Kensey Nash (Exton, Pennsylvania), vying to join other companies in the distal protection market in the U.S., said last month that it had submitted a 510(k) application to the FDA for its TriActiv System. The TriActiv, formerly called the Aegis Vortex System, is a protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack. This is accomplished with three integrated system features: an embolic protection balloon, and a combined active flush and extraction system to remove the problematic debris from the target vessel.
The current market for these types of embolic protection systems, the company said, is estimated at $100 million worldwide and is expected to grow substantially over the next several years as next-generation products are developed and indications are expanded. The application for 510(k) clearance contained data from Kensey Nash's PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) trial, which compared the TriActiv device against other approved embolic protection systems for the treatment of saphenous vein graft disease.
Other distal protection systems on the market include Medtronic's (Minneapolis, Minnesota) PercuSurge GuardWire Plus System and Boston Scientific's (Natick, Massachusetts) FilterWire EX Embolic Protection system, both approved in the U.S. for use in saphenous vein grafts that have become occluded after coronary artery bypass graft surgery.
Elsewhere in the product pipeline:
Anodyne Therapy (Tampa, Florida) reported publication of a fifth peer-reviewed clinical study demonstrating restoration of sensation in the feet of patients with peripheral neuropathy using its device. The purpose of the study was to measure improvements in net health outcomes after sensation had been restored and patients continued using Anodyne therapy at home for 12 months. The study, which appeared in the July/August issue of Advances in Skin and Wound Care, said that the incidence of diabetic ulcers in the elderly diabetic population is typically between 7.2% and 11.6% per year. The incidence of ulcers in this study was 1.5%, or a 79% incidence reduction, according to Anodyne. The device uses photo energy therapy.
Agfa (Ridgefield Park, New Jersey) said the FDA has cleared its Impax Mammography Diagnostic Workstation. The multi-modality workstation delivers "one-stop" review and results distribution for digital breast-imaging studies, while also gaining access to other general imaging exams. The workstation also is cleared as a vendor-neutral solution for regionally approved digital mammography modality vendors. It incorporates ultra-high resolution, high-contrast monitors for soft-copy diagnosis of breast images and has substantial image manipulation tools and reliable study management tools.
American Bio Medica (Kinderhook, New York) said the Canadian Intellectual Property Office has issued two patents to the company, No. 2,181,775 for its device for the collection, testing and shipment of body fluid samples, and No. 2,334,802 for its device for the testing of fluid samples and process for making the device. The first patent covers a drugs-of-abuse testing kit that has a cup-like transparent container for retaining a fluid sample. The container has a slit to receive a multiple drug test card having a plurality of immunoassay test strips with visual endpoints to indicate the presence or absence of a particular drug. The second patent covers a test card for drugs of abuse that is the size and shape of a business card.
AngioDynamics (Queensbury, New York) reported FDA clearance for the Morpheus peripherally inserted central catheter (PICC) for use with computed tomography (CT) injectors. AngioDynamics said it expects to begin marketing the product in the U.S. this month. The Morpheus CT PICC is constructed of a biocompatible and durable material called Durathane, which offers increased stiffness on the proximal end for ease of placement, a softer distal end for patient comfort, and simplified site care. The company said the indications for use with CT injectors would allow physicians to use the existing PICC for both medications and CT imaging, avoiding the need for an additional access site.
Aventis (Bridgewater, New Jersey) reported FDA approval of OptiClik, a new reusable pen for injecting 24-hour Lantus (insulin glargine [rDNA origin] injection) for people with diabetes. Lantus is indicated for once-daily subcutaneous administration in the treatment of adult patients with Type 2 diabetes who require basal insulin for the control of hyperglycemia, and for adult and pediatric patients with Type 1 diabetes.
