May 2004

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November/December Supplement—The Thoracic Aorta: The Next Frontier in Endovascular Therapy

Meet the Chief Medical Editors
Endovascular Today is proud to have three of the nation’s top endovascular specialists as our Chief Medical Editors. To ensure that our focus encompasses all specialists who participate in endovascular therapies, we have chosen Chief Medical Editors from the fields of interventional cardiology, interventional radiology, and vascular surgery...(meet Takao Ohki, MD, John R. Laird, Jr, MD, and Barry T. Katzen, MD)

Chief Medical Editors' Page
By John R. Laird, Jr, MD
“Don’t hurt my brain. It’s my second favorite organ.”
For patients and health care providers alike, there is no more dreaded illness than stroke, and with good reason. Stroke remains the third leading cause of death in the US and is the most common cause of death as a result of a neurologic disorder. It is estimated that there are more than 700,000 stroke victims per year in this country. Approximately one third of these will die, and one third will be rendered permanently disabled. The health care costs related to stroke are staggering; stroke is the most expensive disease in the US with an estimated annual expenditure of more than $45 billion for the direct and indirect costs related to the care of these patients and lost productivity.
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THIS MONTH'S FEATURES
Types and Etiologies of Strokes
SThe enormous impact of stroke on society is devastating. It is the third leading cause of death, ranking only behind heart disease and cancer, and is the leading cause of disability in adults in the US.1 There are approximately 750,000 new or recurrent strokes and 150,000 deaths from stroke reported every year, which result in approximately $40 billion in annual direct and indirect costs. The number of people affected by stroke is predicted to increase over the next decade due to the aging population. Stroke is divided into two major classifications: ischemic and hemorrhagic. Although the majority of stroke cases are ischemic, hemorrhagic strokes draw equal attention due to less favorable prognosis. Evaluation of stroke type and etiology plays a crucial role in acute management and prevention of recurrent strokes. In this article, we review the various etiologies of both stroke subtypes....(full story)

Acute Stroke Screening: MR or CT?
Acute stroke is the third most common cause of mortality in the US. Eighty-five percent of strokes are ischemic and 15% are hemorrhagic in nature.1 Once the clinical suspicion of stroke arises, prompt confirmation of the diagnosis and the initiation of treatment is critical to minimize the risk of permanent brain injury. CT and/or MRI with or without contrast (CTA, MRA) have become the mainstay of noninvasive testing. Duplex ultrasound, echocardiography, and traditional catheter-based angiography complement the information provided with CT or MR. Given these options, what test(s) should be performed and in what order? The answer may vary according to practice setting.
...(full story

Acute Interventions for Stroke
AThere are 750,000 acute strokes in the US each year, resulting in death and varying levels of permanent neurologic deficit.1 Less than 5% of patients with acute stroke are treated nationally. The remaining untreated patients comprise a wide group whose symptoms are not recognized as strokes, do not present within the time window for treatment, or who are taken to facilities that lack the expertise to treat acute stroke. Some patients improve without treatment. The majority of stroke patients are left to suffer with chronic neurologic problems including speech and language deficits, weakness, paralysis, cognitive impairments, and visual loss.2 The central nervous system is a unique and unforgiving organ. The death of brain cells can result in devastating loss of function, with multiple and varied signs and symptoms complicating diagnosis and treatment.
...(full story)

PFO and Stroke:The Hidden Connection
Stroke is the leading cause of disability and the third leading cause of death in the US. Identifying the causes of neurologic ischemic syndromes is essential to any strategy intended to prevent the catastrophic consequences of cerebral infarction. Figure 1 is a classification scheme depicting that stroke may be ischemic or hemorrhagic at its onset and further diagrams multiple underlying etiologies of the ischemic variety, which collectively represent approximately 85% of all strokes. When such classification methods are applied to large populations of stroke patients, however, the largest single category is usually stroke of unknown cause, more generally labeled as cryptogenic stroke. Although commonly recognized causes such as carotid artery stenosis and atrial fibrillation each generally account for 20% to 25% of stroke etiologies in most series, cryptogenic stroke remains the “diagnosis” in approximately 40% of patients.1,2
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NEWS
Panel Recommends Approval
for Cordis’ CAS System
The FDA Circulatory System Devices Panel on April 21 voted 6 to 5 in favor of recommending approval with conditions for the Cordis Carotid System (Cordis Endovascular, a Johnson & Johnson company, Miami, FL). The Cordis Carotid Stent System consists of the Precise Nitinol Self-Expanding Stent and the AngioGuard Emboli Capture Guidewire. The question before the panel was whether carotid artery stenting (CAS) should be considered “non-inferior” to carotid endarterectomy.
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(full story)

