InSightec (Haifa, Israel) has received premarket approval for its ExAblate 2000 system for non-invasive surgery for uterine fibroids, making it the first focused ultrasound thermal ablation system approved by the FDA and the first focused ultrasound surgery system using magnetic resonance (MR) guidance approved by the agency. Uterine fibroids are the most common non-cancerous tumor in women of child-bearing age, and the National Institutes of Health (NIH; Bethesda, Maryland) has said that at least 25% of women suffer from the condition. Symptoms include heavy bleeding or painful periods, bleeding between periods, pressure on the lower abdomen, frequent urination, pain during sex and lower back pain. Although the NIH said as many as 77% of women may have uterine fibroids, not all of them are symptomatic.
The FDA noted that it had "expedited review of the device because it offers significant advantages over existing treatments for uterine fibroids." Those options include hysterectomy, hormone therapy, myomectomy and fibroid embolization.
Rob Newman, vice president of InSightec-North America (Dallas), said that ExAblate is an "alternative to hysterectomy," although it is not yet ready for women who still want to have children. The FDA emphasized that the device is intended to "treat women who have completed child-bearing or do not intend to become pregnant." But making it available to women who still may want to become pregnant may not be too far off in the future, the company said.
Elsewhere in the product pipeline:
The diagnostics division of Abbott Laboratories (Abbott Park, Illinois) has expanded the product offering for its AxSYM automated immunoassay system with an updated test for the detection of cardiac troponin. The new AxSYM Troponin-I ADV replaces Abbott's current troponin test. The company said the new assay provides initial results within 15 minutes and offers improved detection of cardiac troponin, a protein released from dying heart muscle cells that are deprived of blood flow during a heart attack. Development of the updated assay took roughly 16 months, and the company plans to phase out the older test.
The same back-and-forth motion parents use to rock their babies is the basis behind the AT-101 passive exercise device from Acceleration Therapeutics (North Bay Village, Florida), a division of Non-Invasive Monitoring Systems (NIMS; also North Bay Village). The AT-101 is a horizontal platform that moves the body repetitively in a back-and-forth motion from head to foot, thus aiding in improving circulation and joint mobility. And it may have other therapeutic results as well. "We're moving every part of the body," said the device's inventor and company president Marvin Sackner, MD. The device is used primarily by patients with neurological diseases, especially those with limited mobility, he said. Each treatment lasts about 30 to 45 minutes, and provides symptomatic relief that requires repeated treatments. The AT-101 is essentially a moving mattress mounted on a hospital-like gurney. The patient is placed on the platform and is connected to it, at the feet, by sandal-like straps. The device then moves the patient back and forth, head to foot, about 140 times a minute. The motion, Sackner says, moves the diaphragm and produces an accelerated blood flow to various crucial organs.
Advanced Brain Monitoring (Carlsbad, California) has been cleared by the FDA to provide a service that will allow for the diagnosis of obstructive sleep apnea (OSA) without patients having to leave the comfort of their own bed and spending the night or nights in a hospital sleep lab. The service, called the Apnea Risk Evaluation System (ARES), combines a miniaturized, batter-powered device to measure blood oxygen levels, pulse rate, snoring sounds, nasal pressure and head position and movement. It also includes a questionnaire to assess known risk factors. OSA is characterized by snoring and interrupted breathing, with patients waking perhaps hundreds of times during the night, causing them to lose sleep. The company said that in a multi-site clinical trial that included direct comparisons with laboratory testing and in-home studies on 280 patients, it was proven that ARES "was as accurate as the gold standard laboratory sleep study." The National Sleep Foundation (Washington) estimates that more than 18 million Americans have OSA and 90% are undiagnosed.