Beckman Coulter (Fullerton, California) introduced a new closed-tube sampling device on its Synchron LX20 Pro and Synchron LXi 725 clinical systems to accommodate Sarstedt S-Monovette tubes. CTS technology features a device with the ability to pierce the rubber specimen tube cap, allowing the sample to be aspirated automatically through the cap. The Synchron LX20 Pro's test menu includes more than 100 tests comprised of general chemistries, critical care chemistries, proteins, serologies and esoteric chemistries as well as therapeutic drug monitoring and drugs-of-abuse testing reagents. The Synchron LXi 725 features about 140 chemistry and immunoassay tests as well as data management and automated sample handling. The system's parallel processing technology enables the Synchron LXi to perform a basic metabolic panel in less than two minutes, while a troponin I test result can be delivered in about 14 minutes.
Biopure (Cambridge, Massachusetts) initiated the Phase II clinical trial of its Hemopure oxygen therapeutic in trauma patients at the Johannesburg Hospital Trauma Unit (Johannesburg, South Africa). Hemopure is a universally compatible, room-temperature-stable pharmaceutical candidate that is administered intravenously to deliver oxygen to the body's tissues. The single-center trial is a randomized, single-blind, parallel-group, standard-therapy controlled study. The primary objective is to assess the safety and tolerability of Hemopure, in a hospital setting, for emergency treatment of unstable patients who have significant blood loss as a result of blunt or penetrating trauma.
CardioMag (Schenectady, New York) said it has received FDA clearance for its magnetocardiograph (MCG) system, which can detect the magnetic field generated by a person's heart. An MCG procedure takes less than 10 minutes to perform, is risk-free, and does not require injections or radiation. The MCG system generates 1,000 images per heartbeat.
Cytogen (Princeton, New Jersey) reported the publication in the August issue of the Journal of Nuclear Medicine evaluating the safety and efficacy of external beam radiation therapy aided by advanced molecular imaging with the company's Prostascint imaging agent in recurrent prostate cancer patients following definitive surgical treatment. Prostascint is the first and only commercial product targeting prostate-specific membrane antigen, a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors.
Following expedited review, the FDA last month approved an injectable filler to correct facial fat loss in people with HIV. The filler, called Sculptra, is manufactured by Dermik Laboratories (Berwyn, Pennsylvania), the U.S. dermatology arm of Aventis. It is the first treatment approved in the U.S. for lipoatrophy, a condition that causes facial wasting, a sinking of the cheeks, eyes and temples, caused by the loss of fat tissue under the skin. Lipoatrophy is common in HIV patients. Sculptra is an injectable form of poly-L-lactic acid, which is a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been used for many years in dissolvable stitches, bone screws and facial implants. It is injected directly under the skin in the areas of greatest facial fat loss. The angle and depth of the injection are varied, based on the needs of each patient.
Eastman Kodak (Rochester, New York) reported the development of a new medical imaging X-ray film that will produce the same image quality available today but from half the radiation dosage currently required. It said the new general-purpose film would be the first radiographic film in 20 years to provide high-resolution imaging from a significantly reduced radiation dose. The film also will feature an increased "speed" that will reduce the need for retakes due to patient movement during exposure, further contributing to reduced radiation for patients.
Edwards Lifesciences (Irvine, California) reported the successful treatment of the first patient in its RESILIENT (Randomized Study Comparing the Edwards Self-ExpandIng LifeStent vs. Angioplasty-alone In LEsions INvolving The superficial femoral artery or proximal popliteal artery) clinical investigation using the LifeStent NT Self-Expanding Stent system to treat patients with peripheral vascular disease. The LifeStent is a percutaneously delivered flexible mesh tube that expands when deployed to prop open a diseased vessel. The RESILIENT study differs from other superficial femoral artery (SFA) investigations, Edwards said, because it is intended to demonstrate superiority, not equivalence, of the LifeStent NT Self-Expanding Stent system over angioplasty in treating blockages in the SFA and popliteal artery. Edwards also announced the limited launch of the first sizes of the NT Self-Expanding Stent system for use in treating biliary disease and said it would introduce additional sizes throughout 3Q04.
