The FDA has approved a new type of hearing device, the Vibrant Soundbridge, made by Symphonix Devices (San Jose, California), with the agency calling it the first implantable hearing device approved in the U.S. to treat moderate to severe sensorineural hearing loss. Symphonix believes that the Soundbridge has the potential to replace hearing aids in a large percentage of the hearing-impaired population. The device is implanted behind the ear in the temporal bone, or skull, a wire leading down to a small electromagnet – termed a floating mass transducer – that is attached to the middle ear bone. Sound is converted to mechanical energy and is then transferred directly to the middle ear. In contrast, regular hearing aids are placed in the inner ear and simply magnify sound. Implanting the device takes about one-and-a-half to two hours and can be performed on an outpatient basis. Procedure cost will range from $15,000 to $20,000.
According to the FDA, the device does have some risks, including problems associated with the surgery. In clinical trials, 2% of patients reported that their hearing became worse, and 5% had long-term ear pain. Another 2% said they had permanently altered taste, and 16% of the patients complained of a permanent fullness in the ear. Symphonix is conducting an 18-month follow-up study to evaluate the long-term safety and effectiveness of the implant, the FDA said. Other companies are attempting to develop similar technology, but the company said none has progressed beyond Phase I trials.
Two other firms that are working on comparable technology include Implex (Ismaning, Germany) and Otologics (Boulder, Colorado). The market potential for such devices is substantial, since hearing loss affects almost 28 million people in the U.S. alone, according to Symphonix, with the vast majority of them suffering from sensorineural hearing loss, the result of hair cells, or nerves in the inner ear, being damaged. The Vibrant Soundbridge received CE mark approval in March of 1998, and the company was able to bypass Phase II trials in the U.S. based on data collected from its European sites. So far, close to 400 implantations have been performed worldwide. Symphonix was founded in 1994 and went public in early 1998. Its approximate capitalization is around $100 million.
Elsewhere in the product pipeline:
Advanced Sterilization Products (ASP; Irvine, California), a Johnson & Johnson company, has launched the STERRAD 100S Sterilization System, its next-generation, low-temperature, hydrogen peroxide, gas plasma sterilizer for processing medical devices and instruments. The system, which provides 55-minute processing time and enhanced cycle performance, received FDA clearance in June and is based on the STERRAD 100 System, used in the U.S. since 1993. The STERRAD system uses a patented process involving the generation of low-temperature gas plasma from hydrogen peroxide.
CardioTech International (Woburn, Massachusetts) has developed an infection-resistant polyurethane coating based on research involving three disciplines: polymer chemistry, textile chemistry and biomedical science. According to the company, some 50,000 to 100,000 vascular catheters become infected each year in the U.S., with resulting costs estimated at more than $300 million. The research employs textile technology to incorporate broad-spectrum antibiotics into a polyurethane coating without the use of binders, resulting in long-term antimicrobial activity. The research was sponsored by a Phase I Small Business Technology Transfer grant from the National Institutes of Health (Bethesda, Maryland), and the results will be presented at a seminar, "Advances in Medical-Grade Polyurethanes," scheduled for Nov. 13-15 in Somerville, Massachusetts. CardioTech says it now has the ability to produce devices, such as vascular access grafts and indwelling catheters that are inherently infection-resistant over extended periods. The coating, based on ciprofloxacin hydrochloride, may be used in both Dacron and ePTFE-based vascular grafts to help prevent infections.
Careside (Culver City, California) received FDA market clearance for its Hemoglobin and Hematocrit blood tests on the Careside Analyzer. According to the company, the tests are the most commonly performed hematology tests due to the importance of hemoglobin and hematocrit in the assessment of general health. The hemoglobin test gives a quantitative measure of the hemoglobin concentration in an anti-coagulated whole blood sample. The hematocrit result is calculated from the hemoglobin result, providing a cost-effective and efficient means of measuring blood chemistry, electrochemistry and coagulation function at the patient's point of care, according to the company. The instrument enables health care practitioners to obtain blood test results and report them within 15 minutes of drawing a blood sample. Careside markets a blood testing system combining its Careside Analyzer and a companion hematology system called the H-2000 Hematology Analyzer with its Careside Connect record management system linking the two devices.
