GE Healthcare (Waukesha, Wisconsin) introduced at a press conference held in conjunction with the EuroPCR meeting in late May a new cardiovascular imaging system that it believes will enhance clinicians' ability to diagnose and treat heart disease and enable more precise placement of interventional devices such as stents, balloons and filters.
The device, called the Innova 2100IQ, was unveiled at a gathering in the Concorde de Lafayette Hotel, adjoining the EuroPCR convention site in the Palais de Congr s.
The company said the Innova 2100IQ is capable of imaging the finest vessels and anatomy of the heart during placement of interventional devices. The new system is expected to play a critical role in helping clinicians treat a growing number of chronic heart and vascular conditions including atherosclerosis, a build-up of plaque that affects blood flow in arteries.
According to the American Heart Association (Dallas), atherosclerosis causes hundreds of thousands of heart attacks and strokes each year and accounts for nearly three-fourths of all U.S. deaths from cardiovascular disease.
Specifically, the device is what the company called a "state-of-the-art cardiac X-ray system that enables cardiologists to clearly visualize fine vessels from the heart to the legs both during diagnostic procedures and during placement of interventional devices." Developed in partnership with a team of interventional cardiologists, GE said it designed the Innova 2100IQ based on current clinical needs in the cardiac cath lab.
According to Laura King, vice president of global interventional, cardiology and surgery for GE Healthcare, this new system fits in nicely with the company's focus on performance imaging, "making sure that we can see all parts of the body."
She noted that the company is dedicated to developing technologies that improve the entire patient experience, from early and more accurate diagnosis to better treatment and management of diseases like atherosclerosis.
"We've completed more than two dozen clinical studies which demonstrate Innova's superior image quality," said King. "The Innova 2100IQ sets a new standard in cardiac image quality and enables cardiologists to visualize human vasculature more clearly than ever before."
Separately, GE Healthcare said its next-generation volume computed tomography (CT) scanner, the LightSpeed VCT, is being used to image the brains of stroke patients at University of Michigan Health System (Ann Arbor).
The company also featured its Stroke WorkUp application at the American Society of Neuroradiology annual meeting in Toronto. In a single rotation, the LightSpeed VCT creates 64 sub-millimeter images, totaling 40 mm of anatomical coverage, which are combined to form a 3-D view of the patient's anatomy for the physician to analyze. This speed and resolution are required for perfusion studies, to provide information to help doctors make an accurate and timely diagnosis of stroke, and to help doctors determine the extent of stroke damage.
Elsewhere in the product pipeline:
Boston Scientific (Natick, Massachusetts) reported that the FDA has approved extending the shelf life of its Taxus Express2 paclitaxel-eluting coronary stent system in the U.S. to 12 months from the current nine months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the Taxus system in particular the drug content, drug degradation profile and drug-release mechanism was maintained within FDA-approved specifications at 12 months. Boston Sci said the new approved U.S. shelf life for the Taxus is longer than any competing product. The extended expiration date applies to all sizes of the Taxus system for sale in the U.S. The company said it would immediately begin updating labels to reflect the 12-month expiration date. The shelf life for the Taxus system outside the U.S. remains unchanged at 18 months.
Cardima (Fremont, California) said it has filed an investigational device exemption (IDE) with the FDA to use its linear ablation technology to create continuous linear lesions in the left atrium of the heart for the treatment of chronic atrial fibrillation. The IDE includes the use of Revelation T-Flex microcatheter and the Intellitemp Energy Management System. The Revelation T-Flex allows a doctor to make either straight or shaped lesions in a single placement of the catheter. The Intellitemp Energy Management System allows the doctor to control all aspects of applying radio frequency energy through the Revelation T-Flex to the target tissue. When combining both the Intellitemp and the Revelation T-Flex, the doctor will have control of where placed, what shape, and how long any specific lesion they create within the heart, while saving procedure time.
