Medtronic (Minneapolis, Minnesota) continues to pump products out of its heart failure device pipeline, hardly missing a beat from last year's bumper crop of 11 new releases. The newest FDA approval was disclosed in late February as the company said its InSync III cardiac resynchronization therapy system was given the regulatory green light. This is Medtronic's third cardiac resynchronization therapy (CRT) system released in the U.S., following the successful launches of the InSync and InSync ICD systems, and more products may soon follow.
Scott Papillon, senior public relations manager, noted that aside from the InSync III another CRT device, this time on the defibrillator side, is expected to gain approval soon. That device, the InSync Marquis, is the next-generation product to the InSync ICD, approved last June. Further back in the pipeline is the InSync III Marquis, a system that combines the best features of the InSync III and the Marquis defibrillator for the dual treatment of ventricular dysynchrony and ventricular arrhythmias. That device is already undergoing trials in Europe.
According to Medtronic, the InSync and InSync III devices are the only cardiac resynchronization products available in the U.S. designed specifically for patients who are not indicated for implantable defibrillators. The InSync III system enhances and builds on the technologies pioneered with the InSync device, which was the first implantable heart failure pacing system approved for use in the U.S. With InSync III, a new function called sequential bi-ventricular pacing has been added that allows physicians to independently program and control the sequence of contractions of the right and left sides of the heart. In clinical trials, this capability demonstrated additional benefits to patients indicated for cardiac resynchronization by adjusting the pacing sequence of the two lower heart chambers (ventricles) to improve heart performance. No other CRT device on the U.S. market has this sequential bi-ventricular pacing feature, the company said.
Elsewhere in the product pipeline:
Abiomed (Danvers, Massachusetts) said the FDA has completed its review of the company's premarket approval supplement requesting approval of a new drive and control system for its BVS product line. The FDA has determined that the supplement is approvable, subject to successful inspection of the manufacturing facilities of Abiomed's contractor for electronics manufacturing. The new AB5000 Circulatory Support System console will drive one or two BVS 5000 blood pumps, either in the hospital or for transport of patients between hospitals. Incorporating an electronic interface, the AB5000 is designed to improve the convenience and ease of use of the current BVS blood pump and to serve as a common platform for future heart-assist blood pumps currently under development at Abiomed.
ACMI (Southborough, Massachusetts) and ProstaLund (Lund, Sweden) reported the launch of the CoreTherm System for office-based treatment of benign prostatic hyperplasia (BPH). ProstaLund recently received premarket approval clearance to market the CoreTherm system and named ACMI its U.S. agent. ACMI has exclusive distribution rights in North and South America and will begin to train urologists throughout the U.S. immediately. Microwave thermotherapy is a minimally invasive office-based procedure for the treatment of BPH, an enlargement of the prostate, affecting nearly 25% of all men over the age of 50 in the U.S. Until recently, the most common method for treating BPH was a transurethral resection of the prostate (TURP), a surgical procedure performed under anesthesia. In a randomized multi-center study performed in Scandinavia and the U.S., there were no significant differences between CoreTherm treatments and TURP with regard to International Prostate Symptom Score, peak flows, detrusor pressure, prostate volume or residual urine volume. The study also showed that CoreTherm treatments resulted in fewer serious adverse events in the lower urinary tract compared to TURP. ProstaLund's next-generation microwave system has received the CE mark, with more than 100 systems being used outside the U.S.
AlloSource (Centennial, Colorado), one of the nation's largest non-profit tissue bank cooperatives, said it has added AlloFuse demineralized bone matrix (DBM)(1), configured in both putty and gel formulations, to its allograft product line. The addition of AlloFuse DBM Putty and Gel completes AlloSource's offering of allograft products, the company said. AlloFuse DBM Putty and Gel is made from human bone and contains DBM combined with a reverse phase medium poloxamer known as RPM. The clinical efficacy of DBM in the promotion of bone growth is widely accepted in the orthopedic field and the safety of RPM has been evaluated in animal studies. AlloFuse DBM will firm upon warming to body temperature and resists irrigation in surgical environments. In addition, RPM keeps the DBM where it is meant to be, which allows for the formation of new bone. Both the putty and gel grafts contain DBM with RPM and can be used in most places where bone formation is desired (e.g., spine surgeries or bone-defect surgeries). Graft selection is based on surgeon preference.