The FDA has cleared the way for Applied Digital Solutions (ADS; Delray, Florida), through a wholly owned subsidiary, to market an implantable chip that is designed to provide easy access to patients' medical records. ADS and Digital Angel (South St. Paul, Minnesota), which makes the device, said the VeriChip is the world's first implantable radio frequency identification (RFID) microchip for human use. The FDA clearance follows the completion of a de novo application review. The company has said it believes the VeriChip has the potential to save lives and limit injuries resulting from medical errors in the hospital setting. The VeriChip health information microtransponder system consists of an implantable RFID microtransponder, an inserter, a hand-held scanner and a secure database containing the patient-approved healthcare information. The device, about the size of a grain of rice, is a subdermal radio frequency microchip. Inserted under the skin in a brief outpatient procedure, each chip contains a unique 16-digit verification number that is captured by briefly passing a scanner over the insertion site. The captured 16-digit number links to the database via encrypted Internet access. The previously stored information is then conveyed via the Internet to the registered requesting healthcare provider.
Beckman Coulter (Fullerton, California) said its stemCXP system, a new software module for stem cell monitoring, will be available on its FC 500 CXP flow cytometry system. The application, along with the previously announced tetraCXP system used for HIV monitoring, has been validated for in vitro diagnostic use. The system, comprised of stemCXP software for FC 500 flow cytometry systems with CXP software, Stem-Kit Reagents, quality control and standardization reagents, provides automated analysis of various blood cell populations. The stemCXP System is designed to simultaneously identify and enumerate CD45+ and CD45+/CD34+ dual positive cell populations, key indicators found in the blood of leukemia and lymphoma patients.
Binax (Portland, Maine), a developer of rapid diagnostic tests, said that the FDA has granted 510(k) clearance for the NOW Influenza A & B test. This latest test from Binax replaces two individual tests, NOW Flu A and NOW Flu B, and complements the company's portfolio of diagnostic tests for respiratory tract infections. It said NOW Influenza A & B is an easy, one-step test that is as simple to read as a pregnancy test. Noting that performance is comparable to NOW Flu A and NOW Flu B tests currently on the market, Binax said the advantage of the new test is the ability to identify both flu A and flu B and differentiate between the two using one simple device.
Boston Scientific (Natick, Massachusetts) reported in late October the start of enrollment in the ARRIVE 2 registry program, which plans to enroll 5,000 patients at about 60 centers in the U.S. The program is designed to collect and analyze "real world" safety and clinical outcomes data from the Taxus Express2 paclitaxel-eluting coronary stent system in the treatment of patients with coronary artery disease. Separately, Boston Scientific said it has launched a full line of mid-urethral sling products for the treatment of female stress urinary incontinence. The products provide alternative approaches for the placement of mid-urethral slings, a device that provides support on the pelvic floor to help a woman maintain urinary continence and avoid unintended leakage. The three new products include the Advantage System, designed for the placement of mid-urethral slings via transvaginal delivery, an approach used by many gynecologists and urogynecologists; the Lynx System, designed for the placement of mid-urethral slings supra-pubically (from the abdomen downward), an approach used by many urologists; and the Obtryx System, designed for the placement of mid-urethral slings via the transobturator approach (laterally through the pelvis), an approach Boston Sci said is gaining popularity among urologists, urogynecologists and gynecologists. Each of the products uses the Advantage Mesh sling, which the company said is appropriate for all three types of mid-urethral sling procedures, regardless of the physician's delivery choice.
BrainLAB (Munich, Germany) reported the introduction of a new technology to Rush University Medical Center (Chicago) that helps avoid damage to muscles and ligaments in total knee replacement and reduces the size of the incision by 50%. The patient benefits by regaining the ability to walk and bend the leg as early as the first day after the operation. The new operating technique combines Image-Guided Surgery with BrainLAB's VectorVision navigation system, and a new knee implant from Zimmer Holdings (Warsaw, Indiana).
