Technology | Dave Fornell

The U.S. Food and Drug Administration (FDA) granted U.S. market approval for Medtronic’s self-expanding transcatheter aortic valve replacement (TAVR) CoreValve System. It is the first self-expanding TAVR valve to be approved in the United States and the second TAVR valve to achieve FDA approval.

Home January 17, 2014
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sorin perceval s heart valve repair cardiovascular surgery
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Cardiothoracic and Vascular Surgeons (CTVS) is the first practice in Texas to implant a Sorin Perceval S self-anchoring aortic heart valve as part of a new clinical trial.

Home January 17, 2014
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Providers report that despite vendor efforts, clinical decision support (CDS) reference products are still not integrated enough to deliver the strategic direction providers are looking for.

Home January 16, 2014
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Medtronic, corevalve, edwards, litigation, TAVR, TAVI
Feature | Dave Fornell

In a move that calls into question the future of transcatheter valve competition in the United States, a jury in the Federal District Court of Delaware decided Jan. 15 the Medtronic CoreValve infringes on transcatheter device patents held by Edwards Lifesciences Corp. Medtronic said it intends to appeal the decision.

Home January 15, 2014
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A new “fluid biopsy” technique that could identify patients at high risk of a heart attack by identifying specific cells as markers in the bloodstream has been developed by a group of researchers at The Scripps Research Institute (TSRI).

Home January 15, 2014
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mri systems clinical trial study university pennsylvania creatine CEST map
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A new magnetic resonance imaging (MRI) method to map creatine at higher resolutions in the heart may help clinicians and scientists find abnormalities and disorders earlier than traditional diagnostic methods.

Home January 15, 2014
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Amaranth Medical announced the closing of an equity investment by Boston Scientific Corp.

Home January 14, 2014
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heart valve repair clinical trial study edwards lifesciences sapien 3
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Edwards Lifesciences Corp. announced that it received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of the Sapien 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis.

Home January 14, 2014
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MediValve Ltd. announced that it has received clearance of a Pre-Marketing Notification Application (510(k)) from the U.S. Food and Drug Administration (FDA) for its acWire Guidewire.

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A clinical trial found that Xa inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF).

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CVRx Inc. announced findings from a health-economic analysis published in the Journal of Hypertension that indicates Barostim Therapy is a cost-effective treatment option for patients with drug-resistant hypertension.

Home January 10, 2014
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In a preclinical study, researchers from Boston Children's Hospital, BWH and Massachusetts Institute of Technology (MIT) developed a bio-inspired adhesive that could rapidly attach biodegradable patches inside a beating heart in the exact place where congenital holes in the heart occur.

Home January 09, 2014
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Medtronic, symplicity, renal denervation
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Medtronic Inc. announced its U.S. pivotal trial for its Symplicity renal denervation system to treat resistant hypertension, the SYMPLICITY HTN-3 trial, failed to meet its primary efficacy endpoint. The trial met its primary safety endpoint, and the trial's Data Safety Monitoring Board (DSMB) concluded that there were no safety concerns in the study.

Home January 09, 2014
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SunTech Medical, a Halma company that provides noninvasive blood pressure monitoring products and technologies, has signed a cooperation contract with Corscience GmbH and Co. KG, medical engineering company that specializes in cardiovascular applications, Erlangen, Germany.

Home January 09, 2014
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topera 3-d 3d mapping system firmap rhythmview EP lab mapping fibrillation
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Topera Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest generation of its 3D Mapping System.

Home January 09, 2014
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