Guidant (Indianapolis, Indiana) launched the Acculink Carotid Stent System in Europe for the treatment of carotid artery disease. Patients may be at risk for stroke if particles of atherosclerotic plaque are dislodged from the carotid artery wall, potentially occluding vessels in the brain, preventing adequate blood flow and causing a stroke. Carotid artery stenting is a less-invasive procedure, and Guidant said Acculink is designed specifically for use in the carotid artery, featuring a self-expanding, crush-resistant stent constructed of nickel-titanium (nitinol). It is available in both tapered and straight configurations to better fit a patient's unique anatomy.

The company also reported the global launch of its second-generation Viatrac Plus Peripheral Dilation Catheter to treat peripheral vascular disease, a condition characterized by blockages in vessels within the kidneys, neck, abdomen and limbs. The product introduction follows FDA clearance and CE mark approval. In the nonsurgical procedure, a physician guides the catheter to the blockage, then inflates a balloon at the site to restore bloodflow to the area.

Guidant also said it had received CE mark approval and begun the first implants of its newest pacemaker line, the Insignia family of pacemakers. Five implants occurred on the first day of the device's availability in centers across Europe. The company said the new pacing system offers comprehensive patient management by offering 110 seconds of electrogram (EGM) storage, nearly three times the EGM storage of previous Guidant devices. EGMs give the physician a recording of the electrical activity occurring within the heart.

Elsewhere in the product pipeline:

Alliance Pharmaceutical (San Diego, California) said that its Imavist (AF0150) product will play a major part in a prostate cancer study at Thomas Jefferson University Hospital (Philadelphia, Pennsylvania). The Imavist contrast agent will be used with ultrasound imaging to improve detection. The study, which will involve 300 adult men with suspected prostate cancer, is being funded by the U.S. Department of Defense. A non-randomized trial, all patients will receive an intravenous infusion of Imavist to achieve prolonged contrast enhancement of the prostate. Transrectal ultrasound imaging pre- and post-infusion of Imavist will be compared, and all patients will undergo a sextant biopsy. Imavist is being developed jointly by Alliance and Schering AG (Germany) and is awaiting final approval from the FDA. Alliance develops therapeutic and diagnostic products intended primarily for use during acute care situations, including surgical, cardiology and respiratory applications.

American Medical Technologies (Corpus Christi, Texas) received FDA 510(k) clearance to market its new CaviLase Erbium:YAG hard tissue dental laser. The CaviLase is cleared for all classes of cavity preparations and most treatments can be done without anesthesia. It uses advanced variable pulse width technology to produce long pulses for hard tissue, and short pulses for soft tissue. This technology also allows CaviLase to have double the pulse rate of existing erbium units for smoother soft tissue cutting. Powerful handpiece illumination, common to air driven dental handpieces, is also available, a first for dental lasers. Six user-adjustable pre-sets give the dentist control of energy/pulse, pulse rate, and water and air setting. Shipments are expected to begin in November.

Bausch & Lomb (B&L; Rochester, New York) received FDA approval for U.S. marketing of its Active Eyetracking System. The eyetracker, commercially available outside the U.S. since 1994, is a high-speed image processing system that tracks movement of the eye during laser surgery. The new system will be incorporated into all B&L's Technolas 217A excimer lasers sold after this month. The Technolas 217A excimer laser with the Active Eyetracking System calculates both the speed of tracking and overall system reaction time using its active feedback scanner mechanism, prior to firing the laser pulse. Displacement of laser pulses due to eye movement during surgery can cause a variation in ablation patterns, with the potential for under-correction and induced astigmatism, according to the company. The system is the latest product in B&L's creation of an integrated system for personalized vision solutions. That technology platform will integrate information from the Zywave aberrometer (a diagnostic device that enables examination of the eye's entire optical system) and the Orbscan II (a multi-dimensional system for mapping the anterior and posterior surfaces of the cornea and measuring corneal thickness), enabling surgeons to design individually tailored treatments for their patients, according to the company.

Beckman Coulter (Fullerton, California) began shipping its Coulter LH 700 series analyzers, a new line of hematology systems that offers a combination of speed, accuracy and random-access capability to improve efficiency in high-volume diagnostics laboratories. These analyzers perform routine and emergency blood cell counts and analyses on platelets, white blood cells and red blood cells, including nucleated red blood cells that can indicate early stages of disease. The systems incorporate Beckman's AccuCount technology, which uses a combination of enhanced data collection and proprietary algorithms to help clinical laboratories deliver test results. This technology extends the upper limit of white blood count linearity from 140,000 cells/mL allowed by previous technology to 400,000 cells/mL with the LH series analyzers, and platelet linearity from 1.5 million cells/mL to 3 million cells/mL. Beckman makes instrument systems and complementary products for life science and clinical laboratories.

