Guidant (Indianapolis) said last month that the FDA had approved an expanded indication for the company's portfolio of cardiac resynchronization therapy defibrillators (CRT-D). The expanded indication makes Guidant's CRT-D devices available to thousands more heart failure patients, potentially helping them to live both better and longer, the company said. The expanded indication comes after the unanimous 8-0 vote in June by the Circulatory System Devices Panel of the FDA's Center for Devices and Radiological Health recommending the increased patient population.

The expanded indication, effective immediately, is based on results from the Guidant-sponsored Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial – results of which were published in the May 20 issue of the New England Journal of Medicine. Based on COMPANION's outcomes, the company claimed that its CRT-Ds demonstrated reduction in the risk of all-cause mortality or first all-cause hospitalization, reduction in risk of all-cause mortality, and reduction of heart failure symptoms. Data presented during the June panel meeting showed that of the more than 1,500 heart patients with defibrillators studied in COMPANION, use of the device cut their risk of death by 36%, compared to those who only took drugs to help manage their heart conditions.

Chris Hartman, director of heart failure marketing for Guidant's Cardiac Rhythm Management unit, explained the importance of the expanded indication to the company. "In essence, what this is doing at the highest levels is recognizing this therapy as kind of a stand-alone," he told The BBI Newsletter. "[Now], with a heart failure diagnosis alone, you can get this therapy, whereas before it was always kind of thought of as a combined therapy. So now it [CRT-D] truly is a heart failure device that has a heart failure indication."

With the expanded indication, Guidant has estimated that about 35,000 more people per year could be candidates for the implants under its proposal to the FDA. Multiply that by the average selling price of about $35,000 per unit, and you get an annual incremental $1 billion increase in market size.

Separately, Guidant reported FDA approval of its newest stent system, designed to treat coronary artery disease in small vessels in patients with abrupt or threatened abrupt closure. The cobalt chromium technology of the Multi-Link Mini Vision Coronary Stent System provides physicians the thinnest-strut, small-vessel stent on the market for excellent acute- and long-term patient outcomes, the company said. The Multi-Link Mini Vision Coronary Stent System is indicated for patients with small vessels at risk of sudden closure.

Elsewhere in the product pipeline:

Abbott Laboratories (Abbott Park, Illinois) has introduced the second fully automated hepatitis A test in the U.S. for its AxSYM automated immunoassay instrument system. Used to aid in the laboratory diagnosis of previous or ongoing hepatitis A viral infection, the AxSYM HAVAB 2.0 assay detects the total antibody to hepatitis A (anti-HAV) in human serum or plasma. Primarily used to determine previous exposure to hepatitis A (HAV), the test also can be used to identify HAV-susceptible individuals for vaccination. The test completes Abbott's hepatitis A menu for the AxSYM system in the U.S. The company said it would be introducing additional AxSYM tests for other types of hepatitis in the U.S. into 2005.

Advanced Stent Technologies (AST; Pleasanton, California), a developer of bifurcated stent technologies, reported receiving FDA conditional approval to incorporate its bare-metal Petal coronary bifurcation stent and delivery system into its ongoing U.S. BOSS clinical trial and has enrolled the first patient at the Lindner Clinical Trial Center (Cincinnati). AST said three other clinical centers would be added to use the Petal stent system. The conditional approval specifies enrollment of up to 30 non-randomized patients using the Petal system. AST said it is responding to FDA questions to gain full approval for enrollment of up to 100 Petal patients and anticipates adding another four to six centers "in the next several months." The company previously enrolled patients into the BOSS trial using its SLK-View stent system, which features a side branch aperture lacking ostial elements and is the predecessor to the Petal stent. The Petal stent system incorporates "petal" strut elements that deploy about 2 mm into the side branch vessel, supporting and covering the carina and side branch ostium in a circumferential manner, while also providing continuous unimpeded access to the side branch through the side aperture created by the deployment of the strut elements. AST said the Petal system is potentially applicable to up to 25% of all percutaneous coronary interventions.

Beckman Coulter (Fullerton, California) has introduced the ACL 8000 coagulation analyzer, which features what the company terms an extensive test menu and advanced robotics for heightened precision and accuracy. About 40 clotting, immunoturbidimetric and chromogenic assays are available on the system for monitoring hemostatic disorders, including tests for D-dimer, Von Willebrand antigen and free protein S. The system can perform a D-dimer test in less than 10 minutes. Laboratorians also can combine test selections to obtain PT, APTT and fibrinogen results on up to eight samples in less than 10 minutes. The ACL 8000 offers automated reflex and rerun testing capabilities, while the system's clot signature curve technology aids in clinical interpretation of test results and troubleshooting. Beckman Coulter said coagulation labs also will benefit from the ACL 8000's computer-based centrifugal analysis, which allows up to 18 test samples at a time in each 20-cuvette rotor. The onboard capacity of the ACL 8000 is 40 samples and 18 reagents.

