Boston Scientific (Natick, Massachusetts) reported the first U.S. human use of its FilterWire EX embolic protection device and Carotid Wallstent Monorail device, as part of its FDA-approved clinical trial designed to evaluate the benefits of stenting in conjunction with embolic protection to treat carotid artery disease. The procedure was performed at the Arizona Heart Institute and Foundation (Phoenix, Arizona).
The trial will enroll as many as 775 patients at up to 40 U.S. sites. The FilterWire EX embolic protection device is a low-profile filter, mounted on a rapid exchange deployment system, designed to capture embolic debris that is released during a procedure to prevent it from traveling to the brain.
Boston Scientific also reported completing the investigational arm of a clinical trial designed to evaluate uterine artery embolization (UAE) for the treatment of uterine fibroids. It was completed in a year using Contour PVA particles and the FasTracker Microcatheter system. The data from the investigational arm will be compared to data from the control arm, which uses myomectomy, a standard surgical treatment. By depriving the fibroid of its blood supply, UAE may dramatically reduce the symptoms associated with uterine fibroids.
Elsewhere in the product pipeline:
AMDL (Tustin, California) authorized clinical studies to be conducted at three cancer centers in Germany for its DR-70 cancer detection test kit. These studies are scheduled to be completed in 2Q02. AMDL developed the DR-70 noninvasive cancer blood test, which has demonstrated its ability to detect the presence in humans of up to 13 cancers — including lung, colon, breast, stomach, liver, rectum, ovary, cervix, esophagus, thyroid, pancreas, trophoblast and malignant lymphoma — 84% of the time overall. Clinical trials of the DR-70 have been conducted in China, Canada, Taiwan and Turkey.
Artecel Sciences (Durham, North Carolina) and Duke University Medical Center (also Durham) researchers reprogrammed adult stem cells taken from a deposit of fat behind the kneecap into functioning cartilage, bone or fat cells that potentially could be grown into replacement tissues. Researchers took the fat pads from patients whose knee joints were removed during total joint replacement surgery. Last year the research team reported the ability to turn fat cells taken from liposuction procedures into cartilage cells.
Bayer Diagnostics (Tarrytown, New York) launched its Multistix PRO Reagent Strips, a "ratio" urinalysis test to enable physicians to more conveniently assess undiagnosed or at-risk kidney disease. The launch coincided with the National Kidney Foundation's new guidelines that urge physicians to identify and treat kidney disease in at-risk patients. Multistix PRO strips advance dip-and-read urinalysis technology using a protein to creatinine ratio to significantly reduce false results. Multistix PRO strips measure the urinary concentration of protein, with a sensitivity of 8-15 mg/dL, using an assay method less affected by interferences (e.g., specific gravity and pH) that can affect other dipstick protein tests. Multistix PRO strips also measure the level of creatinine. The ratio corrects for variations in the concentration of the urine. After dipping in a urine sample, the Multistix PRO strips can be read by a Clinitek 50 Analyzer in a physician's office in 60 seconds.
Biocoral (New York) received approval for its Autologous Biological Surgical Glue patent from the Canadian Intellectual Property Office. The fully autologous fibrin glue is prepared using the patient's blood in a close system, eliminating immunological problems and the risk of blood-born disease transmission such as HIV and Hepatitis. The company said all fibrin glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolytic agents, the company said.
Biophan Technologies (Rochester, New York) filed four patent applications, offering improvements to the pacemaker field, including catheter design, electrode materials, and hermetic sealing of components. These patents cover both traditional metal leads, used in today's pacemakers to connect the pacemaker to the heart, and the company's new fiber optic lead, which eliminates all the known causes of pacemaker safety issues associated with the use of MRI imaging. Current pacemakers are contraindicated by both the FDA and manufacturers for use with MRI equipment. Problems can occur when radio frequencies used in MRI encounter the wire lead connecting a pacemaker to the heart. Other patents involve extending the battery life of the fiber optic solution, which uses somewhat more energy than a wire solution. Biophan said it is working on extensions of its technology to other medical devices that are susceptible to MRI.
Bonutti Technologies (Effingham, Illinois) released a new approach to endoscopic suturing, the Unity Ultrasonic Fixation System, which secures a range of sutures with the low-profile Unity Fixation Seat. Ideal for braided sutures, the Unity System spreads the compressive load over a larger area to prevent tissue tearing. The system recently received a determination of substantial equivalence from the FDA. Indications for use comprise general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used. The Unity Fixation Seat meets the knot strength standards for surgical suture.