Cardiac Science (Irvine, California) reported that data from a study published in Resuscitation in October demonstrates that its in-hospital Powerheart Cardiac Rhythm Module (CRM) technology not only is safe and effective, but significantly shortens hospital response time to sudden cardiac arrest (SCA). Because the time to defibrillation is the most critical determinant to patient survival, the study results indicate that the CRM technology can significantly improve the outcomes of hospital patients stricken with SCA. The Powerheart CRM is designed to be prophylactically attached to an at-risk cardiac patient, continuously monitor a patients heart, detect the onset of a life-threatening arrhythmia and automatically deliver defibrillation therapy to patients suffering from SCA, without the need for human intervention. Study authors concluded that the evidence suggests the use of the Powerheart on cardiac patients throughout the hospital presents the possibility of providing consistently rapid identification and response to life-threatening arrhythmias.
Competitive Technologies (CTT; Fairfield, Connecticut) reported that U.S. patent No. 6,808,561 has been issued by the U.S. Patent and Trademark Office for Dr. Brian Genge's nanotechnology bone biomaterial developed at the University of South Carolina (USC; Columbia, South Carolina). CTT has an exclusive agreement with the USC Research Foundation to license and commercialize the nanotechnology, an injectible calcium phosphate-based biomaterial. The patented nanotechnology has applications in dentistry, human orthopedic procedures and veterinary uses. The bone biomaterial technology is a flowable, moldable paste that conforms to and interdigitates with the host bone. It rapidly hardens itself in vivo, forming a solid bone-like structure capable of stabilizing fractured bone within 15 minutes and supports the growth of cartilage and bone cells.
CryoCor (San Diego) reported receiving FDA 510(k) clearance for the Breva Surgical Probe, part of its Cardiac Cryoablation System, which includes a control console and a probe/console interface. The Breva Surgical Probe is intended to be used by cardiothoracic surgeons for the treatment of arrhythmias. The device works through cryoablation, the application of extreme cold to ablate or destroy electrically abnormal cardiac and vascular tissue. The Breva Probe will be used under direct visualization to perform cardiac cryoablation procedures in the surgical setting.
Dolbey (Cincinnati) has released Fusion Expert, its latest speech recognition solution. Fusion Expert is based on the Philips SpeechMagic technology and is a component of the Dolbey Fusion suite of products, which includes Fusion Text transcription software, Fusion Voice dictation and Fusion Speech background speech recognition. Dolbey said Fusion Expert is available in many different contexts, including radiology, pathology, emergency medicine and other general medical fields.
Endologix (Irvine, California) received a conditional approval letter from the FDA, allowing it to commercially distribute the Powerlink system, an endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA). The conditions of approval require the standard continued post-marketing surveillance and annual update reports to the FDA and physician users, the company said in a statement. "Use of ELGs allows patients to avoid invasive surgery that carries well-documented high rates of morbidity and mortality by opting for a minimally invasive procedure," said Paul McCormick, president and CEO of Endologix. "U.S. patients with AAA will have access to our ELG that addresses many shortcomings of devices currently on the market," he said An abdominal aortic aneurysm is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, left untreated, becomes increasingly susceptible to rupture. When an AAA ruptures, patients experience pain in the abdomen and back, fainting and loss of consciousness frequently leading to shock and death. The mortality rate for ruptured AAAs is estimated to be about 75%. The incidence of AAA increases with age. Endologix estimates that 1.7 million Americans have AAA, yet only about 220,000 are diagnosed each year. About 70% to 80% of diagnosed AAA patients do not have symptoms at the time of initial diagnosis, and AAAs are generally discovered inadvertently during procedures to diagnose unrelated medical conditions. The company estimated that each year about 50,000 to 60,000 of U.S. patients diagnosed with AAA undergo "highly invasive" conventional open surgery, 15,000 to 20,000 are treated with commercially available ELGs, while their physicians monitor the remainder. With conventional AAA open surgery, surgeons repair the rupture by replacing the affected portion of the aorta with a graft. This procedure is performed under general anesthesia and requires a large abdominal incision, an average hospital stay of eight to 15 days and convalescence of eight to 12 weeks.