Bioimagene (Cupertino, California) reported the launch of virtual digital pathology products that it said will eliminate the "inefficient and laborious pathological analysis" of manually viewing images for life sciences researchers, pathologists and radiologists. Its offering consists of a set of bio-image analysis products built on iHarness, its technology platform that combines image analysis and pathological heuristics to provide a rapid research and diagnosis framework. Bioimagene said its suite of products enables users to analyze the glass slides more accurately, assisted by a robust image analysis rules engine; analyze slides anytime and anywhere via a web-based hosted application; share their analysis with fellow pathologists; provide second opinions rapidly without delay; provide faster diagnostic and research conclusions; and store and build a centralized reference library of slides and cases with complete analysis for future reference.

Cardica (Redwood City, California) reported clinical trial results from a multi-center study of its C-Port Distal Anastomosis System, proprietary technology used for creating a mechanical connection between two vessels during coronary artery bypass graft surgery. The trial, results of which were presented at the European Association for Cardiothoracic Surgery/ European Society of Thoracic Surgeons joint meeting in Leipzig, Germany, evaluated the safety and efficacy of the C-Port device relative to historical results achieved with traditional suture-based anastomoses, usually considered the most challenging part of bypass surgery. The openness or patency of the vessels joined with the C-Port device at six months after the operation was reported to be 96.9%, which compares favorably to an average six-month patency rate for traditional hand-sewn anastomoses of 84.9%, as determined from historical published data.

CardioDynamics (San Diego), manufacturer of BioZ Impedance Cardiography (ICG) non-invasive cardiac monitoring systems, reported the results of its PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study, demonstrating a significant relationship between BioZ ICG parameters and the occurrence of a major heart failure outcome. The PREDICT study results were presented at the 8th annual Heart Failure Society of America meeting in Toronto. The multi-center study followed 212 heart failure patients in outpatient clinics over a total of 2,316 visits. Each patient's BioZ ICG measurements were taken in addition to standard baseline variables and standard clinical variables.

Chiron (Emeryville, California) and Gen-Probe (San Diego) reported that testing with the Procleix West Nile Virus (WNV) Assay has been initiated under an investigational protocol on the Procleix Tigris System. The high-throughput, fully automated nucleic acid testing (NAT) system, developed by Gen-Probe, is designed to allow blood centers to test individual blood samples with greater operator efficiency and is being introduced into blood testing centers under an investigational drug application in regions with the highest prevalence of WNV. A pivotal clinical trial for the Procleix WNV Assay is currently being conducted at five U.S. blood centers.

Cook Critical Care (Bloomington, Indiana) reported FDA clearance to market a hydrophilic-coated version of its antimicrobial central venous catheter. The company said it will immediately market the new Cook Spectrum Glide Minocycline/Rifampin Impregnated Catheters to U.S. critical-care facilities. Spectrum catheters feature the company's antimicrobial impregnation process that helps provide protection on both the internal and external surfaces of the catheter. Spectrum catheters have been shown to be up to 12 times more likely to resist life-threatening catheter-related infections compared to chlorhexadine/silver sulfadiazine-coated catheters, according to Cook.

CryoLife (Kennesaw, Georgia), said Chris Darby, of the Oxford Transplant Center at Churchill Hospital (Oxford, UK), presented positive results of the company's SynerGraft arteriovenous (AV) access device, which showed secondary patency of 83% and freedom of infection of 94% at one year in patients undergoing dialysis. The SynerGraft AV access device, made of a bovine ureter, is approved in Europe for dialysis patients. Darby implanted the SynerGraft AV device in 17 high-risk patients who failed previous access methods for dialysis. The device uses the company's antigen reduction technology to remove antigens from the tissues, which appears to allow patients to receive implants without using immunosuppressant therapy.

Dade Behring (Deerfield, Illinois) said a study in the Sept. 14 issue of Circulation concluded that information regarding platelet function obtained with its PFA-100 analyzer may help in the risk stratification of patients presenting with myocardial infarction (MI). The research study indicated that patients with ST-segment-elevation myocardial infarction (STEMI) show significantly enhanced platelet function when their platelets are subjected to shear conditions similar to those found in a stenosed coronary vessel by the PFA-100 platelet function analyzer. The study also examined whether platelet function, as measured by the PFA-100 analyzer, may predict the extent of myocardial damage. It was found that platelet function results at presentation were found to be independent predictors of the severity of myocardial damage as measured by CK-MB or troponin. The analyzer uses high-shear methodology to detect platelet dysfunction.