The Bracco Group (Milan, Italy), a diagnostic imaging developer, is offering a noninvasive system of prenatal diagnosis for Down's syndrome to the Italian market through a collaboration and licensing agreement with Ikonisys (New Haven, Connecticut). The noninvasive technology, in comparison to amniocentesis testing, consists of a blood test used to identify trisome 21, found in the rare fetal cells circulating in the mother's blood stream from the first weeks of pregnancy on. The system identifies the target cells by means of combining an automated microscope with the most advanced molecular biological technology available. This method would offer a significantly earlier diagnosis (in the 11th week of pregnancy, as opposed to the 15th), fewer potential complications for both mother and fetus due to a clearly less-invasive technique, and a major cost savings (up to 75% less). Bracco will manage all clinical development for the product inside Italy, together with Ikonisys.
CADx Medical Systems (Laval, Quebec), a subsidiary of Shire Pharmaceuticals Group plc, received FDA approval for its Second Look computer-aided detection (CAD) system that improves breast cancer detection. The data reviewed by the FDA were generated in a multicenter study of over 9,000 patients performed at 18 U.S. institutions. In the clinical trials, 26.2% of breast cancers missed would be detected with the use of Second Look, the company said. Second Look provides radiologists with a computerized second review of mammograms, highlighting potential areas of concern on a mammagraph report, calling attention to subtle changes in tissue that may indicate the presence of cancer. Second Look is a standalone computer system designed to integrate into the patient's traditional work-up as well as the radiologist's current workflow.
Candela (Wayland, Massachusetts) introduced its C-beam pulsed dye laser last month at the annual meeting of the American Academy of Dermatology in New Orleans, Louisiana. The company said the laser's parameters (585 nm wavelength and .45 ms pulse duration) are well suited for psoriasis and scar treatment. In psoriasis treatment, the C-beam penetrates below the epidermal surface, through the psoriatic plaque, directly to the overdeveloped capillary bed below that supplies blood, oxygen and nutrients to the plaque from within to create heat within these microvessels and ablate the vessel. Treatment can destroy the structure of the plaque, leaving new, clear epidermis. Treatment of new surgical incision scars includes all plastic surgery (particularly facelifts), abdominal, breast, Cesarean sections, sternotomies, small telltale scars from liposuction and other less invasive procedures, and others. The C-beam procedure requires a minute or two, and is typically delivered in three treatments at two-week intervals.
Cardiac Science (Irvine, California) received 510(k) clearance to market its Powerheart AED (automated external defibrillator), a public-access defibrillator for the emergency treatment of victims of sudden cardiac arrest. The Powerheart AED incorporates Cardiac Science's RHYTHMx technology, which powers its Powerheart CRM fully-automatic hospital bedside monitor-defibrillator. As a result, the company was granted FDA clearance for new indications including the elimination of the need for the rescuer to determine whether or not the cardiac arrest victim has a pulse prior to attaching the defibrillator device. Powerheart also is cleared for continuous monitoring of a conscious victim's heart rhythm after revival, protecting the victim against the recurrence of a post-resuscitation life-threatening arrhythmia until hospital admittance.
CenterWatch (Boston, Massachusetts) launched a new printed reference resource designed for patients and professionals to identify active clinical trials. In association with the Physicians Desk Reference, this directory will be available through several thousand public and specialty libraries throughout the U.S. Distribution of this first edition was supported by a grant from Amgen (Thousand Oaks, California). The new directory provides information for consumers and health professionals interested in identifying medical treatments in development that have not yet been approved by the FDA. The directory lists more than 7,500 clinical trials that are actively seeking volunteers across more than 600 diseases and conditions. The listings will be updated quarterly. CenterWatch, an information services company that focuses on the clinical trials industry, is a sister company to American Health Consultants, which publishes The BBI Newsletter.
Compugen Ltd. (Tel Aviv, Israel) discovered two novel prostate-specific proteins encoded by alternative mRNA splice variants of the genes for prostate specific antigen (PSA) and its related protein, human kallikrein 2 (hK2). The novel transcripts were predicted using Compugen's LEADS computational biology platform and then verified in the company's molecular biology laboratory. These novel proteins may have important applications in developing additional diagnostic tools for prostate cancer and for understanding the pathobiology of the disease. The discovery was published in the Journal of Biological Chemistry.
COR Therapeutics (South San Francisco, California) said the Journal of the American Medical Association reported that one year following intracoronary stenting, patients who received Integrilin (eptifibatide) injection in addition to traditional care continued to benefit from a significant reduction in the combined incidence of death or heart attack. Integrilin helps prevent reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets that are responsible for thrombus development. The publication reported that the combined incidence of death or heart attack was significantly reduced from 12.4% with placebo to 8% with Integrilin. A consistency of benefit was reported regardless of patient age, weight, sex, clinical condition, or presence or absence of diabetes. Follow-up vital status information was available for 98.1% of all patients at 12 months. The incidence of death or heart attack at one year in diabetics was reduced from 13.4% with placebo to 7.8% with Integrilin and from 12.0% with placebo to 8.1% with Integrilin in non-diabetic patients.