ev3 (Plymouth, Minnesota) has received 510(k) clearance from the FDA for the use of the company's Protege GPS Nitinol Self-Expanding Long Stents to treat malignant biliary strictures. The stents are used during a minimally invasive procedure to open strictures and blockages. The Protege GPS Long Stents also are expected to receive CE-mark approval for use in Europe to treat biliary strictures and peripheral vascular disease, including the iliac artery. The product will be offered in lengths up to 150 mm. The company said using one stent, rather than several shorter stents, simplifies the placement procedure and reduces the risk of complications. The Protege GPS is made of nitinol.
Galls (Lexington, Kentucky) said it has expanded its Dyna Med line of products, introducing several new devices for patient transport that are easier to use and more comfortable for patients. New products include Dyna Med X frame and H frame cots with adjustable collapsing head ends, backrests, safety catch releases and side rails; Dyna Med emergency stretchers with D-rings, allowing for the use of speed clips to secure patients more quickly and easily; a Dyna Med folding pole stretcher that folds into four parts and is stored in a nylon bag that can be carried as a backpack; a new Galls basket stretcher, designed for rescue situations in rugged locations with a polyethylene plastic shell with a permanently attached heavy-duty aluminum frame; and an enhanced Dyna Med HARE traction splint with the ability to rapidly set the splint length with improved collett locks, a larger traction knob for better grip and control, the ability to adjust traction with one hand, and a recessed traction release button to help prevent accidental release.
GE Healthcare (Waukesha, Wisconsin) reported the introduction of a new high-performance compact ultrasound system, Logiq Book XP, with expanded capabilities for the emergency room and surgery. Weighing just 10 pounds, the easy-to-use ultrasound system has advanced imaging and connectivity features that enable clinicians to scan patients virtually anywhere. Logiq Book XP is built on GE's software-based TruScan architecture and patented miniaturization technologies to provide the capacity to store more than 30,000 clinical images. The system provides fast acquisition speeds and new digital beam-former transducer technologies to deliver high quality images for a range of applications. The system's user-friendly interface, personalized preset functionality and common Logiq family keyboard make it a practical solution for virtually any clinical environment, the company said. Logiq Book XP offers the latest integrated networking, image storage and wireless connectivity.
Guidant (Indianapolis) said it has begun enrollment in CAPTURE (Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple specialties. The study will use Guidant's carotid stent and embolic protection system. As announced in a final decision recently, the Centers for Medicare & Medicaid Services (Baltimore) will provide expanded payment coverage to include high-risk patients treated as part of this and other FDA-required post-approval studies of carotid artery stenting. Guidant is currently is the only company with a carotid stent and embolic protection system on the market in the U.S. CAPTURE is part of the company's post-approval study plan that will include at least 1,500 patients receiving the Acculink Carotid Stent System and Accunet Embolic Protection System at about 150 sites in the U.S. The primary endpoint of the study will be a composite of stroke, death and heart attack at 30 days following the carotid stenting procedure.
I-Flow (Lake Forest, California) said that its ON-Q brand has received CE-mark approval for additional indications for use within the European Union. ON-Q PainBuster and ON-Q C-bloc, narcotic-free post-surgical pain relief systems, originally received CE-mark clearance for the delivery of local anesthetic to the surgical site and nerve blocks, respectively. These additional indications are identical to the FDA clearance that ON-Q received in May, and allow I-Flow to market ON-Q as superior to narcotics alone for reducing pain after surgery. Currently, all ON-Q branded products sold within the U.S., the European Union and Canada are cleared to carry this enhanced labeling. The expanded indications also enable I-Flow to label the device for specific surgeries.
