a test device into the reader and activating, the instrument takes a digital photograph of the test strip's results area. The reader then interprets the test's results, and if a line is detected, displays a line weight score. This process eliminates the subjectivity associated with lateral flow test interpretation, and provides an objective, traceable record of the test result, Neogen said.
North American Scientific (Chatsworth, California) said its Nomos Radiation Oncology Division has launched a new image-guided tracking feature incorporated into the company's BAT (B-mode Acquisition and Targeting) image guided radiation therapy technology. The new optical camera targeting solution expands BAT's clinical capability to image targets for therapeutic radiation treatment not only in the prostate, but also in breast, liver, pancreas, bladder, cervix and head and neck cases. Working in tandem with the optical camera is a newly developed and patented ultrasound probe tracker that will allow the user to navigate on multiple planes and at multiple angles. Coupled with the optical camera, the omni-directional probe allows clinicians to image soft tissue structures and their interface with other internal structures, providing the high-quality ultrasound imaging necessary for intensity modulated radiation therapy treatments, as well as conventional therapy.
Orthovita (Malvern, Pennsylvania) said it is entering a new "sub-market" niche with the introduction last month of its injectable Vitoss Scaffold Foam Flow, which the company said is an ultra-porous, versatile new form of the Vitoss line of biomaterials. The orthopedic biomaterials developer got clearance for the Vitoss Foam bone graft material in January, and this latest product is one in a series of about 12 products President and Chief Executive Officer Antony Koblish said the company will introduce this year and falls under that same 510(k) clearance. It is designed to help repair bone defects in the spine, extremities and pelvis, the company said.
Palatin Technologies (Cranbury, New Jersey) reported FDA approval to market NeutroSpec, an imaging agent indicated for the diagnosis of appendicitis in patients with equivocal signs. NeutroSpec will be marketed and distributed by Palatin's partner, Mallinckrodt Imaging (Hazelwood, Missouri), a unit of Tyco Healthcare. NeutroSpec, formerly known as LeuTech, is a radiolabeled monoclonal antibody product for imaging and diagnosing infections. NeutroSpec includes a technetium-labeled anti-CD 15 monoclonal antibody which selectively binds to a type of white blood cell, neutrophils, involved in the immune response. When injected into the bloodstream, NeutroSpec binds to neutrophils present at the infection site, labeling these cells with a radioactive tracer, enabling rapid imaging and detection of an infection using a gamma camera.
R2 Technology (Sunnyvale, California), a leader in computer-aided detection (CAD) in the mammography sector, reported that it has received FDA approval for its ImageChecker CT CAD Software system. The company said this is the first such system to receive an approval for CAD of solid lung nodules during review of multi-detector computer tomography (CT) chest exams. R2 said early lung cancer often presents as nodules and can be difficult to detect, and the hope is that, through earlier detection, there can be earlier treatment and better outcomes from treatment. For the new system's submission to the FDA, R2 completed a clinical trial which showed significance in radiologists performance using the CAD system. In this study, radiologists were asked to review CT scans of lungs using visual analysis only, or in other words, relying on their own analysis of the scan without CAD. Then, they were asked to employ the ImageChecker CT CAD software system for a second analysis of those same scans, and then respond to the findings using the ImageChecker CT CAD system either positively or negatively. Those studies showed that, with significance, the radiologists' performance improved with the use of the CAD system vs. just their performance alone, the company said.
Sicel Technologies (Morrisville, North Carolina), has received FDA clearance to market its OneDose surface dosimeter, a device designed to provide real-time, continuous data on the physiology of a tumor. The wireless, pre-calibrated, patient dosimetry system developed using Sicel's patented technology in response to the physicists' demands for an accurate and economical method of obtaining immediate verification and quality control of patient treatment plans. Michael Riddle, chief operating officer and recently appointed president of Sicel Technologies, said, "This is Sicel's first cleared product and one on which we hope to build the foundation for our future growth."
Siemens Medical Solutions (Malvern, Pennsylvania) said it has received an "approvable" letter from the FDA for the Mammomat NovationDR, a full-field digital mammography system. The FDA indicated in the letter that the Mammomat NovationDR is approvable for release to the market, pending the successful completion of an FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and completion of the labeling for the system. The Mammomat NovationDR provides digital screening, diagnosis, and stereotactic biopsy capabilities in one system. It features a flat panel detector based on amorphous Selenium technology, enabling a direct conversion of X-ray to digital information. At 25 cm by 29 cm, the size of the Mammomat NovationDR image detector enables imaging of a wider range of patient breast sizes. The system also features an acquisition workstation and the MammoReportPlus, a dedicated soft copy reporting workstation that allows fast loading times.
Smith & Nephew Endoscopy (Andover, Massachusetts) reported U.S. commercial launch of its Electrothermal 20S Spine System. The system includes a new, multi-functional generator that provides controlled levels of thermal energy for treating chronic lower back pain. It is for use with the company's current minimally invasive therapies and in conjunction with its new procedure to treat neck and back pain resulting from painful facet (spine) joints. The Electrothermal 20S generator – which at 12.6 pounds is highly portable – was designed with an autoprobe recognition feature that immediately determines which device is plugged in and then automatically adjusts to default settings for that procedure. The generator also provides an interactive on-screen intelligence feature, providing the user with information and trouble-shooting capabilities.
Sub-Q (San Clemente, California) has received FDA approval for its SureStat Arterial Closure System. It said SureStat is the next generation of closure technology approved in the U.S. for the "extravascular" or outside the vessel closure of femoral arteries following diagnostic or interventional vascular procedures. The SureStat is designed to be easily positioned to deliver the hemostatic material T-Foam, an enhanced and rapidly resorbable gelatin sponge. SureStat can close 8 Fr and smaller punctures in the femoral artery following diagnostic or interventional catheterization procedures. SureStat reduces time to hemostasis, time to ambulation and time to eligibility for hospital discharge, Sub-Q said.
Vision-Sciences (Natick, Massachusetts) said it has received the CE mark for its CST-2000 Cystoscope with Slide-On EndoSheath System and its ENT Sensory EndoSheath for sensory testing, and is ready to market the products in Europe. The CST-2000 allows physicians to visualize the bladder with a flexible endoscope that is passed through the urethra. The CST-2000 with Slide-On EndoSheath System combines a high-performance flexible endoscope with a disposable sheath that contains the working and irrigation channel and ensures a sterile insertion tube for each patient procedure. The ENT Sensory EndoSheath provides an alternative to the modified barium swallow procedure of sensory testing. Sensory testing using the EndoSheath is generally performed in five minutes, and has been shown to be as sensitive and specific as a 24-hour pH test for the diagnosis of acid reflux disease that affects the throat and vocal cords.
Viasys Healthcare (Conshochocken, Pennsylvania) reported that it is marketing the LYRA CPAP nasal interface, designed to maximize patient comfort. The mask can be oriented in different positions based on patient preference, and several different size nasal inserts are included in each kit, allowing the patient to select the most comfortable size. The design is intended for quiet operation, even at higher pressures.
Xillix Technologies (Richmond, British Columbia) completed its international Onco-LIFE lung cancer clinical trial and expects to submit its premarket approval supplement to the FDA in the next few weeks. Onco-LIFE incorporates Xillix's fluorescence endoscopy with conventional white-light endoscopy for the detection and isolation of lung cancer.