BioCurex (Rancho Santa Margarita, California) received Canadian approval for its flagship product, the Histo-RECAF diagnostic kit for the detection of cancers of breast, lung, stomach and the prostate as well as lymph node tissues. The RECAF receptor, on which BioCurex's technology is based, is used in detecting breast cancer and also is present in all malignant tissues studied to date, the company said. BioCurex will begin marketing the kit to a broad customer base, including medical oncologists, laboratory directors, researchers and other healthcare professionals. The company said it has initiated discussions with potential distribution partners in Canada. The company said it is seeking approvals in other strategic markets and anticipates that it will file further applications shortly. BioCurex develops technologies in the areas of cancer diagnosis, tumor imaging and therapeutics.

Bio-Rad Laboratories (Hercules, California) said that Japan's Ministry of Health, Labor and Welfare will use the company's bovine spongiform encephalopathy (BSE) tests in a large-scale screening program to begin immediately. Bio-Rad's BSE test is used to detect the disease in cattle before they are processed for human consumption. It is currently the most widely used test in Europe to diagnose mad cow disease and is considered the fastest and most sensitive method of testing available, according to the company. Since last fall, Bio-Rad has participated in the European Union's efforts to protect the public health with widespread testing. The discovery of a confirmed case of mad cow disease in Japan is the first in Asia and has generated concern that the disease may be more widespread than originally thought. Mad cow disease has been linked to Creutzfeldt-Jacob disease (vCJD) in humans, a degenerative and fatal disease of the brain, and deaths from vCJD have been on the rise recently in Britain. Bio-Rad is a manufacturer of life science research products and clinical diagnostics.

Caliper Technologies (Mountain View, California) and Agilent Technologies (Palo Alto, California) have jointly developed a kit to perform cell analysis assays on Agilent's 2100 Bioanalyzer. The new Cell Fluorescence LabChip runs on a new version of the Bioanalyzer with the enhanced capability to drive fluid movement through channels of the chip by pressure or vacuum, in addition to the electrokinetic movement used in the original Bioanalyzer. With the addition of the new kit, the Bioanalyzer provides researchers with a single analytical platform for performing DNA, RNA, protein and cellular analyses and other common analyses, including apoptosis analyses, surface and intercellular protein expression determination and viability assays.

Cardima (Fremont, California) reported progress of its multicenter study for treating atrial fibrillation (AF) originating in the pulmonary veins of the heart. Four trial patients in the second study were treated with the company's Revelation Helix radiofrequency ablation microcatheter, targeting arrhythmias originating of the left side of the heart. The Revelation Helix combines the ability to both map and ablate using a single microcatheter with a helical-shaped tip. Both diagnosing and treating a patient with a single catheter allows the physician to place the microcatheter in the appropriate position in a single-step procedure. Cardima said it would seek regulatory approvals in Europe before the end of the year. Cardima developed its microcatheter systems for the mapping and treatment of AF, which it believes is a potential $6 billion market.

Cell Robotics International (CRI; Albuquerque, New Mexico) introduced its Pathology Workstation at last month's American Society for Clinical Pathologists/College of American Pathologists meeting in Philadelphia, Pennsylvania. The company said that the workstation would allow pathologists to automatically cut out and retrieve cells of interest from a biopsy for DNA and RNA analysis to provide a definitive cancer diagnosis. The new workstation also is able to support future research on pathogenic agents, such as anthrax, smallpox or botulism. The workstation is designed to provide pathologists with new tools for the retrieval of specific cells to allow molecular analysis of biopsies. Once the specimen of interest is identified, the pathologist uses the laser to automatically cut around it using the new auto-cut software. CRI also launched its Workstation, which uses LaserTweezers and LaserScissors for research in stem cells, transgenic animal production, functional genomics, and the isolation and genetic analysis of pathogenic bacteria like anthrax. It upgrades the current version by adding analytical imaging software and LaserScissors.