CryoLife (Kennesaw, Georgia) was awarded the CE mark for its BioGlue surgical adhesive for use in general surgery procedures, representing the third CE mark for surgical application of BioGlue within the European Union. This extends application of BioGlue for soft tissue repair including cardiac, genitourinary, dural, alimentary tract (which includes esophageal, gastrointestinal, and colorectal tissues) and other abdominal soft tissues, such as pancreatic, splenic, hepatic, and biliary. BioGlue is approved for cardiac, vascular and pulmonary repair in 36 countries outside the U.S. BioGlue has been approved by the FDA for application as an adjunct to standard methods of achieving hemostasis in adult patients in the surgical repair of large vessels such as aorta, femoral and carotid arteries.
Curon Medical (Sunnyvale, California) published results of a multicenter U.S. clinical trial evaluating the safety and long-term efficacy of its Stretta System for the treatment of gastroesophageal reflux disease (GERD). Positive data from the study were published in Gastrointestinal Endoscopy, the journal of the American Society for Gastrointestinal Endoscopy. The open-label, 118-patient study evaluated a group of severe GERD patients who, on average, required twice-daily proton pump inhibitor medication to control symptoms of heartburn. The study said Stretta improves GERD symptoms, quality of life and esophageal acid exposure, and eliminates the need for anti-secretary medications in the majority of patients at 12 months.
Diametrics Medical (St. Paul, Minnesota) received 510(k) clearance from the FDA to market a lactate test for the company's IRMA SL Blood Analysis System. The IRMA system is a portable blood analyzer that performs a broad range of time-critical tests at bedside, including blood gases, electrolytes, chemistries, glucose and hematocrit in a variety of test panel configurations. In the critical care setting, lactate testing is used to detect, treat and monitor decreased tissue oxygenation, primarily associated with shock, hypovolemia and heart failure, and to monitor certain metabolic conditions.
Endocare (Irvine, California), a developer of diagnostic and treatment tools for cancer and other diseases, received 510(k) clearance from the FDA to market its Cryocare Surgical System for a minimally invasive thoracoscopic cardiac cryosurgery procedure to treat arrhythmia. The new clearance allows for a minimally invasive approach to replace, in many cases, what has historically been performed in an open surgical setting. Endocare in September 2001 formed a strategic alliance via a five-year exclusive global supply and market access agreement with CryoCath Technologies (Kirkland, Quebec), a developer of cryotherapy products to treat cardiovascular disease. The companies are developing a line of surgical probe systems to surgically treat cardiac arrhythmia in a minimally invasive manner.
Galil Medical (Yokneam, Israel) said its cryotherapy system, SeedNet Gold, received 510(k) approval for renal mass cryoablation. SeedNet Gold offers urologists a minimally invasive solution to treat prostate and renal cancers. Its ultra-thin CryoNeedles may be guided to the targeted region using imaging devices such as ultrasound or MRI, enabling the physician to visualize the freeze-zone in real-time. The SeedNet system had previously been cleared for minimally invasive treatment of prostate cancer using a template technique similar to brachytherapy, the implantation of small radioactive seeds.
The Gore Medical Products Division (Flagstaff, Arizona) of W.L. Gore & Associates introduced a self-adhesive, rapid loading version of Seamguard Staple Line Reinforcement Material at the late-January meeting of the Society for Thoracic Surgeons in Fort Lauderdale, Florida. Available in sizes to fit endoscopic linear cutting staplers, the new Seamguard material features a squeeze and load application that precludes the use of glue or any adhesive. Seamguard material was initially released in 1996 to combat prolonged air leaks during open and thoracoscopic lung surgery. It is designed to reinforce staple lines resulting from lung volume reduction, wedge resection, endo biopsy, lobectomy, bullectomy, blebectomy and pneumonectomy.
Guidant (Indianapolis, Indiana) released its next-generation Axius Vacuum 2 Stabilizers for performing off-pump coronary artery bypass surgery, also called beating-heart surgery, which allows physicians to perform bypass surgery without stopping the heart and placing the patient on a heart-lung machine. The Axius Vacuum 2 Stabilizers are designed to stabilize the area of the heart where the blocked vessel is located and to allow physicians to graft that vessel without stopping the heart. When used with the new Axius Xpose 3, the system allows the surgeon to lift the heart and access vessels in the back without compromising the natural pumping action of the heart. The company also reported the U.S. and European launch of its Flextend pacing lead. The Flextend lead allows the physician to extend or retract a corkscrew-like tip, or helix, which then attaches to the heart. It received FDA approval Feb. 7.
