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Kidney failure patients on dialysis derive long-term benefit from the minimally invasive placement of a stent that improves the function of dialysis access grafts, according to 12-month clinical trial results being presented at the Society of Interventional Radiology's 38th Annual Scientific Meeting in New Orleans.

Home April 16, 2013
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Accumetrics Inc. announced an expansion in the intended use for the CE marked VerifyNow P2Y12 Test. Physicians can now use the test results to assess whether a patient may be at greater risk for both bleeding or ischemic events, as an aid to manage therapeutic treatment decisions and accurately assess the antiplatelet effect from P2Y12 inhibitors (such as clopidogrel, prasugrel and ticagrelor).

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Technology

Maquet Cardiovascular LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European CE mark approval for its new Air-Band Radial Compression Device. Indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. Air-Band will be commercially available in the European Union later this month and in the United States in April.

Home April 16, 2013
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Improving patient safety while offering clinicians a more complete picture during interventional procedures, Toshiba America Medical Systems Inc. will showcase Spot Fluoroscopy for its Infinix-i vascular X-ray systems at this year’s Society of Interventional Radiology (SIR) 2013 annual meeting.

Home April 15, 2013
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Tyrx announced the first implantation of its new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Quebec Heart and Lung Institute in Quebec City, Canada by Dr. François Philippon. Tyrx announced on Jan. 31, 2013 that it had received a license from Health Canada to market its AigisRx R Fully Resorbable technology.

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Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver Vena Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. This disease is characterized by leg pain, throbbing, swelling and skin discoloration in the legs.

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Nanomix Inc. has initiated clinical testing in the United States to evaluate the omega-3 cardiac panel. The panel quantitatively tests whole blood specimens for levels of cardiac troponin I (cTnI), myoglobin and H-FABP, biomarkers often used as an aid in the diagnosis of myocardial infarction (MI). The initial testing will be conducted with approximately 170 normally healthy subjects and will provide baseline performance information that will form the basis of future registration clinical studies.

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At Medanta Hospital in Gurgaon, India, five EchoBox devices were connected to five GE Vivid ultrasound systems, streaming live echo images over the web to experienced sonographers located in the United States.

Home April 15, 2013
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The Massachusetts General Hospital officially announced the launch of the Mass General Institute for Heart, Vascular and Stroke Care, one of the only institutes in the world to integrate cardiovascular and cerebrovascular care.

Home April 12, 2013
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The U.S. Food and Drug Administration (FDA) issued a second complete response letter regarding a supplemental new drug application (sNDA) for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS). Janssen Research and Development LLC is evaluating the letter and will respond to the agency's questions.

Home April 12, 2013
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Colibri Heart Valve LLC has successfully completed the first clinical use of the company's proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI) system is the world's first and only low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use, TAVI system. These advantages are designed to reduce delivery profile along with a reduction in preparation and insertion time, which are not available in any other device, either currently available or in known development.

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A research study of more than 600 black patients with uncontrolled hypertension found that less than half were prescribed a diuretic drug with proven benefit that costs just pennies a day, report researchers at Weill Cornell Medical College and the Visiting Nurse Service of New York's (VNSNY) Center for Home Care Policy and Research. The researchers say these new findings should be taken as a serious wake-up call for physicians who treat black patients with hypertension.

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The Society for Cardiovascular Angiography and Interventions (SCAI) reports on the “Ten Do’s and Don’ts for Improving Documentation in the Catheterization (Cath) Lab” based on studies by the Accreditation for Cardiovascular Excellence (ACE).

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CardioLogical Solutions, formed by the recent merger of Emboline and VasoStitch, has been issued an additional patent for its family of aortic embolic protection devices that are designed to prevent stroke and other ischemic complications.

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Lantheus Medical Imaging has entered into a new agreement with Fujifilm RI Pharma (FRI) to license and distribute Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) and Neurolite (Kit for the Preparation of Technetium Tc99m Bicisate for Injection) in Japan.

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