Aspect Medical Systems (Newton, Massachusetts) has entered into a multi-year licensing agreement with Dixtal Biomedica (Manaus, Amazonas, Brazil) to integrate Aspect's Bispectral Index (BIS) technology into Dixtal's patient monitoring systems sold in Brazil. Approximately 6,000 Dixtal DX2010 and DX2020 multi-parameter patient monitors are installed and capable of accepting the new BIS module. Dixtal said it expects that a BIS module solution will be commercially available in Brazil in June.
Bayer Diagnostics (Tarrytown, New York) received FDA clearance for Ascensia Breeze, its newest blood glucose monitor. The first meter to debut under Bayer's new Ascensia line of diabetes care products and services, the Ascensia Breeze blood glucose monitoring system is designed to assist people in self-monitoring their blood glucose regularly. The Ascensia Breeze system will be commercially available in 3Q03. Bayer said the Ascensia Breeze system uses an easy-to-load disc with 10 individual test strips.
Boston Scientific (Natick, Massachusetts) said it has started its TAXUS V clinical trial, which plans to evaluate more than 1,100 patients at up to 70 sites in the U.S. The first patients were enrolled earlier this month in the de novo lesion portion of the trial. The TAXUS V trial is an extension of the TAXUS IV study designed to assess the safety and efficacy of a slow-release formulation of paclitaxel to support regulatory filings for U.S. product commercialization. TAXUS V will study a higher-risk patient population than TAXUS IV, including patients with smaller vessels as well as those with longer lesions requiring overlapping stents. Boston Scientific also said that it has submitted the second module of its premarket approval application for its TAXUS paclitaxel-eluting coronary stent system to the FDA. The company submitted the first module in February and plans to submit the fifth and final module in June. Boston Scientific launched the TAXUS drug-eluting stent in Europe and other international markets in February and anticipates launching the product in the U.S. late this year. The TAXUS clinical program is a series of studies designed to collect data on Boston Sci's polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is under way. TAXUS VI is studying patients with complex coronary artery disease and has completed enrollment. Boston Scientific also has initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of the TAXUS system. A European post-market registry (Milestone II) is expected to begin soon following the recent European commercialization of the TAXUS product. TAXUS uses the Express2 coronary stent system as its platform.
Cardima (Fremont, California) said that its pre-market approval application for the Revelation Tx will be reviewed during a May 29 meeting of the FDA Circulatory System Devices Panel. The company further reported that its manufacturing facility was recently inspected as part of the ongoing FDA marketing approval process and the company has subsequently received a letter certifying compliance with FDA manufacturing standards. Cardima developed the Revelation Tx linear ablation microcatheter system as a minimally invasive, single-use product that may have the potential for curing AF. In the U.S., Cardima believes the Revelation Tx to be the first device to treat AF that has been submitted on a premarket approval application to the FDA. Cardima submitted the PMA to the FDA last September and was granted expedited review status by the FDA in November. That application is still pending before the FDA. Clinical trial data from the Revelation Tx microcatheter demonstrated safety and promising efficacy.