CardioDynamics (San Diego), a manufacturer of impedance cardiography (ICG) technology, reported that the FDA has granted 510(k) clearance for the second phase of the BioZ Dx - which it said is the first ICG device with 12-lead electrocardiography (ECG). Market release is expected next month. The BioZ Dx is the result of a co-development partnership between the company and Philips Medical Systems (Andover, Massachusetts) and gives physicians the ability to assess the patient's electrical and mechanical cardiovascular status in one efficient platform. Existing BioZ Dx customers will be able to add the 12-lead diagnostic ECG capability with a field upgrade. With four dual sensors, the ICG portion of the BioZ Dx provides 12 parameters about the heart's pumping ability, including the amount of blood ejected by the heart each minute, the resistance it has to work against, and the amount of fluid in the chest.
CardioSoft (Houston) reported the completion of two clinical studies utilizing its new diagnostic cardiology tool, the HFQRS ECG, which measures and characterizes high frequency signals present in the QRS portion of the electrocardiogram, offering enhanced diagnostic information that supplements conventional ECG. The core technology initially was developed by researchers at the Johnson Space Center and is licensed from NASA by CardioSoft from the National Aeronautics and Space Administration. In the first study, involving 45 patients undergoing nuclear medicine scanning for myocardial perfusion, the HFQRS ECG correctly predicted ischemia more than nine out of 10 times. Study results were presented at the recent annual meeting of the International Society of Computerized Electrocardiology. In the second study, the HFQRS ECG performed with similar accuracy when used to assess 60 patients for the presence of cardiomyopathy. Results of this study will be presented in June at the 12th Congress of the International Society for Holter and Noninvasive Electrocardiology in Gdansk, Poland. CardioSoft said that additional investigations are under way at academic medical centers in Houston and other locations. CardioSoft is focused on developing ECG products for improved diagnosis and management of heart disease.
Cordis Endovascular (Warren, New Jersey), a division of Cordis, a Johnson & Johnson company, reported the U.S. availability of a new hydrophilic-coated catheter, Tempo Aqua. The diagnostic catheter is designed to provide physicians with better handling during complex, difficult-to-maneuver catheterization procedures. The Tempo Aqua catheter can be used in selective catheterization, carotid angiography and CTO cases and in emerging procedures such as uterine fibroid embolization and subintimal angioplasty. The Tempo Aqua catheter has a three-layer tip construction in which the radiopaque tungsten tip material is embedded between two nylon layers, which helps to minimize the potential for clotting and biocompatibility problems while maintaining the integrity and strength of the tip. Tempo Aqua products are available in 4 Fr and 5 Fr sizes, a variety of lengths up to 125 cm and a full range of shapes.
CryoCath Technologies (Montreal), a maker of cryotherapy products to treat cardiovascular disease, said the first patient was treated in its Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF), an investigational device exemption trial using the company's Arctic Front catheter for atrial fibrillation (AF). Dr. Douglas Packer, of the Mayo Clinic (Rochester, Minnesota), the principal investigator of this study, performed the successful procedure, with all four pulmonary veins electrically isolated using only the Arctic Front catheter. Three of the four veins were electrically isolated with one lesion application. The patient was diagnosed with AF several years ago and anti-arrhythmic medications have failed to control his condition, the company said. STOP AF will initially treat about 20 AF patients at two U.S. centers in support of the next larger pivotal stage. Initial three-month follow-up data on the first set of patients is expected to be available in 4Q05. The study will see the use of two CryoCath catheters, Arctic Front to treat AF and Freezor MAX to treat atrial flutter when concomitant to AF and to touch up gaps when the Arctic Front cannot fully isolate the veins.
DiaDexus (South San Francisco, California) said that the FDA has granted the company marketing clearance for the PLAC test, making it the first blood test to aid in predicting risk for ischemic stroke associated with atherosclerosis. The PLAC test measures an enzyme in the blood called lipoprotein-associated phospholipase A2 (Lp-PLA2). Because Lp-PLA2 and systolic blood pressure levels are additive in their ability to predict stroke risk, the PLAC test can help identify stroke-prone hypertensive patients.
Endologix (Irvine, California) reported that it has been granted approval by the Canadian Regulatory Agency, Health Canada Therapeutic Products Directorate to begin marketing its Powerlink System. Powerlink is an endoluminal stent graft for the minimally invasive treatment of abdominal aortic aneurysms. The system is a unibody self-expandable device, with a frame made of stainless steel alloy covered with an ePTFE graft. The Powerlink System is also approved in the U.S. and is marketed to select European countries through a distribution agreement with Edwards LifeSciences AG.