Guilford Pharmaceuticals (Baltimore, Maryland) filed a submission in Europe seeking an expanded indication for its cancer therapy, the Gliadel Wafer, for use during initial surgery for malignant glioma. The Gliadel Wafer is approved in 24 countries, including the U.S., for use during recurrent surgery for glioblastoma multiforme (GBM), a rapidly fatal form of malignant brain cancer, and in Canada for use in both primary and recurrent surgery for GBM. A biodegradable wafer implanted at the time of surgery, it delivers chemotherapy directly to the tumor site, minimizing drug exposure to other areas of the body. The European regulatory submission is based on results from a randomized, double-blind, placebo-controlled Phase III trial, which demonstrated a 30% improvement in survival rates in patients who received Gliadel Wafer therapy at the time of their initial diagnosis and surgery for malignant glioma.
Hemosol (Toronto, Ontario) received FDA notice to begin a clinical trial of its lead oxygen therapeutic, Hemolink (hemoglobin raffimer), in re-do cardiac bypass grafting (CABG) surgery. The two-armed study will investigate the efficacy of Hemolink in approximately 140 patients at more than 40 U.S. sites. All patients will undergo the same intraoperative autologous donation procedure, with either Hemolink or allogeneic red blood cells administered in response to transfusion triggers. The re-do study design is similar to an ongoing primary CABG study, which received FDA approval in November 2001 and is now actively recruiting patients; both studies are expected to run concurrently and conclude in 2Q02. Data from the primary and re-do studies will be used to strengthen a pending application in the UK.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) said the FDA has accepted all four modules of its premarket approval application for the CTLM beast-imaging system to be used as an adjunct to mammography. The company also said the U.S. Patent and Trademark Office awarded U.S. Patent No. 6,339,216 titled, "Time-Resolved Breast Imaging Device." The patent protects the key electronics of a time-resolved optical CT scanner. The company said it addresses the solution to the problem of simultaneously accommodating a large dynamic range of light intensities emitted from the breast while achieving the necessary temporal resolution.
Imagyn Medical Technologies (Irvine, California) received a Notice of Allowance from the U.S. Patent and Trademark Office in a pending patent application covering aspects of its robotic laser welding device for the production of isostar Iodine-125 brachytherapy seeds. Imagyn markets a line of seeds for treating prostate cancer, including isostar Iodine-125 and TheraSeed Palladium-103 seeds. After receiving 510(k) clearance, the company is marketing its isosleeve product, a sterilized, custom-loaded needle delivery system for prostate brachytherapy that is shipped to the customer ready for implantation.
International Remote Imaging Systems (IRIS; Chatsworth, California), a manufacturer of urinalysis workstations, received 510(k) clearance from the FDA for the Aution Max AX-4280 Automated Urine Analyzer. This instrument is the first of several new products expected to be launched by the IRIS Diagnostics Division in 2002. The company said the AX-4280 is the world's smallest, fully automated walk away urine chemistry strip reader designed around a universal sample transfer rack system that provides automatic, unattended batch processing of up to 210 samples at a throughput of 225 samples per hour. The analyzer performs 12 tests on urine, including nine chemistries, specific gravity by refractometer, color and clarity.
Interpore Cross International (Irvine, California) received 510(k) clearance from the FDA to market a rectangular configuration of its patented GEO Structure spinal implant. This is the second configuration of the GEO Structure to receive clearance. The first configuration, an oval, received clearance last August. The GEO Structure can be used in a variety of applications in the lumbar and thoracic regions of the spine. The device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column for a prolonged period even in the absence of fusion. The cast titanium geometric structure provides high strength while allowing over 90% void space for placement of a graft material. The GEO Structure will be released on a limited basis this quarter, with a national launch beginning in mid-year.
Iomed (Salt Lake City, Utah) is terminating its collaboration with Santen Pharmaceuticals (Osaka, Japan) despite studies showing that Iomed's non-invasive ophthalmic drug delivery OcuPhor System was able to deliver an anti-angiogenic drug to the retina and choroid in quantities that are within a therapeutic range. Santen and Iomed agreed that they would not proceed with joint development of a novel treatment for age-related macular degeneration using the drug in combination with OcuPhor. While the studies demonstrated that the drug, when delivered via subconjunctival injection, achieved the desired anti-angiogenic effect in an animal model, in Santen's opinion, the therapeutic index was too low for the drug to be considered for further development.