Elekta (Stockholm, Sweden) said more than 250 medical physicists at the American Association of Physicists in Medicine annual meeting in Pittsburgh, Pennsylvania, attended a company event that included a review of advances in image-guided radiation therapy (IGRT) with the Elekta Synergy Research Group members currently using Elekta Synergy. Elekta said the Synergy product is the first radiation treatment platform with an integrated imaging system, enabling doctors to obtain images of patients at the point of treatment, which allows them to visualize tumors at the time of treatment and more precisely target tumors while minimizing damage to surrounding tissue.
EP MedSystems (West Berlin, New Jersey) has received CE-marking from its European Notified Body for its integration of Boston Scientific's (Natick, Massachusetts) RPM Real-time Position Management technology with EP MedSystems' EP-WorkMate workstation. The EP-WorkMate with RPM is currently the only EP recording system available on the market to integrate advanced recording and stimulation, with anatomic modeling, advanced mapping and 3-D navigation features.
Guidant (Indianapolis, Indiana) reported the U.S. launch of the Voyager rapid-exchange (RX) Coronary Dilatation Catheter, following receipt of FDA approval. The company said the Voyager would provide "a dependable option for treating coronary artery disease in a variety of settings." The low-profile tapered tip contributes to overall system deliverability, which is important for successful treatment of patients with significant coronary artery disease. Guidant also reported FDA approval and market launch of three new products in its heart failure therapy product portfolio – the Rapido Advance lead delivery system, the Easytrak 2 lead and the Easytrak 3 lead. When used with a Renewal cardiac resynchronization device, the Easytrak 2 and Easytrak 3 leads provide physicians with choices of several configurations for stimulating the left side of the heart. The Easytrak 3 lead incorporates a shape designed to help physicians optimize lead placement in a broader range of vein sizes, the company said. With the addition of a second electrode, Easytrak 2 and Easytrak 3 leads are the only over-the-wire bipolar left ventricular leads available in the U.S., the company said. The Rapido Advance represents Guidant's fourth generation in heart failure lead delivery system technology. It is designed to enable physicians to have greater control and stability of lead delivery into the target vein, and to help physicians navigate difficult anatomy and optimize lead position.
Haemonetics (Braintree, Massachusetts) said it introduced an enhancement to its leuko-reduction, red cell collection technology that triples the time within which donated blood can be filtered to remove leukocytes, or white blood cells. Haemonetics' MCS+ system automates traditional whole blood collection methods to simultaneously collect blood components from blood donors and return the unused components to the donor. This process allows donors to donate twice the number of red cells than are donated by traditional, manual techniques. Donor leukocytes can cause transfusion complications in transfusion recipients, and previous technology required that blood be filtered within 24 hours of donation. Now, blood can be filtered for up to three days after donation. The FDA cleared this newest protocol last month.
Hitachi Medical Systems America (Twinsburg, Ohio) reported the upcoming release of its Version 2.0 enhancement package for the HI Vision 8500 Premium ultrasound system. This software enhancement will provide users with a host of imaging and operating improvements including a one-touch optimization feature and a new digital zoom with increased resolution and selectable sector size for maximizing frame rate. The upgrade will also include a new DVD+RW storage solution. The new operating software will support the HI Vision 8500's optional SonoElastography feature, which allows users to acquire tissue elasticity information in conjunction with conventional B-mode images.
Imaging Diagnostic Systems (Fort Lauderdale, Florida) reported receipt of another international patent for its CT Laser Breast Imaging system, European patent No. 1003419. The European equivalent of U.S. patent No. 6,044,288, it protects a key element in the optical technique used to determine the perimeter of an object being scanned. This boundary information is used during the reconstruction process and is considered an integral step in acquiring an image from its CT Laser Breast Imaging system and the Laser Imager for Lab Animals scanner.
Inamed (Santa Barbara, California) reported filing seven-year deflation rate follow-up data with the FDA for augmentation and reconstruction patients who are participating in the core clinical study of its Biocell Textured and Smooth Saline-Filled Breast Implants. The seven-year data, which build on five-year data previously filed with the FDA, are an interval update for product labeling that was required by the FDA as a condition of approval for Inamed's saline-filled breast implants in 2000. At seven years, the deflation rate for the Saline Augmentation cohort was 9.8% of the women studied, and for the Reconstruction cohort, the rate was 12.4%.
