Somanetics (Troy, Michigan) said that study results of the first intervention outcome study in cardiac surgery using information obtained from its Invos Cerebral Oximeter monitor and aortic ultrasonography reduced participants' stroke rates from 9% to 1.9%. Based on the study, the potential economic impact of this decrease for its high-risk cardiac surgery patients would be more than a 10% decrease in hospital charges – or $1.5 million total savings annually – because the hospital stay for each patient was reduced by an average of 1.2 days, according to the company. Study patients had been classified as high risk, using a risk analysis method developed at the facility. The Invos noninvasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain. It detects and transmits visible and near-infrared light through SomaSensors, single-use sensors placed on the sides of a patient's forehead. It is the only such monitor currently available for use in the U.S.
The outcome study was performed by Terence Schmahl, MD, cardiovascular surgeon at St. Luke's Medical Center (Milwaukee, Wisconsin), in conjunction with the center's statistics department. The study has been accepted for presentation at the American Society of Anesthesiologists' annual meeting in San Francisco in October, Somanetics said.
By monitoring changes in regional brain blood saturation, corrective action can be taken to reduce neurological injuries related to surgeries and other critical care situations, according to Somanetics. Intraoperative changes made during the study included increasing bypass flow rates, adjusting venous return cannula, adjusting oxygen and carbon dioxide levels and transfusing packed red blood cells.
Elsewhere in the product pipeline:
Celsion (Columbia, Maryland) has been cleared by the FDA to begin Phase II multicenter clinical trials for its Benign Prostatic Hyperplasia (BPH) treatment system. The company said the Phase II study will test the safety and efficacy of a 45-minute outpatient procedure designed to offer rapid relief to men suffering from BPH – and do so without post-treatment catherization. The company said it believes its system, if approved, would provide a simple treatment alternative to surgery for BPH. The procedure uses a patented microwave balloon catheter to deliver dual treatment modalities of heat and compression. The treatment can be performed on an outpatient basis. Celsion is focused to commercializing medical treatment systems for cancer and other diseases using focused heat technology delivered by via microwave.
Cyberonics (Houston, Texas) has received market clearance from the FDA and the European Union for the sterile version of it tunneling tool. The device is used with the company's NCP System during the implant procedure for treatment of epilepsy. Intended for single use, the Model 400S Tunneling Tool is available for shipment in the U.S. and Europe. The sterile tunneling tool replaces the Model 400 (non-sterile) tool that included a Delrin head. The stainless steel head in the enhanced device allows the tool to be provided sterile for immediate use during implant procedures, according to the company. Cyberonics makes medical devices using vagus nerve stimulation for the treatment of epilepsy and other neurological disorders.
Endologix (Irvine, California) has received FDA approval to begin a Phase II human clinical trial of its PowerLink System in treating abdominal aortic aneurysms. In addition, the company has been issued two U.S. patents for its technology, covering more than 60 claims and establishing the technology as a method of manufacturing and deploying an endoluminal graft. The company has received the CE mark for the product, which is marketed in Europe by C.R. Bard (Murray Hill, New Jersey). The Endologix ELG is a fully supported one-piece abdominal aortic device developed by endovascular surgeons at the Arizona Heart Institute. C.R. Bard has obtained an exclusive option to acquire all of the capital stock of the company before the end of the year at a pre-set price.
Guidant (Indianapolis, Indiana) has received FDA approval to market a new high-output, dual-chamber defibrillation system for patients with high defibrillation thresholds. Called the Ventak Prizm HE system, the company says that this product is the only one in the industry to provide both a size and output advantage. Patients with fast heart rhythms can experience symptoms such as palpitations, dizziness, lightheadedness, fainting or near fainting if the heart beats too fast to circulate blood effectively. The device is implanted under the skin near the collarbone to continuously monitor the patient's heart rhythm and deliver therapy when needed for patients at risk of life-threatening ventricular heart rhythms.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) reported receiving its sixth patent and that it has seven additional patents pending. Imaging Diagnostic says it has developed the CTLM, the first patented laser-based breast imaging device creating contiguous cross-sectional slice images of the breast without the use of breast compression or X-rays. The newest patent describes the variations that can be used while scanning the breast without any contact between the breast and the optical components.