Kensey Nash (Exton, Pennsylvania) said it has received a comment letter from the FDA related to its application for 510(k) clearance for its TriActiv System. The company said it is preparing its response to the letter and intends to file a response within a short period of time. Based on the nature of the comments, Kensey Nash said it continues to anticipate FDA approval for the TriActiv by year-end. The 510(k) application contains data from the PRIDE (Protection during saphenous vein graft Intervention to prevent Distal Embolization) trial which randomized the TriActiv System against other approved embolic protection systems or the standard of care, and measured major adverse cardiac event rates in the treatment of saphenous vein graft disease. The embolic protection system is designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events.
Medicsight (Boston) reported receiving FDA clearance for Medicsight Colon CAR 1.2, an image analysis software tool designed to be used with CT colonography, or virtual colonoscopy, to assist radiologists in searching for and measuring potential colorectal polyps. The system works by using Medicsight's Computer Assisted Reader (CAR) technology to deploy a series of filters against image data derived from CT colonographies. These filters highlight spherical areas of the image as small as 5 mm. The radiologist also is able to manually highlight any irregularities for closer inspection. Once suspect polyps are found, the software can precisely identify the boundaries and features and show them in 3-D with a volume measurement, diameter, shape and location. The company said its Colon CAR 1.2 is the first "joint read" software available for CT colonography.
Medtronic Sofamor Danek (Memphis, Tennessee) reported the commercial release of its Hourglass Vertebral Body Spacer, for insertion between vertebrae in the anterior thoracic and lumbar spine to aid in surgical spinal correction and stabilization. The company made its announcement at the Congress of Neurological Surgeons meeting in San Francisco. The Hourglass Spacer is designed to replace and restore the height of all or part of a vertebral body that has been removed for the treatment of tumor or trauma. The product is a narrow bullet-shaped implant that Medtronic said allows for more accurate anatomical matching and restoration of normal spinal balance. The spacer is labeled for use with many Medtronic spinal fixation systems and allows sufficient room for bone graft packing, the company said.
Medwave (Danvers, Massachusetts) said a study examining the utility of its Vasotrac non-invasive blood pressure monitor, primarily in regard to its intrusiveness after prolonged continual readings, was recently published in the Journal of Psychosomatic Research. The study concluded that the Vasotrac is non-intrusive during extended wear, as well as capable of producing a sampling rate that far exceeds that of other methods for non-invasive blood pressure assessment in a research environment.
Nellcor (Pleasanton, California) reported the unveiling of the Mallinckrodt LaryngoSeal Laryngeal Mask at the annual meeting of the American Society of Anesthesiologists in Las Vegas. The company said the single-use LaryngoSeal Laryngeal Mask eliminates the challenges of reusable masks at a comparable cost per use. The mask comes in eight sizes to fit neonatal through adult patients. Features include a reinforced tip; an integrated inflation line that keeps the line secure and conveniently located; and an aperture that allows easy passage of bronchoscopes and suction catheters.
Nikon Instruments (Melville, New York) reported the addition of two new illumination systems to its family of imaging products. The Nikon White Light Total Internal Reflection Fluorescence (TIRF) illuminator is a cost-effective alternative to traditional laser based systems, the company said. The Nikon White light system is multi-spectral, allowing for all light wavelengths to be available with standard microscopy fluorescent filters. The new system provides bright illumination with perfect chromatic correction, Nikon said. It can quickly and easily switch between TIRF, variable angle oblique, and standard epi-fluorescence illumination, making it a versatile tool for research imaging, the company added. Also new from Nikon is the Laser TIRF System II, which combines epi-fluorescence and TIRF on the same optical level. The new design leaves the upper level of the TE2000 illumination path free for additional applications, and makes it possible to switch between both modalities in milliseconds. This new system provides a significantly larger and more even field of view than its predecessor.