Cellomics (Pittsburgh, Pennsylvania) has received U.S. patent No. 6,103,479, titled "Miniaturized Cell Array Methods and Apparatus for Cell-Based Screening." The claims encompass methods for producing a cassette containing a micro-patterned chemical array to which cells are bound and a chamber that provides a fluid delivery system for delivering reagents to the cells on the substrate. The patent claims relate to key elements of the company's CellChip program. Cellomics' products use fluorescence-based reagents in automated platforms and cellular informatics to speed the drug discovery process.
Cyber-Care (Boynton Beach, Florida) has received FDA 510(k) clearance for its Electronic HouseCall system, an Internet-based technology that remotely monitors individuals in their homes. This model has a portable form factor, self-contained wiring and the same functionality as the EHC400 patient unit, and it interfaces within the EHC network and the EHC600 provider unit. The EHC500 will be available in mid 2001. Cyber-Care is a technology-assisted health management company.
Datex-Ohmeda (Tewksbury, Massachusetts) has received 510(k) clearance from the FDA for its S/5 Network and Central, a system for tracking patient information. The system is designed to improve patient care by providing continuity of data from one bedside monitor to another, according to the company. No special data module is required for information transfer, and the S/5 Central enables clinicians to view comprehensive bedside monitor information for up to 32 patients simultaneously, using two independent screens. It allows multiple laser printers to be located anywhere on the network and provides data transfer from bed-to-bed and central-to-central.
DOBI Medical Systems (Mahwah, New Jersey), a privately-held company developing optical imaging systems, has received FDA clearance for its first information module supporting a premarket approval application for its Dynamic Optical Breast Imaging (DOBI) system. The module, submitted in April, is the first of five for the complete PMA. The DOBI System is to be used as a secondary screening device, similar in use to ultrasound to non-invasively differentiate benign from malignant lesions. The system detects the effect of an increase in angiogenesis associated with the growth of malignant lesions. The company says that the DOBI provides a digital, noninvasive, pain-free test that takes less than 10 minutes. It is currently designated as an investigational device, pending FDA approval.
Draxis Health's (Mississauga, Ontario, Canada) radiopharmaceutical subsidiary, Draximage (Kirkland, Quebec, Canada), has received FDA approval to market its Iodine-125 BrachySeed for the treatment of prostate cancer. It already has Canadian approval. The product still requires approval by the U.S. Nuclear Regulatory Commission and the Canadian Atomic Energy Control Board. The FDA has approved BrachySeed for the treatment of certain localized cancers, such as tumors of the head, neck, lung, pancreas, breast and uterus, according to the company. Draximage makes diagnostic and therapeutic products for use in nuclear medicine and oncology.
The FDA has approved the Carpentier-Edwards mitral Perimount Pericardial Bioprosthesis, a bovine pericardial tissue heart valve designed specifically for the mitral position, from Edwards Lifesciences (Irvine, California). Edwards introduced the device for U.S. aortic patients in 1991 and now adds the mitral counterpart, which the company says provides a next-generation treatment option for treating advanced mitral heart valve disease. Edwards' Perimount valve was developed by Alain Carpentier, MD, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris), working with Edwards Lifesciences bioengineers. The development involved Edwards' proprietary tissue preservation process, a wire frame stent designed using computer-aided 3-D modeling techniques, patented technology for tissue selection and integrated manufacturing processes that make the valve able to withstand the increased pressures of the mitral position. The company says that this is the only mitral pericardial valve commercially available in the U.S. Edwards develops products and services for treatment of late-stage cardiovascular disease.