Boston Scientific Releases Cutting Balloon Trial Results
Boston Scientific Corporation (Natick, MA) has announced the results from the Cutting EDGE clinical trial for its Peripheral Cutting Balloon Device. Thomas Vesely, MD, of the Washington University School of Medicine in St. Louis, who presented the data at the 29th Annual Scientific Meeting of the Society of Interventional Radiology, stated that the primary objectives of the Cutting EDGE clinical trial were “to compare the Peripheral Cutting Balloon Device to conventional percutaneous transluminal angioplasty (PTA) in terms of safety, efficacy, and additional characteristics for the treatment of hemodialysis-related stenoses.”...
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Possis to Distribute Angiometrx Metricath Products
Possis Medical, Inc. (Minneapolis, MN), recently signed a 3-year agreement with Angiometrx, Inc. (Vancouver, BC), whereby Possis will act as the exclusive distributor of the Angiometrx Metricath products in the US. The Metricath System is a catheter-based technology that allows cardiologists to measure arterial size during procedures for treatment of coronary artery disease. The system received FDA 510(k) clearance in July 2003.

Guidant Receives CE Mark for Stent for Bifurcated Lesions; Completes Purchase of Bioabsorbable Stent Company
The Multi-Link Frontier Coronary Bifurcation Stent System (Guidant Corporation Indianapolis, IN) was recently given CE Mark approval and launched in Europe, Australia, and New Zealand, with expansion to additional Asian and Middle Eastern countries anticipated soon. The system is designed to treat plaque in coronary arteries at the site of a bifurcation. Thierry Lefèvre, MD, of the Institut Hospitalier Jacques Cartier in Massy, France, was the Principal Investigator of the clinical study that provided safety and performance data for CE Mark approval of the system. “The positive results of the study demonstrate excellent acute and long-term outcomes,” he commented.
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Siemens’ 64-Slice and Open CT Systems Cleared by FDA
The FDA has provided 510(k) clearance for the Somatom Sensation 64 and Somatom Sensation Open systems (Siemens Medical Solutions, Malvern, PA). The Somatom Sensation 64 provides 64-slice submillimeter imaging and a gantry rotation time of 0.37 seconds. Image quality is delivered with an isotropic spatial resolution of 0.4 mm. The Somatom Sensation Open is the first large-bore, open 16-slice system and allows for an 82-centimeter extended field of view. “The Somatom Sensation 64 and Somatom Sensation Open represent huge advancements in CT by revolutionizing patient access and positioning, advancing speed and image quality, and enabling improved clinical workflow and efficiency,” said Richard Haussmann, President, CT Division, Siemens Medical Solutions.

Diomed Alleges Patent Infringement Against Total Vein Solutions
Diomed, Inc. (Andover, MA), has commenced legal action in the US Federal District Court of Massachusetts against Total Vein Solutions, LLC (Houston, TX), seeking injunctive relief and damages for infringement of its patent covering the endovascular laser treatment of varicose veins. Diomed has previously filed similar actions against AngioDynamics, Inc. (Queensbury, NY), and Vascular Solutions, Inc. (Minneapolis, MN).
....(full story)

Cook Begins TAA Trial in US
The first US placement of the Zenith TX2 Thoracic TAA Endovascular Graft has been completed as part of the device’s pivotal US clinical trial sponsored by Cook Incorporated (Bloomington, IN). According to the study’s principal investigator, Jon Matsumura, MD, Associate Professor of Surgery, Northwestern University Feinberg School of Medicine, the clinical trial will include 220 patients at up to 35 US medical institutions. “The enrollment of the first patient in this trial is an important achievement,” Dr. Matsumura stated.
....(full story)

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