IsoTis OrthoBiologics (Lausanne, Switzerland) reported the commercial launch of OsSatura TCP (tri-calcium phosphate) in the U.S. and international markets, which it said extends its synthetic bone graft substitute offering with a faster resorbable product. The company said the rollout of OsSatura TCP to its distributor network began in late July. The OsSatura TCP product has a faster resorption time than the existing OsSatura BCP (bi-calcium phosphate) product, IsoTis said. The company said OsSatura TCP is the first of four new product launches this year, and the first since the 4Q03 formation of the company through the merger of GenSci OrthoBiologics and IsoTis SA.
Karl Storz Endoscopy-America (Culver City, California) launched the Image 1 Pendulum Camera Heads as an expansion of its imaging platform for the urology, ENT and ob/gyn markets. It said the Image 1 Pendulum system offers a number of advanced features, including the camera head's small size and multiple focal lengths. The camera design enables both image and telescope rotation without loss of image orientation. Because the system has no viewable eyepiece, 100% of available light enters the camera system, resulting in brighter images and improved documentation of still and moving images, Karl Storz said.
Lumenis (Yokneam, Israel) reported that its IPL Quantum SR is the only intense pulsed light (IPL) system that will be used as part of a new multi-center Phase II clinical study to be carried out at four U.S. locations by Dusa Pharmaceuticals (Wilmington, Massachusetts), with whom Lumenis has signed a development agreement. IPL provides gentle, non-ablative treatments that remove sun-induced freckles, most benign brown pigments, and redness caused by broken capillaries. The study will focus on rejuvenation of photodamaged skin, seeking to demonstrate that treatment is improved when IPL is used in conjunction with Levulan.
Medtronic Vascular (Santa Rosa, California) reported that it has received approval from the Japanese Ministry of Health, Labor and Welfare to market the Driver Coronary Stent System in Japan. The Driver stent also received reimbursement coverage and is available in Japan in diameters of 3.0 mm, 3.5 mm and 4.0 mm and in lengths of 9 mm, 12 mm, 15 mm, 18 mm, 24 mm and 30 mm. The cobalt-based alloy stent incorporates thinner struts, a low profile and advanced alloy to create a clinically proven, effective stent therapy option for patients, the company said. The Driver will be the first cobalt-alloy stent available in Japan.
Medtronic (Minneapolis, Minnesota) said it has introduced two versions of the Medtronic Octopus Tissue Stabilizer, completing a new generation of surgical instrumentation designed to facilitate closed-chest bypass surgery on coronary arteries without stopping the heart or splitting the sternum. Medtronic and Intuitive Surgical (Sunnyvale, California) will co-market the minimally invasive procedures as a strategy to eliminate the morbidity associated with splitting the breastbone. The da Vinci Surgical System from Intuitive uses a 3-D camera inserted through a port incision that provides a real-time image used to guide the surgeon's manipulation of the robotic controls. The Medtronic Starfish NS heart positioner, which was introduced in 2003, and the new Octopus NS (Non-Sternotomy) and Octopus TE (Totally Endoscopic) tissue stabilizers are then used to enable beating heart positioning and target artery stabilization via small port incisions.
Meretek Diagnostics (Lafayette, Colorado), an Otsuka subsidiary in the U.S., reported that Otsuka Pharmaceutical Co. (Tokyo) received FDA clearance to market the POCone Infrared Spectrophotometer. The company said POCone offers technological advancements to aid in the detection of active H. pylori infection, and to confirm eradication of infection through its 13C urea breath test technology and methodology. The in vitro diagnostic device is designed to measure the change of 13CO2 concentration in breath by infrared spectroscopic analysis and is intended for use in conjunction with the BreathTek urea breath test, which is commercially available through Meretek.
