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St. Jude Announces Landmark Renal Denervation Study at EuroPCR
St. Jude Medical (St. Paul, MN) announced the launch of a randomized trial that will determine if renal denervation and medication offers additional benefits beyond the reduction of blood pressure in patients with uncontrolled hypertension The study will also evaluate the safety and efficacy of the EnligHTN Multi-Electrode Renal Denervation System for the reduction of cardiovascular events such as heart failure, stroke and heart attack.
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Capsule-Sized Colon Camera Progresses towards FDA Approval
A new clinical study by Given Imaging (Yoqneam, Israel) could help bring the company’s miniaturized colon camera closer to FDA approval. The PillCam Colon is a pill-sized camera that can detect precancerous tumors with an efficacy similar to that of a traditional colonoscopy.
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Terumo Medical Wins Injunction Against Vascular Solutions for Arterial Access Device
Terumo Medical (Somerset, NJ) announced that it won a patent dispute against Vascular Solutions. Following a court ruling, Vascular Solutions can no longer manufacture or sell its R-Band Radial Hemostasis Device. The R-Band device is designed to stop access-point bleeding following arterial access procedures.
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LA Times: Medtech Industry Is "Dishonest" in Device Tax Repeal Efforts
The Los Angeles Times has joined the New York Times in coming out in favor of the 2.3% medical device tax provision of the Affordable Care Act (ACA).
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Study: Philips ClarityIQ Could Halve X-Ray Dose in Cardiac Interventions
Philips' AlluraClarity system equipped with ClarityIQ technology could dramatically reduce patient x-ray exposure for cardiac catheterization procedures, according to clinical trial results released by the company. The study, carried out in 2012 in the Netherlands, showed that the system was able to maintain high image quality needed in image-guided cardiac interventions.
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Galt Medical to Shut Down Texas Manufacturing Facility, Announces 139 Layoffs
Galt Medical Corporation (Garland, Texas) will lay off 139 employees as it shuts down a manufacturing facility in its hometown. Galt, a division of Theragenics, manufactures disposable surgical devices. The closure will take place over the next 24 months, beginning on September 30th.
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Sequester Hits to FDA Could Impact Med Device Approvals
With sequester cuts looming, FDA officials are struggling to find a way to maintain staff and support programs. In particular, the federal agency faces $83 million in cuts as it loses out on some user fees.
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Abbott Receives CE Mark for 48-mm Drug-Eluting Stent
Abbott has received CE Mark approval from the European Union for its Xience Xpedition 48 Everolimus Eluting coronary stent, which is designed for patients suffering from long blockages in blood vessels leading to the heart.
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German Police Seize Nearly 200 Stents from Boston Scientific
OrbusNeich Medical (Hong Kong) reports that 190 stent systems were seized from Boston Scientific’s offices in Germany as a result of a patent dispute between the two companies. The seizure followed a preliminary injunction that bans the sale of Boston Scientific’s stents in Germany. OrbusNeich claims that the injunction and the seizure were needed after Boston Scientific allegedly stated that the stents were not at its German offices.
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Medtronic Smashes Revenue Expectations
Medtronic reported that its fiscal fourth-quarter sales
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