Cerus (Concord, California) and Baxter Healthcare (Deerfield, Illinois) discussed preliminary results from the Phase Ic clinical trial of their Intercept Red Blood Cell System, a pathogen inactivation system being developed to protect against transmission of infectious diseases through red blood cell transfusions. The results showed that Intercept red blood cells were well-tolerated and demonstrated comparable recovery and survival performance to red blood cells that had not been treated with the pathogen inactivation process. The data were presented at the American Association of Blood Banks meeting in San Antonio, Texas. Preliminary results from the two-part study of 40 participants showed that mean survival of Intercept red blood cells following infusion was 62.2 days, which did not show statistical difference from the 61.1 days of survival of untreated red blood cells. In addition, the two groups showed comparable mean recovery, with 79.4% of Intercept red blood cells surviving 24 hours after infusion compared to 84.7% in the untreated group. Another study showed that Intercept red blood cells were well tolerated, with no serious adverse events observed. Cerus and Baxter are collaborating on the development of these blood systems to enhance the safety of blood transfusions. The companies are seeking U.S. and European approval of the Intercept Platelet System.

CIBA Vision (Duluth, Georgia) reported FDA approval for its Focus Night & Day contact lenses for extended wear, continuous for up to 30 nights. The lenses are made from a silicone hydrogel material that supplies six times more oxygen to the eye (an oxygen transmissibility of 175 Dk/t) than ordinary disposable lenses and 40% more oxygen than the minimum threshold (125 Dk/t) recognized by independent researchers for overnight wear. The lenses will be available in the U.S. later this fall and will be offered in two base curve sizes of 8.6 mm and 8.4 mm and the power range will include +0.25D to +6.00D in 0.25D steps, - 0.25D to -8.00D in 0.25D steps and -8.50D to -10.00D in 0.50D steps. CIBA, the eye care unit of Novartis AG (Basel, Switzerland), develops optical and ophthalmic products and services.

Collagen Matrix (Franklin Lakes, New Jersey) has received 510(k) clearance from the FDA to market the Collagen Nerve Cuff, a resorbable, flexible tubular guide for the repair of severed peripheral nerves. Peripheral nerves, particularly in the extremities, may become traumatically or surgically injured to the extent that they are severed. The company said that the severance of peripheral nerves frequently results in a permanent loss of motor and sensory function. Severed axons of peripheral nerves can regenerate spontaneously; however, without guidance, the axons are not able to reconnect with the nerve endings for a return of motor and sensory function. The company said the Collagen Nerve Cuff provides a protective environment and guidance to bridge the severed peripheral nerve for a return of function. The company plans to obtain a CE mark for marketing the product in Europe in 2002. It has received investigation device exemption approval from the FDA for the evaluation of a nerve guide product in the repair of cavernosal nerves in prostate surgeries. In addition to the Collagen Nerve Cuff, the company is research and development of a bioactive nerve guide for the repair of large peripheral nerve defects where there is no commercial product available at this time. Collagen Matrix makes collagen-based extracellular matrices for guided tissue and organ regeneration.

CryoCor (San Diego, California), a development-stage company, said that patient enrollment has been completed in the first clinical trial of its CryoCor Cardiac Cryoablation System for the treatment of atrial fibrillation and other cardiac arrhythmias. The company said it completed patient enrollment in mid-August in its initial clinical trial that began in mid-May. The company enrolled approximately 50 patients treated for atrial fibrillation, atrial flutter and other cardiac arrhythmias at three centers located in the Netherlands, Germany and Hong Kong. After completion of the patient follow-up period, CryoCor said it will use the clinical data to file for CE mark approval before year-end and expects to attain necessary approvals by early 2002, permitting CryoCor to continue to evaluate the system in the European Union and other countries recognizing the CE mark for medical use. The company also has applied for an investigational device exemption from the FDA to begin trials of the system in the U.S.

DOBI Medical Systems (Mahwah, New Jersey) said the FDA accepted the second of five modules of its premarket approval application for its Dynamic Optical Breast Imaging System, called ComfortScan. DOBI is seeking approval for the non-invasive imaging system to be used as an adjunct to mammography to differentiate malignant from benign tumors by detecting angiogenesis development in the breast.

Endologix (Irvine, California) has submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) the results from a multicenter trial investigating the efficacy of its stent graft for the treatment of aortic aneurysms. Endologix said it is the first commercial manufacturer to complete an all-Japanese patient cohort for this technology and expects to be the first to market with its technology. Dr. Shin Ishimaru of Tokyo Medical University (Tokyo) is the principal investigator for this study, and recently presented the results of this trial at the International Society of Cardiothoracic and Vascular Surgeons meeting in Cancun, Mexico. The Endologix technology was successfully deployed in 95% of the patients that had an abdominal aortic aneurysm. During the clinical follow-up period, all of the patients had an aneurysm that either reduced in size (44%) or stopped enlarging (54%). There were no patient deaths. Endologix currently sells its products through distributors in Europe and selected markets outside of the U.S. The company is conducting an ongoing clinical trial in the U.S. with plans to obtain marketing approval to introduce its products into the domestic market between 4Q03 and 1Q04.