The Philips Medical Systems (Andover, Massachusetts) unit of Royal Philips Electronics reported the availability of the new Philips HeartStart Essentials Toolkit for Education. The toolkit, designed for the school environment, provides step-by-step implementation guidelines for establishing early defibrillation programs. The kit includes a sample Early Defibrillation Response Protocol, a reference guide which explores issues that may arise during and after school hours; a sample Early Defibrillation Program Policy, which summarizes legal and risk management, medical direction, program and site coordinator responsibilities, administration and maintenance, EMS involvement, training and the actual equipment; and the Early Defibrillation Program Implementation Guide, which provides background information on sudden cardiac arrest and identifies each step in the implementation process. As part of the HeartStart Essentials program, a member of the Philips HeartStart Clinical Implementation Team serves as a guide for each school throughout the implementation process.
Seattle Systems (Poulsbo, Washington), a manufacturer of orthopedic and physical rehabilitation products, has introduced the Sure Step Neuropathic Charcot Restraint Orthotic Walker (CROW), a custom orthosis used in treating Charcot degeneration of the foot and ankle. Charcot arthropathy is the progressive deterioration of a joint, such as a foot or ankle, which affects up to 35% of patients with diabetes. Seattle Systems said the Sure Step Neuropathic CROW is an effective alternative to total contact casting, offering greater comfort by putting minimal pressure on the foot and evenly distributing weight that provides the necessary support to enhance mobility. A custom-molded boot incorporates a bivalve custom pre-tibial and posterior shell with rocker bottom sole designed to offload the foot similarly to a total contact cast, but offering accommodation for each patient's particular needs. The company said the product also can be used for post-surgical protection and transition following foot and ankle reconstruction.
Siemens Medical Solutions' (Malvern, Pennsylvania) Angiography and X-ray Division said it has received FDA clearance for the Axiom Artis U, a moveable, digital C-arm imaging system. The system, which offers four times more generator power than any mobile C-arm system on the market, according to the company, is intended to support a variety of examinations, including angiographic interventions, cardiac interventions and surgical procedures. In order to accommodate space limitations at many facilities, the Axiom Artis U was designed with a small footprint. The design provides the combination of a fixed generator, a high-capacity X-ray tube and the flexibility of a movable C-arm. These configurations are intended to make the Axiom Artis U an ideal solution to accommodate hospital budget concerns and space restrictions, the company said. Siemens Medical Solutions also said the FDA has cleared the first magnetic resonance imaging system with 270 degrees accessibility. The Magnetom C! system features the most compact, mid-field, C-shaped magnet, with the smallest pole diameter available at 54 inches, the company said. The system is open on three sides to permit ease of side loading and optimized patient comfort, Siemens said. Magnetom C! features multi-channel imaging which allows simultaneous placement of up to four coils, increased comfort for patients and shorter exam times. The company said the system provides the most optimal image quality and signal-to-noise ratio (S/N) available at 0.35 Tesla. Magnetom C! offers enhanced gradients for rapid acquisition and highly differentiated image details, and iso-center imaging assures high image quality for all anatomical areas.
Smith & Nephew Endoscopy (Andover, Massachusetts) reported the release of the Clear-Trac Complete cannula system for use in arthroscopic joint surgery. Each cannula in the Clear-Trac system features a cap, or dam, that prevents fluid from escaping during the procedure. The cap can be removed, enabling surgeons to clear small pieces of bone or soft tissue from the treatment area without having to remove the cannula from the incision. The Clear-Trac system includes cannulae in nine sizes, enabling surgeons to find the best fit, depending on the size of the patient, the size of the joint being treated and the thickness of the muscle around it. Each cannula is made from a clear polyester material that is tinted so surgeons can distinguish between different cannulae during surgery.