Karl Storz Endoscopy-America (Culver City, California) launched its 2mm Hopkins rod lens hysteroscope, which features brighter images and better light transmission in a smaller diameter endoscope. Fully autoclavable, the Hopkins 2mm endoscopes are available with 0 degree, 12 degree and 30 degree viewing angles. The Hopkins 2mm telescope makes it possible to perform emergency laparoscopy on trauma patients, as well as enable an optical Veress needle approach to be used in infants and pediatric patients.
LAM Pharmaceutical (Lewiston, New York) filed a 510(k) premarket notification submission with the FDA for its IPM Wound Gel wound care product, a clear, viscous, aqueous, odorless gel composed principally of sodium hyaluronate. In both human and animal trials, it has been demonstrated to be of value in the management of certain skin ulcers and wounds where maintaining a moist environment supports the healing process. IPM Wound Gel is suitable for exuding wounds such as diabetic, leg and pressure ulcers, as well as for management of wounds that are prone to bleeding.
Laserscope (San Jose, California) reported positive feedback for its Niagara laser photo-selective vaporization procedure (PVP), used for more than a year at Oakwood Annapolis Hospital (Wayne, Michigan). Used to treat benign prostatic hyperplasia, the 20-minute procedure was performed under a local anesthetic. It reduces recovery time from weeks to days, is virtually bloodless, cuts the cost of traditional invasive surgery in half, and yields almost immediate results with no sexual side effects. The procedure has been done more than 50 times since December 2000. In the procedure, laser pulses vaporize obstructive prostate tissue.
LaserSight (Winter Park, Florida) was issued U.S. Patent No. 6,334,683, titled "Eye Illumination System and Method." The patent covers a system for providing the illumination to an eye during laser refractive surgery that is needed for an eye tracking system. Eye tracking systems follow movements of the patient's eye during laser vision correction treatments, and send correcting signals to the scanning system in order to maintain the orientation and alignment of the laser beam with the visual or optical axis of the treated eye.
LumiLeds Lighting (San Jose, California), a joint venture between Agilent Technologies (Palo Alto, California) and Philips Lighting, said that FIMI Philips (Saronno, Italy) is using LumiLeds' Luxeon high-flux LED technology to improve color fidelity and extend product life for a new line of medical monitors. The Luxeon-powered backlight system in the new displays will aid in diagnosis and provide other benefits for endoscopy, ultrasound, ICU patient monitoring and other applications.
Medical Services International (Edmonton, Alberta) reported completion of independent and live testing on its VScan Hepatitis C (HCV) rapid test kit. The company said results of more than 1,000 tests show that the test is better than 99% accurate within 15 minutes. The company also completed preliminary, independent testing on its rapid diagnostic Hepatitis B Test Kit, showing that test also has accuracy greater than 99%. The kits require no additional equipment or trained personnel to complete the test.
Medical Technology & Innovations (Riviera Beach, Florida) said that the final aspects of the urinary incontinence device developed by the company show the device has the ability to control stress incontinence. It said it plans to complete the FDA application process shortly, while moving into full-scale production for world-wide distribution.
Medwave (St. Paul, Minnesota) was granted necessary approvals from Japan's Ministry of Health and Welfare for the Vasotrac APM205A Monitoring System. Nihon Kohden will distribute Vasotrac in the Japanese market. Two agreements include distribution of Vasotrac and also supply Nihon Kohden with a Vasotrac module to be incorporated into its products in the future. Recently, Medwave announced that it was granted 510(k) premarket clearance for the Vasotrac monitor in use with children; the Japanese approvals also encompass use with children. Vasotrac APM205A is designed for measuring a patient's blood pressure noninvasively on a continual basis, with updates available approximately every 15 heartbeats. It is used in anesthesiology, critical care, emergency rooms, sleep study labs and cardiology departments.
Meretek Diagnostics (Nashville, Tennessee) received 510(k) clearance for the BreathTek-UbiT breath test kit for detection of active Helicobacter pylori infection, the major cause of peptic ulcer disease. The new kit is designed for use with the UBiT-IR300 infrared spectrophotometer, which received its 510(k) clearance in December. This system enables primary care physicians to determine if a patient has an active H. pylori infection and be able to make therapeutic decisions in 26 minutes. BreathTek-UbiT's sensitivity and specificity have been established at 99% in a clinical trial using the Meretek UBT breath test as a standard and the product has been approved both as a diagnostic tool and as a test to confirm success of eradication therapy.
Micrus (Mountain View, California) reported several recent presentations on studies using the Micrus ACT MicroCoil System for cerebral aneurysm embolization. In an Oxford, England, study, 75 patients and 83 aneurysms were treated using the Micrus system. Clinicians concluded that the ACT coils conform to both spherical and irregular shaped aneurysms and were routinely used in all cases. There was no incidence of delayed re-bleeding or other clinical complications related to the use of the Micrus coils. In Buenos Aires, Argentina, a wide variety of aneurysms were treated successfully in both the anterior and posterior circulation of the brain. The Micrus product uses a heat-resistive detachment system that was demonstrated to be safe, quick, effective and reliable in treating intracranial aneurysms.
