A cochlear implant/processor combination to improve the hearing of severe to profoundly deaf adults, and profoundly deaf children who are very young, has been approved for commercialization by the FDA. The Nucleus 24 Channel Cochlear Implant, produced by Cochlear Corp. (Denver, Colorado), is an implant/processor combination one-third the size of other implants, enabling implantation in children as young as 18 months. Cochlear characterized the device as the "first true advance in cochlear implant technology in more than a decade, and one that com-bines the most sophisticated technology with the sim-plest, most cosmetically discreet external device avail-able." The implant is used in conjunction with the company's multi-channel ESPrit Ear Level Speech processor, about the size of a hearing aid worn behind the ear, and weighing less than half an ounce. Besides its small size, the Nucleus 24 offers a maximum num-ber of stimulation electrodes to enhance the user's chance of hearing sounds and interpreting speech. Cochlear estimates the potential market for the device to be about 200,000 adults and children cate-gorized as profoundly deaf. The cost of the devices and the implanting procedure will range from $30,000 to $50,000, according to a spokesperson for the com-pany. The Nucleus 24 takes cochlear implant technol-ogy "into the next century," said President and CEO Ronald West. "By optimizing the capabilities of the internal device and miniaturizing the external speech processor without sacrificing performance, we have developed the ultimate cochlear implant system. In doing this, we have expanded our base of potential candidates for the device, to those cochlear implant candidates who have delayed their decision due to their aversion to wearing the body-worn speech processor. Now, wearing a cochlear implant is as sim-ple as wearing a hearing aid." West noted also the particular advantages for those who receive the device at an early age. "We know from years of research that the earlier children are implanted, the more likely they are to develop speech and hearing at a rate more like that of their hearing peers," he said. Results of clinical trials have shown that the implanted device and processor pro-vide increased confidence "in school, sports, work and social situations," according to Noel Cohen, MD, professor and chairman of the Department of Oto-laryngology, New York University Medical Center (New York), one of the more than 30 medical centers that conducted product trials. The device has been approved outside the U.S. for more than a year and has been implanted in more than 2,000 individuals. The company is hoping to gain regulatory approval for the device in Japan sometime in 1998. Elsewhere in the product pipeline: * ArthroCare (Sunnyvale, California) has intro-duced three new wands expanding the company's line of instruments for removing or shrinking tissue during arthroscopic joint surgery. The CoVac wand adds suction to the existing functions of tissue removal and hemostasis, reducing loose or free-float-ing tissue. The Saber features a single, curved elec-trode that removes tissue along the full length of the electrode, not just at the tip. And the Eliminator has a broad, brush-like design and larger electrode surface for rapid tissue removal and enhanced coagulation. * Biolase (San Clemente, California) has received FDA 510(k) clearance to begin marketing of the Skin-Laser System, recently acquired from Laser Skin Toner (St. Louis, Missouri) in a stock deal. The Skin-Laser focuses laser energy to the underlayer of dermis to create skin tightening without significant damage, burning, or surface cuts. The system will become part of Biolase's Aesthetic Division, which includes the company's DermaLase, HydroKinetic System and Lazer ToothBrush products. * Bio-Plexus (Vernon, Connecticut) has received a patent for its Drop-It needle holder, designed for one-handed disposal of blood-collection needles by health care workers. It features push-button quick release and can be used with up to 100 Punctur-Guard or conventional needles. It automatically releases the needle when used with the Drop-It Needle Disposal Container. * Cardiac Science (Irvine, California) has received ISO 9002 certification and has met the European Union's Medical Devices Directive (MDD) require-ments for its products to be sold in Europe. Cardiac Science is the developer of the Powerheart Automat-ic External Cardioverter Defibrillator technology, a bedside defibrillator used to monitor hospitalized cardiac patients for life-threatening heart rhythms, delivering defibrillation shock without human inter-vention should a patient suffer cardiac arrest. * Cardima (Fremont, California) has received FDA approval for its Vueport balloon occlusion guid-ing catheter, a balloon catheter with a compliant bal-loon on its distal tip designed to allow access and enhance visualization of the coronary venous system for mapping of ventricular tachycardia. The device is designed to temporarily occlude the coronary sinus, which is the main draining blood vessel in the heart, allowing the physician to inject radiopaque dye which shows the vasculature of the heart during X-ray. Additionally, the company received 510(k) clear-ance for its minimally invasive Pathfinder Mini microcatheter for diagnosing ventricular tachycardia, a condition affecting an estimated 1 million people in the U.S. and