DR Systems (San Diego) said the FDA has cleared its PACS (picture archiving and communications system) for diagnostic reading of digital mammography breast images. As part of the image diagnostic capability, mammography reading now can be integrated into the same radiology information systems (RIS)/PACS workflow efficiencies for patient image and information management, automated reporting, storage, archive and web-based distribution. Based on DR Systems' Release 6 software, the Dominator Diagnostic Workstation incorporates primary reading of digital mammography images; connectivity to any FDA-cleared DICOM digital mammography device or digitizer; and image interpretation on commercially available monitors. It also allows viewing of digitized prior film mammograms for comparison purposes; easier image storage and archiving within an existing DR Systems RIS/PACS infrastructure; and distribution of images and reports via CDs over the Internet.

Edwards Lifesciences (Irvine, California) has initiated a pivotal clinical trial of its next-generation Carpentier-Edwards BioPhysio aortic valve, which it said is the only replacement heart valve designed to mimic the physiologic motion of a natural heart valve. The first live implant of the new technology was simulcast in a presentation to attendees of the European Association of Cardiothoracic Surgery meeting last month. The surgery was performed at the Leipzig Heart Center (Leipzig, Germany), by Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris), and Friedrich Mohr, director of the department of cardiac surgery at the Leipzig Heart Center. The company said the enrollment period for the multi-center clinical trial is expected to last about 18 months, followed by an additional 12 to 18 months of post-procedural clinical monitoring and follow-up.

Gambro (Stockholm, Sweden) has launched Prismaflex, a new system for the treatment of acute renal failure and fluid management. The system is used in hospitals' intensive care units and succeeds Gambro's existing Prisma product. The first market rollout of Prismaflex covers Western Europe, Australia and Canada. At the end of the year, the company will commence worldwide rollout. Gambro said the Prismaflex machine is based on a new technology platform enabling both continuous renal replacement therapy and future therapies, such as therapeutic plasma exchange and hemoperfusion.

Karl Storz Endoscopy-America (Culver City, California) reported the addition of autoclavable cameras to the Image 1 Digital Imaging Platform. Although the new three- and single-chip digital camera heads can be sterilized by autoclaving, they provide the same levels of clarity and resolution available with previous Image 1 cameras. With parfocal optical zoom capabilities and digital fiberscope filtration, Image 1 autoclavable cameras automatically optimize the view for all endoscopes.

Medtronic (Minneapolis) reported FDA approval of the Attain 4194 Bipolar over-the-wire left-heart lead for use with cardiac resynchronization systems. The steroid-eluting lead has an angled shape and can be inserted using either a guidewire or a stylet delivery method, giving physicians an extra option to successfully maneuver and position the lead in a variety of difficult venous anatomies. The Attain 4194 lead is designed for use with the Medtronic InSync family of cardiac resynchronization therapy pacemaker and defibrillator systems, and expands the company's left-heart lead family to include a 6.2 Fr lead body for improved stability in larger vein sizes, with lengths of 78 cm and 88 cm. Medtronic also reported FDA approval and U.S. market release of the Sprint Fidelis family of defibrillation leads. At 6.6 Fr in size, Sprint Fidelis leads are the world's smallest right ventricular defibrillation leads, the company said, allowing for compatibility with 7 Fr introducers. The small size of the Sprint Fidelis helps improve passage into a patient's venous system for an easier implant, and minimizes venous obstruction, Medtronic said. Sprint Fidelis leads will be available in both quadripolar and tripolar configurations, with active and passive fixation options.

Natus Medical (San Carlos, California) reported the addition of the neoBlue mini light-emitting diodes (LED) phototherapy device to its line of jaundice management products for newborns. Designed as a smaller counterpart to Natus' existing overhead neoBlue LED Phototherapy Light, the neoBlue mini system offers clinicians a more compact and portable alternative to other available brands of phototherapy devices. The adjustable arm with pole mount facilitates attachment to a variety of patient care apparatuses.

OsteoBiologics (San Antonio) reported that it has received FDA clearance for its newest formulation of composite bone void filler device, PolyGraft TCP Bone Graft Substitute. The porous PolyGraft TCP material is comprised of a patented blend of polylactide-co-glycolide, tricalcium phosphate and polyglycolide fibers. The PolyGraft TCP is indicated to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure.