Cbyon (Mountain View, California) said the U.S. Patent and Trademark Office issued two broad, enabling patents relating to the company's surgical navigation and visualization technology, the Cbyon Suite. The patents, titled "Apparatus and Method for Calibrating an Endoscope," relate to a device and process for volumetric calibration of an endoscopic field of view with respect to the tracking element on the endoscope. The company said the newly issued patents further solidify its intellectual property position by supporting Image Enhanced Endoscopy, a technology that synchronizes live video endoscopic images with information obtained from patient imaging data. This technology augments endoscopic procedures by providing "see through" capability, adding an extra safety margin to endoscopic procedures. That should allow much broader use of endoscopic techniques and minimally invasive surgical applications, the company said. The Cbyon Suite has received 510(k) clearance by the FDA as well as European CE Mark approval for use in spine, sinus and neurosurgery applications.
ev3 (Minneapolis, Minnesota) introduced Nitrex Nitinol Guidewires offering a streamlined guidewire product line specifically for peripheral interventional procedures. Nitrex Guidewires will replace ev3's Ultra-Select and FlexFinder Nitinol Guidewire brands. Nitrex Nitinol Guidewires are constructed of a solid nitinol core from proximal to distal tip, designed for maximum kink resistance and atraumatic navigation during challenging interventional cases. The new guidewire is enhanced to optimize general access, crossing and device delivery.
Guidant (Indianapolis, Indiana) reported the first U.S. implant in its latest heart failure study, DECREASE HF (Device Evaluation of Contak Renewal 2 and Easytrak 2 Assessment of Safety and Effectiveness in Heart Failure). The study is designed to demonstrate the safety and effectiveness of the flexible pacing modes offered in Guidant's newest heart failure cardiac resynchronization therapy defibrillator currently available in Europe. The study will compare the current standard for delivering cardiac resynchronization therapy in which the right and left ventricles are paced simultaneously. Two additional programming options include resynchronization therapy with a left ventricular offset in which the ventricles are paced independently and a mode in which only the left ventricle is paced. The first implant of Guidant's Renewal 2/Easytrak 2 system was performed on March 7 by Dr. Michael Giudici at Genesis Medical Center (Davenport, Iowa). The DECREASE HF trial is a randomized study currently being conducted at sites across the U.S.
iCAD (Nashua, New Hampshire) said that it has received approval from the FDA to market a new version of its CAD software with the highest overall cancer detection sensitivity in the industry. The company said the software improves detection rates for calcifications and for masses, resulting in an overall detection rate, or sensitivity, of 90.5%. Computer-aided detection from iCAD can detect 23% of breast cancers an average of 14 months earlier than traditional mammography screening. iCAD said it offers the fastest CAD system available, the only system to look for asymmetries and the most effective system available to detect breast masses and cancers overall. The iCAD system is designed on a relational database platform which can improve productivity and reduce operating and capital costs at women's health centers by offering computer assisted detection as an integrated or integration-ready part of current or anticipated informatics systems, digital imaging resources and workflows.
Karl Storz Endoscopy-America (Culver City, California), an affiliate of Karl Storz GmbH, unveiled its new Flex-X Uretero-Reno-Fiberscope at the opening session of the 1st World Summit on Kidney Surgery at The Cleveland Clinic (Cleveland, Ohio). Meeting attendees had the opportunity to put Flex-X's revolutionary design and responsive handling to the test. During a live international telecast of advanced ureteroscopy, Flex-X demonstrated superior performance in several important categories, including ease of entry to the lower pole calyces and navigation of the entire renal collecting system. Flex-X's new fiber bundle system also was credited with delivering larger, higher resolution images for improved tissue differentiation. Single-lever control of the bending section is the most important design feature of Flex-X, providing surgeons with intuitive navigation and operational control. Flex-X enables active deflection 270 degrees in either direction for complex navigation maneuvers and a thorough diagnosis. It adapts to a wide range of anatomical shapes with a bending section that features a decreasing radius. The cable design reduces cable forces for a longer cable life and long-term retention of the articulation specification. A generous working channel allows the use of a wide choice of instruments, including the latest laser technologies. The company said Flex-X facilitates accurate positioning and ease of use. In some cases, insertion can even be performed without a guidewire.