Results of the second patient group of the MUSTIC trial (Multi-site Stimulation in Cardiomyopathy/Pacing in Heart Failure), presented at the 22nd congress of the European Society of Cardiology, confirm the potential of biventricular pacing as a novel resynchronization therapy in patients with severe congestive heart failure (CHF) and major intraventricular conduction delay. MUSTIC is a European multi-center trial supported by a grant and technical assistance from ELA Medical (Paris) and Medtronic (Minneapolis, Minnesota) and conducted under the auspices of the European Society of Cardiology. It was designed to evaluate the safety and clinical efficacy of biventricular resynchronization in patients with severe CHF (Class III), chronic left ventricular systolic dysfunction and wide QRS complexes (that is, greater than or equal to 150 ms for patients in sinus rhythm and greater than or equal to 200 ms for patients with atrial fibrillation), a sign of major ventricular asynchrony. Unlike previous "pacing in heart failure" studies, MUSTIC is the first single-blind randomized cross-over trial. Patients were paced on or off in both ventricles, acting as their own control, but they did not know whether they received biventricular pacing or not.
Endocare (Irvine, California) has filed for FDA 510(k) clearance to market its CryoGuide guidance system for use in conjunction with the company's CryoCare targeted cryoablation procedure for treating cancer. CryoGuide is a software-controlled ultrasound planning and mapping system designed to allow the physician to visualize the target tumor in three dimensions, facilitating more precise placement of the probes used to freeze and destroy the tumor. The company has received notice that a U.S. patent on the CryoGuide guidance system is being issued. In addition, similar integrated treatment systems are being developed for use in treating kidney, breast and liver cancer. Endocare makes cryosurgical and stent technologies for applications in oncology and urology.
Guidant (Indianapolis, Indiana) has implanted the first patient in a clinical trial to determine the safety and efficacy of renal artery stenting in hypertensive patients. Known as HERMES (HERculink Multicenter Evaluation of Renal Stenting), the study is a prospective, non-randomized trial that will enroll about 250 patients who have experienced poor results from angioplasty to treat blockages in renal arteries. This clinical study will be conducted at 25 sites throughout the U.S. Guidant's RX Herculink 14 Peripheral Stent System is the exclusive device used in this study. The system has CE mark approval and is currently approved in the U.S. and Canada for the treatment of malignant biliary duct obstructions.
Henley Healthcare (Sugar Land, Texas) has received FDA market clearance for the Sonopuls 190 Ultrasound System, the newest product to incorporate technology developed by Henley's wholly owned subsidiary, Enraf-Nonius BV (Delft, the Netherlands). The Sonopuls 190 will be marketed to clinicians for use in treating acute and chronic pain. Features include continuous and pulsed ultrasound at 1 MHz, large crystal clear parameter displays and an ergonomically shaped treatment head with permanent calibration and changeable contact control. Henley Healthcare makes products and related accessories used to control acute and chronic pain.
Meridian Medical Technologies (Columbia, Maryland) highlighted its Prime ECG electrocardiac mapping system at the annual congress of the European Society of Cardiology in Amsterdam, the Netherlands. European clinical studies with more than 4,000 patients have found that the system detects heart attacks earlier and more accurately than traditional ECG systems, according to Meridian. The system features a wireless, disposable vest with 80 screen-printed sensors rather than the standard 12 leads used in traditional ECG systems. Advanced computer software is used to process heart signals from 64 anterior and 16 posterior points about the torso, creating full-color, multi-dimensional images designed to be more revealing and easily interpreted than a traditional ECG pattern. The School of Electrical and Mechanical Engineering at the University of Ulster (Ulster, Ireland) served as the research center for developing the new technology. The Prime ECG system has received CE mark approval and is produced at Meridian's new research and manufacturing center in Belfast.