the most common causes of sudden car-diac death. The device is the smallest available micro-catheter for VT diagnosis, thereby enabling the physi-cian to access areas of the heart currently inaccessible by traditional catheter technology. It is the size of a coronary guide wire and uses Cardima's technology to diagnose signals from within the heart wall rather than from within the heart chambers. * Computer Motion (Santa Barbara, California), a developer of robotic and computerized surgical sys-tems, has received FDA approval to market its voice-controlled laparoscopic insufflator, a device used to create operating space necessary to perform minimal-ly invasive surgery. The insufflator is the sixth voice-controlled device designed to work with the compa-ny's Hermes OR Control Center. * CryoLife (Marietta, Georgia) has been awarded the European CE mark for its CryoLife-Ross porcine heart valves, allowing unrestricted distribution in European markets. The valve is designed for use in car-diac reconstruction surgeries in children. The product line features a series of heart valve replacements appropriate to various stages in the growth cycle of infants and young children as they mature and out-grow implanted valves, thereby fulfilling a critical shortage in infant tissue heart valves. The product augments the company's CryoLife-O'Brien porcine valve line and the CE mark for both valves will be used to support FDA applications for approval. * Endocare (Irvine, California) has received FDA approval of its investigational device exemption appli-cation to initiate human clinical studies of the Horizon Temporary Stent for the relief of acute urinary reten-tion. The device provides temporary relief of bladder outlet obstructions in those suffering benign prostatic hyperplasia. Made of nitinol, the device features shape memory designed for quick and easy introduction and removal through a minimally invasive procedure. After placement, the device expands to open the pro-static urethra, providing up to 30 days of relief. With the approval, multi-site clinical studies are scheduled to begin by the end of summer. * Equidyne Systems, a subsidiary of American Electromedics (San Diego, California), has received two U.S. patents for its Injex needle-free medication injection technology. The system delivers medication painlessly through the skin without a needle. The product delivers a wide variety of physician- and self-administered medications, including insulin, vac-cines, anesthetics, inoculates, protein-based recombi-nants and other drugs. The Injex system has received FDA 510(k) marketing clearance. * FemRx (Sunnyvale, California) has received FDA510(k) clearance from the FDA to market its Mae-stro Fluid Management System, which integrates with the Flo-State Fluid Management System to provide simplicity and control in managing minimally-inva-sive surgical procedures inside the uterus. Features of the Maestro allow surgeons to choose a desired intra-uterine pressure to ensure a clear surgical field. * Hygeia Biomedical Research (HBR; Monsey, New York) has developed a prototype of the LOM 33 and LOM 34 labor monitors to determine the differ-ence between true or false labor. Determination of pre-mature labor with the LOM 33 will signal the need for administration of drugs to stop contractions. The LOM 34 will signal to the patient the onset of premature labor. Both devices are designed for use with HBR's proprietary electrode interfaces. The company has received U.S. and international patents covering the technology underlying the LOM and related products. * Iomed (Salt Lake City, Utah) has released its newest generation of iontophoretic dose controller, the Numby 900. Using a push-button operation, the con-troller delivers fast and effective local dermal anesthe-sia when used in conjunction with Iomed's Numby Stuff electrodes and Iontocaine(a) anesthesia medica-tion. The Numby 900 is part of Iomed's needle-free method of delivering medications into and through the skin using a low-level electrical current from a small battery-operated, dose-controlling unit. Numby Stuff is used in pediatric applications to numb an area of the skin prior to painful local procedures. * Johnson & Johnson Medical (J&JM; Tampa, Florida) has received FDA clearance to market the Protectiv Acuvance I.V. Safety Catheter that reduces the risk of accidental needlesticks. The catheter incor-porates an internal needle blunting system, which provides an improved level of safety while maintain-ing flexibility of use. It employs Punctur-Guard tech-nology developed by Bio-Plexus (Vernon, Connecti-cut), in conjunction with J&JM. * MD Systems (Westerville, Ohio) has received FDA clearance to market its CardioGrip device, a hand-held exercise instrument offering an alternative to drug management of cardiovascular fitness. The device features a microprocessor-guided isometric exercise protocol, the power provided by a portable lightweight battery. The FDA clearance allows prod-uct marketing "for adjunctive use in the overall man-agement of cardiovascular fitness." The company is carrying out additional trials for more specific indica-tions, including a pilot study at the Cleveland Clinic. * Micro Therapeutics (San Clemente, California) has received FDA approval to market its Easy Rider micro-catheter for neurovascular applications. The instrument is used over a guide wire and facilitates