Exact Sciences (Maynard, Massachusetts) said it has begun enrolling patients in a multicenter study of its noninvasive, genomics-based technology to detect colorectal cancer in average-risk patients. The study, being conducted in more than 40 centers across the U.S., is expected to provide large-scale validation the company's genomics-based PreGen technology to detect colorectal cancer. In addition, the data will provide support for the use of PreGen technology as a new option in colorectal cancer screening. Colorectal cancer, the second most deadly cancer in the U.S., has a five-year survival rate of more than 90% when detected at its earliest stage, thus making it a prime candidate for detection through regular screening, the company said. Exact Sciences is an applied genomics company that has developed proprietary technologies that may be used for the early detection of several common cancers, with colorectal cancer as its first target application.

Florence Medical (Wellesley, Massachusetts) received FDA clearance for its SmartFlow Multiple Lesion, a device that provides real-time blood flow data to use in assessing the severity of multiple stenotic lesions during cardiac catheterization procedures. SmartFlow uses computational fluid dynamics to convert pressure measurements from a pressure wire into a complete hemodynamic picture of each stenotic lesion in a single artery containing multiple lesions. The system displays coronary flow reserve, fractional flow reserve (FFR) and FFRTrue, the FFR for each individual stenotic lesion without the hemodynamic interference of the adjacent lesion. It also displays the baseline pressure gradient and the hyperemic pressure gradient. With SmartFlow, real-time FFRTrue is available during the procedure. It has been evaluated in over 200 patients in nine clinical centers in the U.S., Europe, Japan and Israel. In these studies, SmartFlow was used during angioplasty and stenting to measure the degree of stenotic disease and to evaluate the success of intervention.

Galen Holdings plc (Rockaway, New Jersey/ Craigavon, Northern Ireland) presented positive research results at the annual meeting of the North American Menopause Society, providing Phase III research results for what it said is the first intravaginal ring to provide long-term estrogen treatment for menopausal symptoms, which include both systemic vasomotor symptoms of hot flashes and night sweats, and local urogenital symptoms, such as vaginal dryness and painful intercourse. Research reported that more than 90% of women in the study said they would choose this form of estrogen therapy, if available. The ring provides estradiol, the naturally occurring form of estrogen, at a rate of 50 micrograms per day for three months, while maintaining stable blood levels of estrogen. In September, Galen launched the ring in its first market, the UK, under the brand name Menoring.

Gliatech (Cleveland, Ohio) reported on what it called the "disappointing" results of an independent re-evaluation of MRI data from the U.S. clinical study of Adcon-L, finding no significant difference in maximum scar scores between the treatment group and the untreated control group. In the study, the second major efficacy study of Adcon-L, two neuroradiologists evaluated MRI films to score the amount of post-operative scar evident for each patient six months after surgery. No statistically significant differences between Adcon-L-treated and control patients were evident. In the first, conducted in Europe, results showed that six months following surgery, those patients who received Adcon-L had a statistically significant reduction in both MRI scar and pain measurements as compared to the untreated control group. This data was reviewed and audited at the FDA's premarket approval meeting. In addition to the European efficacy study, the company said published literature on Adcon-L has indicated that physicians have observed less scar during re-operation. Gliatech is currently marketing the drug outside the U.S. in 39 countries. Additional clinical outcome endpoints, including pain measurements at six months following treatment, are being analyzed.

GeneMachines (San Carlos, California) reported that its RevPrep Orbit workstation showed successful results in beta tests of its nucleic acid capabilities. The product automates genomic sample preparation. When incorporated into an around-the-clock DAN purification schedule, the RevPrep purified 24 96-well plates of plasmids. RevPrep works with Array Centrifuge technology, licensed from Stanford University (Palo Alto, California).

Genteon (San Diego, California) released its first product, the Capella 400, a high-throughput 384 capillary electrophoresis system for DNA polymorphism analysis. Capillary electrophoresis is the standard for the detection and analysis of genetic differences known as polymorphisms, such as SNPs, microsatellites and RFLPs. With 384 capillaries in a rotating array, Genteon's instrument has four times the capacity of the largest currently available systems, the company said. Genteon also has developed a proprietary chemistry for SNP genotyping that eliminates the use of costly fluorescent dyes. These patent-pending reagents will be offered with the Capella 400 for the genotyping application.