InSonus Medical (Newark, California) is collaborating with Microsemi (Santa Clara, California) to develop what the companies termed the world's smallest and most inconspicuous hearing devices. The InSonus products, currently under development, will represent the industry's first extended-wear hearing technology designed to operate continuously deep in the ear canal for up to six months, according to the company. The advanced family of hearing devices will be fitted by ear, nose, and throat doctors in collaboration with affiliated audiologists. Microsemi will design and manufacture the low-power integrated circuit for the InSonus advanced hearing aid at its Micro Power Products Division (Carlsbad, California). InSonus is a venture-backed start-up company that is developing minimally invasive hearing products for the hearing-impaired. Microsemi makes analog, mixed-signal and discrete semiconductors.
Integra LifeSciences (Plainsboro, New Jersey) has commenced the launch of its Brisman-Nova, Hallin and Loftus carotid endarterectomy shunts, which join the Sundt shunt to form a line of carotid shunts. A carotid endarterectomy is a surgical procedure to prevent stroke in which a surgeon removes fatty deposits from one of the two main arteries in the neck supplying blood to the brain. Integra LifeSciences, a subsidiary of Integra LifeSciences Holdings, makes a variety of medical products and devices, concentrating on tissue regeneration technologies and products.
The FDA has cleared Lifestream's (Post Falls, Idaho) "at-home" cholesterol testing monitor with embedded Smart Card reader. The company says that this hand-held device will offer consumers a fast, inexpensive and accurate way to test themselves at home between regular doctor visits, and share the results with doctors and pharmacists over the Internet. The home cholesterol monitor measures total cholesterol from only one drop of blood placed on a test strip in the monitor, and it displays laboratory-accurate results in just three minutes. Through the Privalink system, which is integrated into all Lifestream monitors, consumers can create a private health record file through their physician, pharmacist or at home. The company says that the home cholesterol monitor will be available in 4Q00. Lifestream Technologies links secured Internet information services to its medical diagnostic products through encrypted Smart Cards to aid in the prevention, monitoring, and control of disease. The professional Cholesterol Monitor and Privalink system have been previously cleared by the FDA.
Medrad (Indianola, Pennsylvania) has introduced the Neurovascular (NV) Array, a surface coil used in magnetic resonance imaging to provide combined head and neck imaging quality which the company says is comparable to a head-only coil. This eliminates the need to change coils in mid-procedure. The NV Array's quadrature phased-array technology also permits multiple applications, including magnetic resonance angiography, standard gradient echo, fast spin echo, echoplanar and spectroscopy pulse sequences of the brain and soft tissues of the head and neck, according to the company. Medrad makes medical devices intended to enhance the clarity of medical images.
Medwave (Arden Hills, Minnesota) has received CE mark approval to sell the Vasotrac APM 205A device used to monitor blood pressure non-invasively. According to the company, it provides continual blood pressure measurement with accuracy similar to an indwelling radial artery catheter. The patient wears a sensor placed over the radial artery at the wrist and experiences minimal sensation while the measurements and waveforms are displayed on a small monitor.
Metrika (Sunnyvale, California), a developer of point-of-care diagnostics, has received FDA 510(k) marketing clearance for its Digital Response (DRx) HbA1c Patient Monitor, which the company says is the first single-use, quantitative test for long-term glucose monitoring. The device measures glucose-bound hemoglobin, or HbA1c, and is designed to perform the HbA1c test using a single drop of blood in about eight minutes. The HbA1c percentage of whole blood is shown on the monitor's digital display. Clinical labs can take up to a week to report comparable results, according to the company. Metrika makes single-use, quantitative diagnostic systems focused on the diabetes market.
NeuroMetrix (Cambridge, Massachusetts) has received CE mark approval for its NC-stat nerve conduction monitoring system. The NC-stat system is intended for diagnosis and monitoring of neuromuscular disorders of the hand and wrist, such as carpal tunnel syndrome. Available in the U.S. for about a year, the NC-stat systems consists of a hand-held monitor, a disposable biosensor and an information management system that generates what the company terms "a highly informative report." NeuroMetrix is a spin-off from the Harvard-MIT Division of Health Sciences and Technology. The company is developing noninvasive products for point-of-care testing of neuromuscular disorders.
Symphonix Devices (San Jose, California) said the Ear, Nose, and Throat Medical Devices Advisory Panel of the FDA unanimously recommended that the company's Vibrant Soundbridge be approved for use in the U.S. The Vibrant Soundbridge is a semi-implantable device designed to treat moderate to severe sensorineural hearing loss, the most common form of hearing impairment. Symphonix is awaiting final FDA approval to begin commercial operations in the U.S. Symphonix Devices is a hearing management company that makes products for individuals who cannot benefit from current hearing technology.