St. Jude Medical (St. Paul, Minnesota) reported the first North American implant and Canadian regulatory approval of its SJM Epic Supra valve. The implant was performed by Robert Cossette, MD, chief of cardiac surgery at Sacre-Coeur Hospital (Montreal), on a 68-year-old man who was diagnosed with aortic valve stenosis. The SJM Epic Supra valve is an aortic supra-annular stented porcine tissue valve. The SJM Epic Supra valve was designed with an optimized stent-to-native annulus ratio to provide excellent hemodynamic performance and the sewing cuff and low-profile stent are designed for ease of implant in the supra-annular position, the company said The SJM Epic Supra is available in aortic sizes ranging from 19 mm to 23 mm. Both the SJM Biocor and SJM Epic valves are currently available in Europe, Canada, Latin America and Asia. Separately, St. Jude said that it has received an investigational device exemption from the FDA authorizing enrollment in the fourth phase of the RHYTHM ICD Study, which is evaluating its QuickSite 1056T bipolar left-heart pacing lead for cardiac resynchronization therapy. The first implants of the lead were performed at St. Elizabeth Regional Medical Center (Lincoln, Nebraska) and St. Thomas Hospital (Nashville, Tennessee). The QuickSite 1056T bipolar lead, with a 5.5 Fr diameter, is designed for placement in the coronary sinus to enable left-ventricular pacing in cardiac resynchronization applications. A polyurethane body transitions to a distal silicone tip section designed for optimal pushability, torque transfer and tip flexibility and a steerable, S-shaped distal tip is designed to improve maneuverability and anchoring of the lead at distal as well as more proximal locations within the coronary sinus. The QuickSite1056T lead is designed for use with the St. Jude Medical Epic HF CRT-D and the Atlas+ HF CRT-D.
Toshiba America Medical Systems (Tustin, California) has unveiled the Aquilion 64 CFX computed tomography (CT) system, optimized for examination of the coronary arteries. The Aquilion 64 CFX features Toshiba's 64-row Quantum detector for simultaneous 64-slice scanning with spatial resolution of 0.35 mm, volume imaging capabilities and proprietary software applications designed to automate complex diagnostic cardiac studies. The company said the Quantum 64 provides high-speed, high-resolution imaging with the lowest noise. Aquilion 32 users can upgrade to an Aquilion 64 with a simple field modification.
Varian Medical Systems (Palo Alto, California) received FDA clearance for a new AAA dose calculation algorithm in its Eclipse 3D radiotherapy treatment planning software. The algorithm improves radiation dose distributions in heterogeneous areas of the body such as the lung, where bone, dense soft tissues, and air pockets each interact with radiation in unique ways. Eclipse is the first software to offer clinicians both the AAA and the electron Monte Carlo algorithms for planning radiotherapy treatments, the company said. The Eclipse planning system with the AAA algorithm can produce a treatment plan for a large tumor volume in less than a minute. Varian Medical Systems also said it has received FDA clearance for a new suite of features that have been added to its On-Board Imager system for Clinac and Trilogy medical linear accelerators (linacs).
WorldHeart (Ottawa) said the FDA has approved its premarket approval supplement application for a revision to the labeling of the Novacor LVAS (left ventricular assist system) to reflect the current device reliability data available to patients and physicians. Notable in the revised labeling is the demonstrated performance longevity of the Novacor LVAS, which encompasses implant duration from zero to more than 36 months. The revised labeling is based upon statistical analysis of 1,077 device implants,
Wright Medical Group (Arlington, Tennessee) reported receipt of marketing clearance from the FDA for Allomatrix C, Allomatrix Custom and Allomatrix DR bone graft putties that contain demineralized bone matrix and specific volumes and configurations of donor matched, cancellous bone chips.
Zoll Medical (Chelmsford, Massachusetts), a maker of resuscitation devices and software solutions, said that the FDA has granted marketing clearance for the Lifecor Life-Padz WCD 3000S System, a next-generation, wearable cardioverter defibrillator for in-hospital use. The device, which is indicated for adult patients who are at risk for sudden cardiac arrest, consists of a wearable monitor, a three-lead electrocardiogram (ECG) system, and one set of therapy pads that are applied on the patient's chest and back. The device monitors the heart through the ECG electrodes. If a life-threatening rhythm is detected, it automatically delivers an electrical shock to restore a normal heart rhythm.