Inrad (Grand Rapids, Michigan) launched the UltraClip Image Guided Tissue Marker in response to what it called "overwhelming" interest generated in May at the Society of Breast Imaging conference. The company, in partnership with Dr. Richard Chesbrough, has developed UltraClip, which allows a suspicious breast lesion to be easily marked immediately after a core biopsy procedure. If the core biopsy results are abnormal, the already deployed UltraClip is readily visible under X-ray, ultrasound or MRI to aid in lesion re-excision. If the results are benign, the UltraClip is left in place as a permanent marker for long-term surveillance. "The clip is pre-loaded into the needle and ready to be deployed in a matter of seconds. Also, the needle and clip are echogenic, making them easy to see under ultrasound," Chesbrough said. He added that the UltraClip may also be useful for pre-chemotherapy marking of malignant lesions. Inrad manufactures medical devices serving the radiology community.

Integrated Surgical Systems (ISS; Davis, California), a pioneer in medical robotics and the world leader in image-directed, semi-autonomous robotic products for surgical applications, said the first Robodoc Surgical Assistant System hip replacement surgery has been completed at its second clinical trial site, the University of Arkansas Medical Sciences Center (Little Rock, Arkansas). The U.S. clinical trials, which require a total of 188 subjects at three sites, began in December 2000. Since then, 35 successful procedures have been performed at Sutter General Hospital (Sacramento, California). While the company said it hoped clinical trials at the University of Arkansas would begin in early 2001, the Institutional Review Board (IRB) approval process took longer than anticipated. The addition of the third clinical trial site is also dependent upon IRB approval, but the company hopes that all clinical trial surgeries can be completed by mid-2002. At the conclusion of the clinical trials, the company said it would seek FDA clearance to market the system in the U.S. Robodoc has been used to perform more than 9,000 joint replacement procedures in Europe and Japan.

Iridex (Mountain View, California) said that Noridian Mutual Insurance, a Medicare Part B Carrier, will begin to cover transpupillary thermotherapy (TTT) procedures administered to treat choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (AMD) effective for dates of service on or after May 1. Noridian is the Medicare Part B carrier for Alaska, Arizona, Colorado, Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and Wyoming, and is the first Medicare carrier to make a written coverage decision approving the use of the TTT protocol for the treatment of wet AMD. The company said that results of a study performed at Retinal Consultants of Arizona were instrumental in Noridian's decision to cover the procedure. The study results will be presented at this month's annual meeting of the American Academy of Ophthalmology in New Orleans. The reimbursement amount varies by geographic location but reports to date indicate coverage is in the range of $670-$704. TTT is a minimum intensity laser photocoagulation protocol that can result in closure of CNV with relative sparing of the neurosensory retina compared with conventional laser photocoagulation techniques, said the company.

Medennium (Irvine, California) received CE mark approval for its new hydrophobic acrylic intraocular lens, the Matrix Acrylic. The lens is implanted following extraction of the natural lens after cataract surgery. The lens is one of three technologies being marketed in Europe, along with SmartPlug, a one-size-fits-all punctal occlusion device made of a thermodynamic acrylic material designed to treat dry eye syndrome; and the PRL, a phakic refractive lens designed for the surgical correction of myopia and hyperopia without the risks of corneal laser surgery. Medennium, which has received an investment from CIBA Vision, develops ophthalmic products to be made from patented polymer materials developed in house.

Micro Therapeutics (MTI; Irvine, California) said its flagship product, Onyx, a treatment for conditions that can lead to stroke, and related products were presented and demonstrated in two successful live cases to interventional neuroradiologists from around the world at the LINC 2001 endovascular neuroradiology workshop in Paris. A team used Onyx in two cases, and debuted the newest generation of several MTI products, including micro catheters, guidewires and occlusion balloons. The first case involved a large aneurysm in the carotid artery. Despite tortuous anatomy, the team was able to access the aneurysm site with MTI's new X-pedion Guidewire, and successfully fill the aneurysm with Onyx using MTI's Rebar Micro Catheter and new HyperGlide Balloon. In the second case, a massive arteriovenous malformation (AVM) in the brain was successfully embolized using Onyx with MTI's new UltraFlow Flow Directed Catheter. Onyx is a liquid embolic material that is delivered through MTI's micro catheters into a targeted vascular malformation, such as a brain aneurysm or AVM. Once inside the targeted malformation, the liquid quickly transforms into a spongy polymer mass designed to seal off the malformation from blood flow. Onyx is non-adhesive and is visible under fluoroscopy, allowing clinicians a clear view of the embolization procedure in real-time. In Europe, MTI has received CE mark to commercially promote Onyx for use in the treatment of aneurysms, AVMs and certain peripheral applications. In the U.S., the company is conducting pivotal clinical trials to study the use of Onyx in the treatment of aneurysms and AVMs.