Ortec International (New York) received FDA approval to begin a pivotal clinical trial using the cryopreserved version of OrCel to treat diabetic foot ulcers. The 250-patient study is expected to be conducted at 25 U.S. centers, with patient enrollment expected to begin by mid-year. Ortec is in a pivotal trial using the cryopreserved version of OrCel to treat venous leg ulcers and has recently released data on the initial patients treated. In November, Ortec announced interim 12-week clinical data from its 40-patient pilot diabetic ulcer trial using the fresh version of OrCel. Based on those results, Ortec requested permission from the FDA to initiate a pivotal study using the cryopreserved version of OrCel.
Oticon (Somerset, New Jersey) received FDA clearance for Adapto, a voice-activated hearing aid that gives priority to human voice over other sounds in the environment. Similar to the technology used in voice-activated telephones and computer software, Adapto uses a miniature computer chip feature called VoiceFinder that detects speech signals in the environment and immediately processes these signals for better understanding. When no speech is detected, the 100% digital hearing aid automatically turns down the volume by changing to a more comfortable, relaxing, listening mode. Adapto switches from comfort mode to speech mode in a fraction of a second when someone starts talking.
Palomar Medical Technologies (Burlington, Massachusetts) received FDA clearance to market its EsteLux Light-Based System for pigmented lesion treatments. Last year, the system was cleared for hair removal. The company said it works on age-spots, sunspots and other common skin discolorations. EsteLux's flashlamp technology features a high pulse rate and a large spot size that increases effectiveness when treating large areas such as legs and backs.
Paradigm Medical Industries (Salt Lake City, Utah) submitted a supplementary 510(k) application to the FDA requesting additional applications for its Ocular Blood Flow Analyzer, expanding its uses into other sectors of the eye-care discipline, as well as other medical sub-specialties, including cardiology. Additional indications submitted include: measuring, displaying and reporting the volume of blood entering and exiting within a specific region of the body; estimating, displaying and reporting intraocular pressure; estimating, displaying and reporting pulsations over time as a means in aiding in the diagnosis of carotid artery insufficiency; showing and reporting ocular blood flow with systolic and diastolic measurements for use with the electrocardiograph and tracking progress of pre- and post-cardiovascular surgery with blood flow analysis.
PerkinElmer Life Sciences (Boston, Massachusetts) reported two new products for sample preparation and liquid handling. The Evolution P3 precision pipetting platform is a new, benchtop system for dispensing into 96-, 384-, and 1,536-well microplates. The FlexDrop precision reagent dispenser is a standalone platform for assay development. Evolution P3 provides high-throughput automation for a wide range of applications, including compound plate reformatting and replication, cell-based and ELISA assays, reagent additions, PCR setup and more. The FlexDrop precision reagent dispenser provides a broad range of standalone dispensing capability. The system can dispense up to four reagents into 96- to 1536-well SBS standard shallow or deepwell microplates with a dynamic dispense range of 500nL to 2.5mL and above for plate preparation, assay development and compound archiving.
PharmaSonics (Sunnyvale, California) completed enrollment for its pivotal SWING and Euro-SPAH Intravascular Sonotherapy trials. Enrollment began in November 2000 and reached a goal of 800 SWING patients and 400 Euro-SPAH patients. Euro-SPAH results will be presented in September at the Transcatheter Cardiovascular Therapeutics symposium and the European Society of Cardiology congress. The SWING results and the combined SWING/ Euro-SPAH results will be presented in November at the American Heart Association meeting. The trials are designed to establish the long-term safety and efficacy of the intravascular sonotherapy procedure to reduce the incidence of restenosis in patients with de novo stents in native coronary arteries. Euro-SPAH is the pivotal trial for Europe. SWING is one of two U.S. pivotal trials, along with the ongoing SPLASH trial, designed to establish the long-term safety and efficacy of sonotherapy to reduce the incidence of restenosis in patients treated for coronary in-stent restenosis.
Pi-ray America (Torrance, California) is marketing Pi-ray fabric, with features that include antimicrobial, antiflammability and deodorant effects, in the U.S. Bio-Path Clinical Laboratories (Van Nuys, California) conducted antimicrobial studies on the pi-ray fabric. After 24 and 48 hours inoculation at 37 degrees C, the test plate showed complete inhibition of bacterial growth under and adjacent to the pi-ray fabric. On the other hand, the control plate showed unrestricted growth of methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeroginosa on the agar under, adjacent and directly in contact with the control fabric. The company said the use of pi-ray fabric in medical facilities such as linens, blankets, pillowcases, uniforms and gowns could reduce incidence of cross-contamination and nosocomial infections.