Olympus (Melville, New York) said it has introduced the DSU spinning disk confocal system, designed to provide optical sectioning and motorized operation with the flexibility of an arc lamp excitation source. The DSU system uses the company's slit disk technology to offer enhanced signal transmission. Disk operation is motorized, allowing a computer to switch remotely between widefield and confocal imaging modes. The system offers full-frame CCD image capture at 15 to 20 frames per second with a streamlined single-disk, opto-mechanical design. Five disks are available, each with varying slit width and spacing. The system can be combined with a motorized microscope for 3-D confocal imaging and other applications.
St. Jude Medical (St. Paul, Minnesota) reported the first European implant of its new SJM Tailor Annuloplasty Band for use in heart valve repair procedures. The implant was performed by Hans-Joachim Schafers, MD, at the University of Saarland (Homburg/Saar, Germany), on a 57-year-old woman suffering from mitral valve endocarditis. Schafers said the patient is doing well and the device is performing as expected. The SJM Tailor Band, launched in the U.S. in July, is a flexible band that accommodates the natural movement of the mitral valve annulus. It can be used in both mitral and tricuspid heart valve repair procedures. The SJM Flexible Annuloplasty Delivery System allows easy implantation of the SJM Tailor Band with a one-step, push-button release, St. Jude said. The handle quickly and securely attaches and detaches, while an extension handle offers an alternative for minimally invasive procedures. Malleable nitinol alloy sections of the holder and sizers are easily shaped, yet revert to their original form during heat sterilization.
Theragenics (Buford, Georgia) reported treatment of the first patient in the TheraSight Trial at Emory Eye Center (Atlanta). The trial is designed to evaluate the safety and feasibility of the TheraSight Ocular Brachytherapy System for the treatment of sub-foveal choroidal neovascularization associated with exudative (wet) age-related macular degeneration. It is a pilot study of three doses of radiation delivered to 30 patients at up to six clinical sites. Theragenics said favorable results of the study may be used to expand to a larger pivotal trial designed to further test the safety and effectiveness of the system. The company is the manufacturer of the TheraSeed palladium-103 cancer treatment device.
Varian (Palo Alto, California) reported the availability of OnTrak OraTube, which combines the convenience of onsite oral fluid collection with laboratory- certified results. OraTube is an extension of the company's drugs of abuse oral fluid test product line and complements OnSite OraLab, whereby sample collection and results can be obtained onsite. The OraTube is drip-free, simple-to-use and includes three quick steps from sampling to shipping. Non-invasive and 100% observable, the collection process nearly eliminates specimen tampering and simplifies chain-of-custody procedures. To complete the testing process, users ship the OraTube collector to an OraTube-certified drug testing facility. Negative results are available within 24 hours, and accurate, laboratory-certified confirmations are available within 48 to 72 hours. OraTube is used for pre-employment testing, random suspicion or post-accident testing and screening for amphetamines, cocaine, methamphetamine, MDMA, morphine, PCP and THC.
Vasomedical (Westbury, New York) reported that Phase 2 of the International EECP Patient Registry (IEPR-2) has met its enrollment target of 2,500 patients. IEPR-2 collects additional data to better characterize angina patients with coexisting heart failure and other conditions. Forty-seven centers that provide treatment with Vasomedical's EECP (enhanced external counterpulsation) systems across the U.S. participate in this voluntary registry, enrolling and following consecutive patients treated for angina pectoris. With the completion of enrollment for IEPR-2, physicians will gain additional information from the real-life experiences of cardiologists using EECP therapy to treat angina patients with heart failure. Patients are characterized by their demographics, medical history, symptom status and perceived quality of life immediately before EECP therapy, and at six, 12 and 24-months post-therapy. The registry also captures data on medication use, emergency room visits, hospital admissions and subsequent invasive treatments.
VNUS Medical Technologies (San Jose, California) reported the introduction of RFG2, its next-generation radio frequency (RF) generator used in the Closure procedure. The RF generator is a significant element of the Closure System and is used in conjunction with the Closure PLUS catheter for the treatment of saphenous vein reflux.