Natus Medical (San Carlos, California) received FDA 510(k) clearance to market its ALGO 3 Newborn Hearing Screening system. The new system is designed to lower screening costs through improved test accuracy and reduced testing time, said the company. The system also is expected to reduce parental anxiety with a false positive rate 50% lower than other screeners. The system consists of new Flexicoupler disposable earphones, Jelly Tab sensors, specially calibrated cables and the ALGO 3 screener itself. Like other ALGO newborn hearing screeners, the system uses exclusive AABR technology that screens the newborn's entire hearing pathway, from the outer ear to the brainstem. ALGO screeners use completely standardized pre-set screening parameters and fully automated pass/refer results so a trained clinician is not required to conduct the test, according to the company. It added that it has a number of domestic and international patents pending for the new screener and the disposable earphones. The new Flexicoupler earphones and Jelly Tab sensors are compatible with all previous generations of ALGO screening equipment. The system was launched at last month's American Academy of Pediatrics meeting in San Francisco, California. Natus makes noninvasive crib-side screening devices for the detection and/or monitoring of common disorders in infants.

Pheromone Sciences (Toronto, Ontario) received CE mark approval for its PSC Fertility Monitor. Housed in a modern styled wristwatch-like device with an LCD readout, the product is worn during sleeping hours. A noninvasive device, it predicts ovulation by measuring ion changes on the surface of the skin. The device incorporates an interactive microprocessor combined with a biosensor enabling it to take up to 12 daily measurements from the skin surface and to evaluate the data in order to predict the status of the user, with four days advance notice, as being not-fertile, fertile or ovulating. Results can be viewed at any time on the device's LCD screen or as a printout for medical professionals. Pheromone is a biotechnology and medical diagnostics device company focused on technologies in the field of human reproduction and sexuality.

Quidel (San Diego, California) a provider of rapid point-of-care (POC) diagnostic tests, said that its QuickVue Influenza test product is being sold throughout Japan by the company's exclusive Japanese distributor, Sumitomo Seiyaku Biomedical, as the RapidVue Influenza A/B test. This follows receipt of a reimbursement code effective Oct. 1, and product approval in early May. Developed through a funded collaboration with GlaxoSmithKline, the QuickVue Influenza test is a rapid, three-step, one-reagent diagnostic test for the detection of influenza type A and B antigens, the two most common types of the virus. The company said that the test is simple to use, does not require special instruments and provides accurate results in 10 minutes or less.

Raymedica (Minneapolis, Minnesota) received a notice of allowance from the U.S. Patent and Trademark Office for an additional patent covering an alternative method of manufacturing the PDN prosthetic disc nucleus device. The PDN is a spinal implant designed to replace the function of a failed disc in the lower back. This will be the company'' 12th U.S. patent covering the PDN and related instruments, in addition to 16 international patents. The device has not yet been approved for marketing in the U.S. The PDN device is constructed of a special hydrogel core that absorbs fluid and expands when implanted in a surgically prepared disc nucleus cavity.

Thoratec (Pleasanton, California) reported a 63-year-old German man suffering from heart failure has become the first patient implanted with the company's Implantable Ventricular Assist Device (IVAD). It said this marks the first time a patient has been implanted with a VAD for the purpose of mechanical circulatory support for both the left and right ventricles. The procedure took place at the Heart Center of North Rhine-Westphalia (Bad Oeynhausen, Germany) and was performed by Drs. El Banayosy and Arusoglu. The IVAD is an implantable version of Thoratec's VAD System, which pumps blood to the body in heart failure patients awaiting transplant or recovery from open heart surgery and has been used in more than 1,700 patients worldwide. "We are in the process of identifying centers and getting them approved and hope to enroll our first patients in the U.S. trial during the current quarter," said president and CEO D. Keith Grossman. Key elements of the proposed safety and efficacy study in the U.S. include up to 30 patients who will be followed while on VAD support until device removal, at up to 10 participating heart centers.