EP MedSystems (West Berlin, New Jersey) said it intends to expand the market for its Alert product platform with the submission of the Alert CS/RA premarket approval supplement to the FDA. The Alert CS/RA Catheter System replaces existing electrophysiology (EP) catheters, allowing the EP physician to not only perform routine diagnostic procedures with the patented CS/RA, but also easily cardiovert atrial fibrillation to normal heart rhythm during the procedure. The Alert system offers the advantage to cardiovert internally, via the catheter itself, without the need to interrupt the procedure for external cardioversion or the side effects associated with the use of an external defibrillator. The Alert CS/RA catheters are used in conjunction with the Alert Companion, a bi-phasic energy source manufactured by EP MedSystems.
Hitachi Medical Systems America (Twinsburg, Ohio) reported the release of Emory Cardiac Toolbox PETtools, a new software package for Avia, the multi-modality workstation for the Sceptre P3 PET/CT imaging system. Distributed under license from Syntermed (Atlanta), the optional PETtools will add broad capabilities for quantitative PET evaluation of cardiac perfusion to the Sceptre P3/Avia system. It offers databases with normal limits specifically for Rubidium and Ammonia PET studies and tools to evaluate FDG match/mismatch for cardiac PET, which allow physicians to conduct a more comprehensive cardiac evaluation. The Avia software release v.5.6 features the new Avia Lite Viewer, which will allow the user to burn cases directly to DVD/CD, along with providing a built-in viewer for physician review. Avia Lite Viewer expands the broad viewing capabilities of the multi-modality workstation to any PC, representing a substantial update in the Avia operating system software.
Medtronic Vascular (Santa Rosa, California) reported the completion of patient enrollment for the VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial, a pivotal study evaluating the safety and efficacy of the Talent thoracic stent graft system for the treatment of thoracic aortic diseases. VALOR is a large thoracic stent graft study, with three arms and 359 patients at 40 clinical centers in the U.S. It is a prospective, non-randomized, multi-center trial with a primary endpoint comparing "all cause" mortality at 12 months for open surgical repair against minimally invasive endovascular stent treatment using the Talent stent graft system. Medtronic will use the results of the VALOR trial for submission to the FDA for approval of the Talent system. Final VALOR trial results may be available in 2006.
MIV Therapeutics (Vancouver, British Columbia), a developer of next-generation biocompatible stent coatings and drug delivery technologies, reported the start of preclinical trials of a proprietary filtration device designed to be implanted in a main artery during cardiac procedures and heart surgery to divert particles that might otherwise reach the brain and cause strokes. The device was developed by SagaX Medical Technologies, a company developing a range of solutions to prevent complications that can result from cardiac procedures, and recently acquired by MIVT. One of the flagship technologies from SagaX is its Aortic Embolic Protection Device, a filter that can be placed in the aorta to filter and capture embolic particles that can cause strokes. The filtration prevents the embolic particles from traveling in the direction of the patient's brain. The embolic protection device SagaX is developing is designed for use during invasive heart procedures such as electrophysiology, valve dilatations and valve repair through angioplasty.
Spectranetics (Colorado Springs, Colorado) said it has received 510(k) clearance from the FDA to market its enhanced lead-locking device (LLD E) featuring design enhancements that it said will save deployment time, improve navigation through tortuous vascular anatomy and provide additional stability to the pacemaker or defibrillator lead being removed. The device was launched earlier this month at the Heart Rhythm Society meeting in New Orleans. The LLD E may be used alone or in combination with the Spectranetics Laser Sheath. Together, these devices are marketed as CLeaRS (Cardiac Lead Removal System). The LLD E uses Spectranetics' technology that locks onto the entire working length of the inner wall of the lead being removed, providing a stable platform for the lead extraction.
Stereotaxis (St. Louis) reported U.S. commercial availability of its new family of Cronus magnetically enabled .014" vascular guidewires. The guidewire family includes the Cronus Soft Support, Cronus Moderate Support, Cronus CS and Assert Guidewires. All guidewires have a new distal coating to enhance therapeutic device advancement and a Neo 55 magnet design for consistent magnetic deflection. The Cronus Moderate Support Guidewire has been designed for increased distal shaft support and the new Assert Guidewire has been designed to aid in lesion crossing applications. The new guidewire family integrates with the Stereotaxis Niobe Magnetic Navigation System to provide in vivo guidewire tip adjustments to facilitate guidewire advancement in tortuous vascular anatomy.