Micronics (Redmond, Washington) was issued U.S. patent No. 6,091,502, "Device and Method for Performing Spectral Measurements in Flow Cells with Spatial Resolution." The patent covers devices and methods for measuring the spectral properties of fluids flowing in microchannels and represents the first issuance in a series of patent applications developed and filed by Micronics. The method will enable the design of portable, easy-to-use medical diagnostic devices performing a variety of tests with less than a drop of blood. The technology can be used to simultaneously determine several chemical compounds in a single flow cell. This and other company technology will be used in a new generation of lab-on-a-chip-based micro-chemistry solutions and instruments, Micronics said.
Micro Therapeutics (Irvine, California) has received FDA clearance to expand its U.S. aneurysm feasibility study to three sites and 25 patients. The announcement comes following the expansion of European clinical trials to Hacettepe University (Ankara, Turkey). The current U.S. study began in December 1999 with FDA clearance to treat 10 patients using MTI's Onyx Liquid Embolic System (Onyx LES) for treating brain aneurysms. The Onyx liquid embolic material is delivered through MTI's proprietary micro catheters, directly into the aneurysm, AVM or tumor. Once inside the targeted malformation, the liquid transforms into a spongy polymer mass designed to seal off the malformation. In aneurysm treatment, such filling is intended to reduce the risk of rupture and subsequent stroke. Feasibility trials in Europe began in September 1999, and in July MTI initiated its CAMEO (Cerebral Aneurysm Multi-Center European Onyx) study with the expansion of the investigations to the site in Turkey. Two more sites, in Germany and France, are expected to initiate cases soon. To date, Onyx has been used in 45 brain aneurysm procedures worldwide. Micro Therapeutics, founded in 1993, develops, manufactures and markets minimally invasive devices for the diagnosis and treatment of vascular disease.
Mogul Enterprises (San Jose, California), a privately held company, has received FDA clearance for its 3 Fr Steerable Decapolar Electrophysiology Diagnostic Catheter. The clearance includes a fixed curve version of this catheter. Mogul Enterprises is a startup medical company that makes devices and instrumentation related to cardiovascular applications and both minimally invasive and general surgery.
Smith & Nephew (S&L; London) and its joint-venture partner, Advanced Tissue Sciences (La Jolla, California), said that statistical significance has been reached for the primary end point in the clinical trial of Dermagraft for the treatment of diabetic foot ulcers. The data demonstrated that, in difficult-to-heal chronic ulcers with a duration greater than six weeks at the time of screening, Dermagraft healed significantly more ulcers than the control treatment, the companies said. A premarket approval application has been submitted to the FDA. S&N makes medical devices and a variety of advanced tissue repair products.
St. Jude Medical (St Paul, Minnesota) has received an investigational device exemption from the FDA to begin its Post AV Node Ablation Evaluation (PAVE) clinical study. PAVE is a multicenter study evaluating treatment options for patients with chronic atrial fibrillation (AFib) who receive an "ablate and pace" procedure. These patients undergo an ablation procedure to reduce AFib and implantation of a standard right ventricular pacemaker to compensate for the resulting heart block. The PAVE study will compare the effects of biventricular or left ventricular pacing with the present standard of care of right ventricular pacing. The study will collect data on more than 600 patients in up to 65 centers worldwide. During the trial, patients will be randomized to right ventricular, left ventricular or biventricular pacing for six months. Patients who are randomized to left ventricular-based pacing also will receive a right ventricular lead to provide backup right ventricular pacing. St. Jude's Genesis system will be implanted in patients who are randomized in the PAVE study to left ventricular-based pacing. The Genesis system is a device-based ventricular resynchronization system for the treatment of heart failure available in Europe.
SonoSite (Bothell, Washington), in collaboration with its Japanese partner, Olympus Optical (Tokyo), has received clearance from the Japanese Ministry of Health and Welfare to market the SonoHeart hand-carried echocardiography system. The clearance allows Olympus to import and distribute the system to the Japanese medical marketplace. The company's SonoSite 180 system was cleared in Japan earlier this year. SonoSite makes hand-carried, all-digital ultrasound systems that it says are designed to have the image quality of larger, more expensive systems but small enough to be hand-carried in many clinical settings. Olympus Optical's Medical Products Group markets medical endoscopes, clinical analyzers and other medical equipment.