MacroPore Biosurgery (Frankfurt, Germany/ San Diego, California) said U.S. patent No. 6,531,146 has been issued for the company's bioresorbable thin film, SurgiWrap. The company said the U.S. Patent and Trademark Office allowed all of the claims in the patent application, which include claims directed to postsurgical scar-tissue reduction throughout the body and smooth-surfaced barrier maintenance between the healing postsurgical site and the adjacent surrounding tissue. In Europe, SurgiWrap has received CE mark approval to prevent postsurgical adhesions in cardiovascular, general, spinal and obstetric surgeries. In the U.S., it is approved for soft tissue support and reinforcement, and for adhesion prevention in specific ENT (ear, nose and throat) procedures.
Mallinckrodt (St. Louis, Missouri), a business of Tyco Healthcare, said that the company's Optimark contrast media is now the first and only magnetic resonance imaging agent that is FDA approved for administration by power injection. Optimark contrast media is non-ionic and low in osmolality. It is packaged in plastic Ultraject prefilled syringes compatible with Mallinckrodt's Optistar LE injector and glass vials in a range of sizes.
Masimo (Irvine, California) said that it has completed development and testing of a new very low power and low-profile pulse oximetry printed circuit board. The MS-11 uses about 125 mW, roughly half the power of the MS-7 board and one-16th the power of Masimo's first OEM printed circuit board, the MS-1. The MS-1, MS-3, MS-5, MS-7 and MS-11 boards carry the full Masimo SET signal processing algorithm and are sold to Masimo's licensees for incorporation to their patient monitors and therapeutic devices. Once integrated, these instruments then give Masimo SET performance with any of the full line of Masimo single-patient or reusable sensors. To date, Masimo has licensed its Signal Extraction Technology for pulse oximetry to more than 35 patient monitoring companies, representing more than 60% of the pulse oximetry market. Measuring the size of a business card, the MS-11 allows the motion and low perfusion performance of Masimo SET to now be available in battery operated and hand-held devices.
Meridian Co. Ltd. (Seoul, Korea) said that its U.S. subsidiary, Meridian America Medical, has begun sale of the ABR-2000 (Autonomic Bioelectric Response Recorder) in the U.S. market. The ABR-2000 is an automatic, whole body-screening device used to detect stress-related problems and to identify that portion of the human body that is experiencing a disturbance due to the stress. The company also has received FDA approval for another medical health equipment product, the McPulse, which is used for the measurement and analysis of PTG (plethysmogram) and APG (accelerated plethysmogram). The company expects to be ready to sell the McPulse in the U.S. market during the second half of this year.
nPoint (Madison, Wisconsin) introduced a new feature of its ProbeMAX carbon nanotube (CNT) atomic force microscope (AFM) tips. A scanning electron microscope (SEM) image will be provided with each ProbeMAX tip, allowing users to select the appropriate probe for their application. The ProbeMAX carbon nanotube probes consist of multi-wall carbon nanotubes or nanotube bundles mounted on commercially available silicon AFM probes. They offer long lifetime and the ability to measure high-aspect-ratio features. The probes are designed to replace conventional silicon probe tips in many intermittent-contact mode applications. Along with their high aspect ratio, CNT probes are wear-resistant and can be mounted to be perpendicular to the sample within 10 degrees. The tips, with their SEM images, are available as either a single multi-wall nanotube or a bundle of multi-wall nanotubes mounted on silicon probes.
Ortec International (New York) said that results from a multi-center pilot study in diabetic foot ulcers have been accepted for publication in Wounds: A Compendium of Clinical Research and Practice. According to the article, diabetic neuropathic foot ulcers treated with OrCel showed a faster rate of wound healing than those treated with standard of care alone. In addition, at the 12-week study endpoint, a greater proportion of ulcers treated with OrCel achieved 100% wound closure relative to ulcers that received standard of care treatment. The study was conducted at eight centers and involved 40 patients. Based on this data, the FDA approved the initiation of a pivotal trial in diabetic foot ulcers.