Rheologics (Exton, Pennsylvania) concluded the preliminary clinical trial of one of the first research studies to use its Kensey Rheolog device. HELP (Heparin-induced Extracorporeal LDL-Precipitation), or LDL-Apheresis, is a process that reduces serum LDL-cholesterol by 65% in two hours for patients with a level greater than 200mg/dl and cardiovascular disease resistant to pharimcotherapy. The study was performed to evaluate the blood viscosity levels of high cholesterol patients during intervention treatment. It measures blood viscosity by enabling healthcare providers and researchers to test circulating, unadulterated blood.
Repro-Med Systems (Chester, New York) said the Full Stop Protection for its Res-Q-Vac Airway Suction System is in production and was expected to be distributed by mid-February. Full Stop Protection prevents any overflow and protects health care providers from all liquid or airborne potentially infectious materials. Its design is the subject of a patent application. The Res-Q-Vac is a hand-held, portable medical suction instrument used for patients who require resuscitation such as heart attack victims, unconscious patients or anyone exposed to chemical warfare agents.
RITA Medical Systems (Mountain View, California) said the European Patent Office determined that RITA is entitled to a European patent (EP 0 777 445) covering radiofrequency ablation technology. The office approved 27 claims, despite the opposition proceeding brought by RadioTherapeutics (Sunnyvale, California), which had sought to invalidate the patent. RITA develops products for patients with solid cancerous or benign tumors. The RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death.
Rubicon Medical (Salt Lake City, Utah) completed the feasibility testing of its Embolic Filter, a device under development for protection against embolic events in coronary and peripheral stent procedures. The Rubicon Filter is used to protect vital organs during stent procedures, in which some of the plaque material that clings to the walls of the arteries can become dislodged. The Rubicon Filter acts as a tool, downstream from where a stent is placed, to capture this embolic material and to remove it from the bloodstream.
Science & Technology International (STI; Honolulu, Hawaii) completed cervical cancer trials in Vilnius, Lithuania, using its HyperSpectral Diagnostic Imaging system, an instrument it bills as noninvasive, non-contact and a pain-free approach to diagnosis. STI's instrument is placed about eight inches away from the cervix, which is scanned in one pass. Many color bands are collected, creating a large hyperspectral cube of data. Within seconds that image is displayed on a screen similar to a laptop computer, and its software processes the information. The six-week trial screened 111 women. Previous FDA trials at Tripler Army Medical Center in Hawaii and the Walter Reed Army Medical Center in Washington screened nearly 200 women with abnormal Pap smear results. STI was awarded a multi-million-dollar federal contract to conduct Phase II of the FDA trials. Phase III is scheduled to begin the latter part of 2002.
SenoRx (Aliso Viejo, California) received 510(k) clearance from the FDA to market its SenoCor breast biopsy device for the diagnosis of breast cancer. The SenoCor device uses the company's core SenoPulse radiofrequency technology. The company hopes to establish SenoCor as the preferred modality for percutaneous diagnosis of certain breast cancer lesions under ultrasound imaging.
Serono (Rockland, Massachusetts) reported the U.S. launch of SeroJet, a needle-free option for delivering Serostim [somatropin (rDNA origin) for injection], the company's recombinant human growth hormone. Serono said it provides the only needle-free delivery system for growth hormone in the U.S. SeroJet eliminates the risk of accidental needle-stick injuries, and is being offered at no additional cost to Serostim patients. Using a coiled spring mechanism, SeroJet delivers a finely dispersed, high-pressure stream of Serostim through a point of entry in the skin that is five times smaller in area than that of a standard 28-gauge needle injection.
Siemens Medical Solutions (Iselin, New Jersey) received FDA clearance for its Magnetom Trio-3T whole-body MR scanner. The whole-body concept of the Trio incorporates a full-sized patient bore, which permits the study of all human anatomy on any patient. The scanner will be used to study small vascular pathologies, musculoskeletal diseases and tumors in cases where early detection can greatly improve patient outcomes. The company also expects the Magnetom Trio to have an impact on cardiac applications. Equipped with Siemens' syngo common user interface, the Trio is compatible with other MR systems, other diagnostic modalities and hospital information systems, giving health care professionals comprehensive background and details of a patient's condition.