Trek Diagnostic Systems (Westlake, Ohio) launched its onSite Urine Culture Device. The company said that onSite's design provides a convenient and efficient method for detecting and enumerating specific bacteria in urine. The device is a transparent, hinged casing containing face-to-face plates of agar with a plastic sampler with two curved tips located between them. Each onSite device contains one plate of MacConkey agar, a selective medium that provides excellent differentiation between coliforms and non-lactose fermenters, and one plate of primary isolation media. Trek is a global manufacturer and distributor of automated systems and consumable products for the microbiology diagnostic laboratory.
Vasomedical (Westbury, New York) said that an analysis of data from the International Enhanced External Counterpulsation System (EECP) patient registry at the University of Pittsburgh's Graduate School of Public Health (Pittsburgh, Pennsylvania) points to a sustained improvement in angina classification, as defined by the Canadian Cardiovascular Society, at six and 12 months following EECP therapy. Before treatment, 79% of the patients were categorized as having the most severe class III or class IV anginas. Among the patients evaluated at six and 12 months post-treatment, only 16% had class III or class IV anginas. The company said the results of this analysis support the findings of a five-year follow-up study published by Lawson, et al., in the April 2000 issue of Clinical Cardiology. Vasomedical makes EECP systems based on the its proprietary technology.
Venetec International (San Diego, California) has launched the StatLock Dialysis, calling it "the first sterile catheter-securement device for dialysis patients." StatLock Dialysis replaces suture for securing central venous catheters used during renal dialysis procedures and provides stronger and safer securement for patients threatened by kidney failure. The device also protects health care workers from suture needlesticks during the suturing of dialysis catheters, by eliminating suture previously used for catheter securement. The new device is one of more than a dozen StatLock product designs which hold all kinds of medical tubes and catheters used in hospitals, skilled nursing facilities and home care settings.
Vital Images (Minneapolis, Minnesota) has received FDA 510(k) clearance for a new option to VScore, its coronary artery calcium scoring software. Called VScore with EKG Gate, this software uses an alternative measurement process that exposes Vital Images' calcium scoring technology to a much larger potential market, according to the company. Calcium is a primary component of arterial plaque, which can indicate the risk of serious coronary problems. VScore uses image data from electron beam computed tomography (CT) scanners, as well as image data from newer multi-slice helical CT scanners with coronary scanning capabilities. Vital Images makes 3-D imaging software for use in clinical diagnosis, surgical planning and screening applications.
Vital Signs (Totowa, New Jersey) has received FDA 510(k) clearance for the Breas CPAP device for obstructive sleep apnea (OSA). The clearance allows participation in the nasal CPAP market to treat OSA in the home. The company will introduce its new model, the PV10, at this month's meeting of the American Association for Respiratory Care. The PV10 is a smaller and quieter version of its predecessor, the PV100.
The Lighting Products Division of Welch Allyn (Skaneateles Falls, New York) has introduced a 50-watt metal halide fiber optic illuminator for medical and industrial endoscopy and microscope illumination. This addition to the Solarc light source family offers up to five times the optical efficiency of standard halogen light sources and three times the efficiency of xenon sources, the company said. The Solarc fiber optic illuminator consists of a 229 mm x 250 mm x 97 mm metal casing which houses a 50 watt Solarc bulb, control electronics and cooling components. The illuminator can also be customized to support any fiber or connector. It is a portable unit that can be mounted on, or in, test and inspection equipment, and it can project up to 1500 lumens of white light, featuring bulb lifetime of 2500 hours. Welch Allyn's Lighting Products Division makes lighting systems for medical, industrial and commercial lighting products.