St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its Frontier II system for cardiac resynchronization therapy pacing (CRT-P) to reduce the symptoms of moderate-to-severe heart failure (NYHA Class III or IV) in patients who remain symptomatic despite optimal drug therapy. The Frontier II system is currently the only device family approved in the U.S. for treating patients (NYHA Class II or III) who have undergone an AV nodal ablation for chronic atrial fibrillation. The heart failure indication expands the number of patients who are eligible to have the device implanted. St. Jude said the Frontier II device is the smallest and longest-lasting CRT pacemaker in the U.S., which gives physicians flexibility to optimize patient care without compromising size or longevity. Among the advanced technologies offered in the U.S. version of the Frontier II CRT-P are independently programmable right ventricle and left ventricle amplitudes and pulse widths to meet the individual energy requirements of each chamber of the heart and maintain capture; negative AV/PV Hysteresis and DDT/R Modes Trigger designed to maximize biventricular pacing; and a comprehensive set of atrial fibrillation diagnostics.
Varian Medical Systems (Palo Alto, California) said is introducing the Acuity Brachytherapy Suite, which enables doctors to deliver real-time image-guided brachytherapy treatments. Currently in use at four cancer clinics in the U.S., the suite combines a Varian Acuity imaging system with technology for planning and delivering brachytherapy treatments. Varian's Acuity imager generates 3-D images that can be used both for treatment planning, and for guiding the placement of catheters and needles during brachytherapy procedures. The company said the Acuity Brachytherapy Suite allows doctors to place catheters, acquire images for treatment planning, and deliver a treatment in as little as 30 minutes, without moving the patient room to room.
Thoratec (Pleasanton, California) said data from a newly published study demonstrated improved outcomes of patients implanted with the company's HeartMate XVE Left Ventricular Assist Device (LVAD) for ongoing, permanent support for late-stage heart failure, otherwise known as destination therapy (DT), the company said. That and other findings were reported in an article, "Long-Term 'Destination Therapy' with the HeartMate XVE Left Ventricular Assist Device: Improved Outcomes since the REMATCH Study," published in the May/June edition of Congestive Heart Failure by James Long, MD, and his colleagues. Long is the head of the Utah Artificial Heart Program at LDS Hospital (Salt Lake City). Among the findings were that destination therapy LVAD therapy patients showed marked improvement even over the landmark Randomized Evaluation of Mechanical Assistance Therapy as an Alternative in Congestive Heart Failure (REMATCH) study, with an increase of one year survival to 61% from 52%. With few advances in optimal medical management (OMM) since REMATCH, and continued improvements in LVADs, the paper reported a nearly 150% one-year survival benefit for DT LVAD therapy vs. OMM in this patient population. The findings also demonstrated a 61% decrease in adverse events including an eight-fold reduction in sepsis deaths, the leading cause of mortality in REMATCH. The study attributes these improved outcomes to device enhancements and better patient management practices. The results are the first since the REMATCH study in 2001 that found long-term use of an LVAD improved survival rates and quality of life for heart failure patients compared with those treated with OMM involving maximum drug therapy, diet and exercise. The new study evaluated 42 patients from the four highest-volume centers based on Thoratec's FDA-mandated Destination Therapy Registry. Those centers were LDS Hospital; Advocate Christ Medical (Oaklawn, Illinois); Duke University Medical Center (Durham, North Carolina); and Texas Heart Institute Medical Center (Houston).
Vasomedical (Westbury, New York), a developer of enhanced external counterpulsation therapy (EECP) therapy to treat and manage cardiovascular diseases, said it has been notified by the Centers for Medicare & Medicaid Services Baltimore) that its application requesting consideration for expansion of coverage the therapy has been accepted. The company currently markets the therapy for chronic stable angina and congestive heart failure and said it has been working to expand Medicare coverage for less severe angina and to include coverage for congestive heart failure as a primary indication.