Smith & Nephew (Memphis, Tennessee) received approval from the Therapeutic Goods Administration to begin selling Supartz in Australia. The Supartz product is designed to aid osteoarthritis pain of the knee. Supartz is manufactured by Seikagaku Corp. of Japan, which operates in the field of glycoscience, as well as in research and development of complex carbohydrates for medicines, pharmaceutical ingredients, reagents and diagnostics. The company also released a patient registry database designed to track and evaluate patient responses to Supartz joint fluid therapy.
Snomed (Northfield, Illinois) released its Clinical Terms First Release, a comprehensive international and multilingual clinical reference source. The terminology delivers to the entire health care community uniformity for medical communications that spans languages, clinical specialties and geographic borders. CT First Release allows for the capture, sharing and analysis of health data worldwide, making health care information accessible and usable, whenever and wherever it is needed. CT First Release serves as the common index against which data is encoded, stored and referenced.
SpectRx (Norcross, Georgia) received FDA clearance to market a minimally invasive insulin infusion patch set for use with insulin pumps. Designed for use with all makes of insulin pumps, it delivers insulin through five microneedles that are less than half the length of ordinary insulin pump infusion needles. Reduced penetration is designed to improve comfort and wearability. In addition to the insulin patch infusion set, SpectRx has received FDA clearance for soft catheter insulin pump infusion sets, an insulin pump reservoir and a multi-purpose insulin pen. The first of these products, the Simple Choice Soft and Simple Choice Quick insulin pump infusion sets, are expected to launch by the third quarter of this year.
St. Jude Medical (St. Paul, Minnesota) launched the Angio-Seal STS Platform, its latest-generation vascular closure device. Offered in both 6 Fr and 8 Fr configurations, it is indicated for use in closing the femoral arterial puncture sites following diagnostic or interventional catheterization procedures. The STS Platform features a self-tightening suture, which eliminates the need for the post-placement spring used in previous Angio-Seal models. This feature allows the arterial closure procedure to be completed in the catheterization. The product also integrates Secure-Cap, which facilitates proper deployment through both tactile and audible confirmation during the closure process. The STS Platform incorporates additional visual markers to provide positive confirmation of a proper anchor-arteriotomy-collagen sandwich.
Stryker (Kalamazoo, Michigan) received approval to market its OP-1 Implant (Osteogenic Protein 1) in Canada for the clinical indication of long bone nonunions. Commercial shipments are expected to begin in the second quarter.
Texas Biotechnology (Houston, Texas) said at the 27th International Stroke Conference in San Antonio, Texas, that clinical investigators for the company presented a retrospective analysis suggesting positive clinical effects for Argatroban in acute ischemic stroke in patients with heparin-induced thrombocytopenia (HIT). Argatroban, a direct thrombin inhibitor anticoagulant, was approved in November 2000 by the FDA as an anticoagulant therapy for the prophylaxis or treatment of thrombosis in patients with HIT.
Thermo Biostar (Boulder, Colorado), a Thermo Electron business, introduced the Acceava hCG Combo rapid immunoassay for the detection of pregnancy. The Acceava hCG Combo test is approved for use with serum in moderately complex laboratories and with urine in waived laboratories. Comparative studies have shown the Acceava hCG Combo test to be more sensitive than other rapid urine/serum pregnancy tests. The product results in a seven-minute procedure, has a long shelf life and is cost effective.
TomoTherapy (Middleton, Wisconsin) received FDA 510(k) approval to market its helical tomotherapy system. The HI-ART System is designed to deliver radiation therapy to cancer patients. It provides treatment planning, positioning images and helical radiation delivery into one system, helping improve the precise delivery of radiation to a tumor, while reducing the delivery of radiation to vital healthy tissues. TomoTherapy said it anticipates that the system will be available for delivery later this year.
Viasys Healthcare (Yorba Linda, California) said it will market and distribute HealtheTech's (Golden, Colorado) MedGem, a hand-held indirect calorimeter, to hospital and related markets. The MedGem device recently received FDA clearance for use in clinical and research applications. The device measures respiratory airflow and oxygen uptake and determines resting metabolic rate, the number of calories a person burns per day at rest.
WorldHeart (Ottawa, Ontario) said the FDA approved its request to add 15 subjects to a clinical trial of its artificial heart pump as a long-term therapy. The company is investigating whether its Novacor left-ventricular assist device can provide a long-term option for patients with end-stage heart failure who are too sick to qualify for a heart transplant. The devices work by taking over the pumping function of the heart's left ventricle. The extended approval will increase WorldHeart's trial enrollment to 55 patients. The approval follows an October FDA approval to add 15 patients to the trial, which began in March 2000. WorldHeart's trial compares survival rates and quality of life between end-stage heart failure patients who receive the Novacor heart pump and those supported by available drug therapies. Novacor is commercially available as a bridge to transplantation in the U.S., Canada, Europe, and parts of Japan and China.