catheter positioning in the small, remote blood vessels of the brain. The device also has been approved for sale in Australia. * North American Scientific (North Hollywood, California) has received FDA approval to market its Palladium-103, a brachytherapy source for treating prostate cancer and other malignancies. Compared to surgical radical prostatectomy, Palladium-103 has been shown to produce a significantly lower incidence of side effects such as impotence and incontinence. The company expects product availability by year-end. * Oakfield Instruments (Witney, United King-dom) has developed Flexisoft IIIv2 gastrointestinal motility software to be compatible with the Flexilog range of recording devices. The software program provides full stationary manometry capability, including vector volume studies, ambulatory pres-sure and pressure plus pH analysis. * OEC Medical Systems (Salt Lake City, Utah) has released data demonstrating that images from its new portable cardiac imager were comparable to images obtained from a fixed room cardiac cath lab. The clinical results were released at the recent Inter-national Society of Minimally Invasive Cardiac Surgery meeting in Minneapolis. Researchers found "no differences in image quality" and that the portable system maintained higher sensitivity "for detecting a perfect anastomosis." OEC Medical is a leading worldwide manufacturer and marketer of fluoroscop-ic imaging systems for intraoperative applications. * Paradigm Medical Industries (Salt Lake City, Utah) has received FDA approval for its QuietTip and PhacoPak cataract surgery products. The devices are sold as accessories to Paradigm's ultrasound and laser cataract surgery equipment. * Photoelectron (Lexington, Massachusetts) said its Photon Radiosurgery System was used to administer adjunctive radiation treatment on a human subject in the U.K., marking the launch of its proprietary breast tumor X-ray trial in that country. * Point of Care Technologies (Rockville, Mary-land) has received FDA 510(k) clearance to market its Genie Cup six-drug panel which tests for the presence of six illegal drugs in urine. The Genie Cup integrates sample collection, testing, transportation and storage in a one-step device. After collection of a sample, the donor seals the Genie Cup and turns its cap, transfer-ring a portion of the sample into an isolated testing chamber without operator intervention. The segregat-ed sample is uncontaminated and available for fur-ther testing, transportation or storage. The company said it will begin shipments immediately. * Radionics Software Applications (Burlington, Massachusetts) has received FDA 510(k) clearance to market the Universal Instrument Registration and Microscope modules of its Optical Tracking System used for image-guided surgical procedures. The Optical Tracking System provides a surgical navigation solution for cranial and spinal procedures, matching a patient to his or her preoperative image scans and enabling the surgeon to track various instruments in and around the patient anatomy. The instrument location, both tip and trajectory, is then displayed in numerous interactive 2-D and 3-D views. The company said it has received 11 FDA clearances for products since June of last year. * Rhythm Technologies (Jacksonville, Florida) has released in Europe the Rhythm Catheter, the first disposable electrophysiology catheter for the delivery of internal cardioversion and defibrillation therapy for treating atrial and ventricular tachyarrhythmias. Additionally the company received investigational device exemption approval from the FDA for a 10-center clinical trial of the device. To date, 30 patients have been treated. The company said it will file a premarket approval submission for the device later this year. * Rochester Medical (Stewartsville, Minnesota) has introduced its Release-NFTM Catheter, which uses a controlled-release process of drug delivery to prevent hospital-acquired urinary tract infections. The catheter is a latex-free silicone Foley catheter incorporating into its tubing the anti-bacterial agent nitrofurazone, a broad-spectrum antimocrobial drug. The tubing releases the drug into the urinary tract in a sustained-release method to protect urethral tissues from infection. * Select-Sutter Medizintechnik (Freiburg, Ger-many) has produced a bipolar unit for cauterization of the nasal concha as a treatment for nasal hyperpla-sia. The bipolar needle process can be carried out under local anesthesia without pre-medication. * Somnus Medical (Sunnyvale, California) has received six additional U.S. patents related to its Somnoplasty system, covering methods and devices for treating obstructions that block a person's upper airway and result in habitual snoring and chronic nasal obstruction. The new patents add to 12 patents already held by Somnus, which said it has 36 other patents pending on its technology. * SpectraScience (Minneapolis, Minnesota) has received a U.S. patent for its Optical Biopsy Forcep, a part of the company's Optical Biopsy Systems. The device is designed to collect tissue samples using min-imally invasive endoscopic techniques for histo-pathological examinations. Applications are for endo-scopic gastrointestinal and urological biopsy applica-tions and features include an optical fiber for the trans-mission of light during biopsy procedure.
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