Orthovita (Malvern, Pennsylvania) has completed patient enrollment for its pivotal human clinical study in Europe for Rhakoss Synthetic Bone Spinal Implant to measure the safety and effectiveness of Rhakoss for patients undergoing cervical spinal fusion surgery. The pivotal study enrolled 70 cervical spinal fusion patients from nine sites in six countries. The study will now follow these patients for six months in preparation for filling for a CE mark by the end of this year. Degeneration of the discs between the vertebrae of the cervical region of the spine often results in severe pain in the neck and arms or in overt neurological symptoms. Surgical treatment typically consists of removal of the degenerated disc, followed by the placement of a structural implant in the disc space. In most cases, the implant is derived from cadaver bone, or made from titanium or carbon fiber composites. Bone tissue derived from cadavers has been linked to an increased risk of disease transmission, and synthetic bone repair products have so far not matched the structural strength and other characteristics of natural bone, the company said. Rhakoss is made of Orthobone, a biomaterial developed by Orthovita and designed to provide a synthetic alternative to structural cadaver bone with unique bioactive and bone bonding characteristics. Orthobone also ensures that Rhakoss has a similar radiolucency to natural bone, allowing surgeons to readily assess the success of the cervical spinal fusion procedure.
Philips Medical Systems (Andover, Massachusetts), a unit of Royal Philips Electronics, introduced a new CT Lung Nodule Assessment and Comparison option at last month's European Congress of Radiology meeting. The option comprises a program that provides quantitative information of lung nodules over time and supports recent findings that early, accurate detection and diagnosis of lung cancer can significantly increase cure rate. Philips' Lung Nodule Assessment (LNA) and Comparison Option, which recently received FDA marketing clearance in the U.S., is a new CT software tool that provides quantitative information on the size, shape and change of lung nodules over time. The new program, which is available on all CT systems in Philips' Mx8000 family, is designed to optimize performance and workflow of the lung nodule assessment process by matching measurements and results reported from current and previous CT scans of a patient's lung. The LNA program also allows for volumetric analysis of pulmonary nodules over time, enabling accurate assessment of growth time rate. Quantitative information can be reported on individual nodules during a single examination. Segmentations on each nodule are then automatically stored and retrieved when the study is loaded for follow-up comparison after a new examination is completed. The user can then load both the current and previous high-resolution images for linked viewing and comparison of nodules in each study. Recent studies have shown that when lung cancer is treated at an early stage, the cure rate is 70% or greater. CT exams are capable of detecting lung nodules as small as 2 to 3 millimeters, the majority of which could not be seen on the simultaneous chest X-ray examination. The decision can be made for either biopsy or repeat CT examination within 6 to 12 weeks to determine if the nodule has grown, and for further diagnosis, treatment or observation.
R2 Technology (Sunnyvale, California) showcased its new ImageChecker CT software with OmniCAD technology for the efficient detection of lung nodules in multi-detector computed tomography exams at the European Congress of Radiology meeting. At the same time, the company reported the first beta installation of the new product at the University of Vienna (Vienna, Austria), with plans for additional installations in Europe to follow. The ImageChecker CT product with OmniCAD technology is a computer-aided detection system that provides physicians the tools for evaluation of lung nodules in multislice CT exams. The CAD algorithms automatically highlight potential areas of interest and provide measurement and characterization information on the detected lesion that can be used to make clinical decisions. Additionally, R2's CAD technology allows detection of nodules in chest CT exams taken for any clinical indication, not just for lung cancer screening studies, the company said. The open architecture of the OmniCAD technology will provide CAD and other computer analysis for a wide range of imaging modalities, such as film-based and digital mammography as well as CT. The OmniCAD development plan calls for other CT applications, such as CT virtual colonoscopy, plus additional modalities, including CR/DR of the chest, to follow in subsequent releases.