Siemens Medical Solutions (Malvern, Pennsylvania) reported FDA approval for Mammomat Novation(DR), a full-field digital mammography system for direct radiography that provides digital screening, diagnosis and stereotactic biopsy capabilities in a single system. The Mammomat Novation(DR) features a flat-panel detector based on amorphous Selenium (aSe) detector technology. This technology enables a direct conversion of X-ray to digital information. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail, the company said. At 25 cm by 29 cm, the image detector size of the Mammomat Novation(DR) also enables imaging of a larger range of patient sizes, and the system features a new paddle designed for easier and more comfortable patient positioning. It also features the MammoReport(Plus), a dedicated workstation for mammography, which provides high-volume mammogram reading and optimized workflow. Siemens also said that its Angiography and X-ray Division has introduced Interventional Cardiac 3D (IC3D) technology to create 3-D images of the coronary vessels in the heart. When paired with an Axiom Artis imaging system from Siemens, IC3D allows cardiologists to view the coronaries in 3-D with as few as two images, leading to precision in determining appropriate stent size and length, faster examination times, the use of less contrast medium and lower radiation dosages.

Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the Hip Access System, a joint-specific set of instruments designed to improve a surgeon's ability to access the hip joint during arthroscopic surgery. The system contains five instruments: the Hip Director Guide pinpoints the insertion site for the anterior portal; the Cannulated Switching Stick provides access into the hip capsule; the Portal Enlarger enlarges the size of the arthroscopic portal; the Modular T-Handle provides a firm grip and rotational control for advancing the Switching Stick and Portal Enlarger into the joint; and the Pistol Grip Slotted Cannula allows working instruments to be passed in and loose bodies to be removed from the joint. Smith & Nephew Endoscopy also reported the launch of the Endobutton CL BTB Fixation System for use in reconstruction of the anterior cruciate ligament (ACL) in the knee. ACL reconstruction using the Endobutton system restores stability by using a bone-tendon-bone (BTB) graft, which is harvested from the patient's own patella tendon with bone plugs at each end. The Endobutton fixation device holds the graft in place.

SpectRx (Norcross, Georgia) reported the availability of its new SimpleChoice easy and easy Pro insulin pump infusion sets with shorter catheters. The less-invasive catheters, which are about 25% shorter than standard catheters, are designed for a more comfortable insertion and wearing experience for people with diabetes who use insulin pumps. The SimpleChoice easy Pro is for use with Medtronic Paradigm brand insulin pumps. The SimpleChoice easy is for use with all other Medtronic pumps as well as all makes of Deltec, Animas and Disetronic pumps.

Starion Instruments (Saratoga, California) introduced at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS; Alexandria, Virginia) its new product, ENTceps, for ear, nose and throat (ENT) specialists. The product is based on Starion's Thermal Welding platform and is designed specifically for the soft tissue cutting and coagulation required for tonsillectomies, uvulopalatopharyngoplasty – such as for sleep apnea or snoring – and other ENT-related procedures.

Texas Instruments Sensors and Controls (Attleboro, Massachusetts) reported a new, hermetically sealed 4-20 mA pressure transducer/transmitter that it said is suited for medical equipment where accuracy, electro magnetic compatibility protection and high accuracy is vital. The new dry hermetic transducer features a stainless steel casing that is environmentally sealed to protect the advanced non-drift ceramic, capacitive sensing element from contaminants.

The University of Utah (Salt Lake City) has received U.S. patent No. 6,787,338 relating to methods of rapid nucleic acid amplification. The university said issuance of this patent reinforces its patent portfolio in the area of real-time nucleic acid amplification, quantification and melting analysis. The '338 patent and other patents in the portfolio are exclusively licensed to Idaho Technology (also Salt Lake City). The patent describes a method to perform PCR five to 10 times faster than believed possible with conventional systems. That allows completion of most PCR amplification reactions in less than 30 minutes, which is particularly important for pathogen detection in clinical diagnostic applications.

Venetec International (San Diego) reported the introduction of the StatLock IV Ultra Neonate catheter securement device, the first designed specifically for IV catheters in the neonatal nursery. StatLock IV Ultra Neonate replaces tape securement of peripheral IV catheters and is designed to provide longer catheter dwell times in the neonatal nursery. The company said the device can reduce tape-related problems including complications and discomfort for neonates, costs related to unscheduled catheter restarts and needlestick risk for nurses.

The Vitatron (Arnhem, the Netherlands) subsidiary of Medtronic (Minneapolis) reported the FDA approval and U.S. launch of the Vitatron T-series pacemaker, an advanced implantable heart device based on a digital processing platform. Digital technology enables the T-series device to collect heart rate information more quickly and precisely than other pacemakers, the company said. The device features dual-channel electrograms, which allows physicians to review heart rhythm patterns simultaneously in the upper and lower chambers of the heart.

Welch Allyn (Skaneateles Falls, New York) has launched the MacroView Otoscope, a hand-held device with a new design that provides a panoramic view of the ear. The MacroView Otoscope features 30% greater magnification than traditional otoscopes, nearly a full view of the tympanic membrane and an adjustable focusable eyepiece.

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