Spinal Dynamics (SDC; Seattle, Washington) reported that a new surgical procedure designed to treat degenerative disc disease took place recently at The Washington Hospital (Washington, Pennsylvania). Donald Whiting, MD, led a surgical team in the implantation of the Bryan Cervical Disc prosthesis into a 44-year-old woman. According to Whiting, the procedure, which took just over two hours, went extremely well. The procedure was part of a study of about 550 patients nationwide focusing on the Bryan Cervical Disc prosthesis, a new method of treatment for patients with neck and/or arm pain and nerve and/or spinal cord irritation due to degenerative disc disease that has not improved significantly following at least six weeks of standard conservative treatment. The Washington Hospital was one of 21 hospitals in the U.S. participating in the investigational device exemption clinical study. Data from this study will be used to support a future marketing application to the FDA. The purpose of the study, which compares the Bryan implant to surgical fusion the standard way of treating this disease is to show that the Bryan implant is safe and effective. The Bryan Cervical Disc System is distributed outside the U.S. by Medtronic Sofamor Danek USA (Memphis, Tennessee). Medtronic and SDC announced last June that they had agreed to merge and that SDC would become a unit of Medtronic's Spinal and ENT organization.
TriPath Imaging (Burlington, North Carolina) has entered into a collaboration agreement with Quest Diagnostics (Teterboro, New Jersey), a provider of diagnostic laboratory testing, information and services. Under the terms of the agreement, Quest will begin offering TriPath Imaging's I3 Series integrated solution for cervical cancer screening, including the SurePath test pack, the PrepStain slide processor, and the FocalPoint slide profiler in selected locations. Quest will evaluate the I3 series relative to its immediate and future needs for cervical cancer screening. In addition, it has installed TriPath Imaging's Tele-pathology system in two locations and is evaluating various aspects of the system's utility.
Varian (Palo Alto, California) introduced its new Turbo-V401/301 NSF pump, designed to deliver tailored vacuum solutions to analytical instrument manufacturers, at PITTCON in Orlando, Florida. The Turbo-V401/301 NSF operates simultaneously at two or more different pressure levels, enabling multiple chamber pumping systems to be designed and operated with a single high-vacuum pump. The Turbo-V401/301 MacroTorr stages reduce power consumption, increase system design flexibility, and enhance overall vacuum system performance. The company said the split-flow technology simplifies processes and reduces the design and operating costs of analytical instruments such as LC/MS (liquid chromatography/mass spectrometer), TOF (time-of-flight), and ICP-MS (inductively coupled plasma - mass spectrometry). Varian said the compact design of the Turbo-V401/301 NSF makes it ideal for installation on smaller instrument chambers.
Viatronix (Stony Brook, New York) said it has completed integration of its V3D-Colon and V3D-Explorer packages with the Sectra PACS through Sectra's (Linkoping, Sweden) Clinical Solutions Network. The combined products were on display at the European Congress of Radiology meeting last month. This development results in more than 350 current Sectra PACS (picture archiving and communications system) users having access to V3D-Colon and being able to offer non-invasive colorectal cancer screening to a much larger audience, the company said. Viatronix said the V3D-Colon is the only product on the market that requires a simple preparation regimen for the patient, making the colonoscopy experience more acceptable to the patient. V3D-Explorer is a general-purpose diagnostic imaging solution designed as a multi-purpose 2-D and 3-D viewing and post-processing workstation that accepts DICOM-compliant magnetic resonance imaging and computed tomography images.
WorldHeart (Ottawa, Canada) has made a submission to Health Canada requesting approval for enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by having a quieter device and smaller, lighter, longer-lasting battery packs. These enhancements, which are commercially available in Europe and under review by the FDA, are the result of the evolution of extensive clinical experience with the Novacor LVAS. Improvements that will directly benefit recipients, according to the company, include quieter pump operation, new battery packs that are 40% lighter and operate for 60% longer and a smaller, quieter battery charger.
Zimmer Holdings (Warsaw, Indiana) reported beginning U.S. sales of the Trilogy Acetabular System Constrained Liner. Zimmer recently received FDA clearance to begin sales of the product, which has been available in markets outside of the U.S. since 2001. Constrained liners often are used in revision surgeries to address situations where the hip has a tendency to dislocate. The extra constraint provided by the liner design helps keep the hip replacement components properly mated, Zimmer said.