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Do Hybrid Cars Interfere With Cardiac Implants? Apparently Not, Study Finds

March 9, 2013 7:40 pm | by Mass Device | News | Comments

Mayo Clinic researchers examine the interaction between implantable cardiac devices and the electromagnetic interference generated by hybrid-electric vehicles, finding no reason for concern. In the 1st study of its kind to examine the interaction between hybrid cars and implantable cardiac devices, researchers found that the electromagnetic waves generated by the green vehicles don't pose a threat.

The Boston Scientific Watchman@ Device Continues To Demonstrate Positive Clinical Outcomes For Patients With Atrial Fibrillation

March 9, 2013 2:24 pm | by The Associated Press | News | Comments

Boston Scientific Corporation (NYSE: BSX) reports preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The PREVAIL trial evaluates safety and efficacy of the WATCHMAN@ Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial...

Boston Scientific's Watchman Heart Implant Shows Improved Safety Profile in Preliminary Results

March 9, 2013 12:12 pm | by Mass Device | News | Comments

Boston Scientific hopes to reassure FDA regulators about the safety and efficacy of its Watchman stroke prevention implant with results from its PREVAIL study, the presentation for which was pulled from the lineup at the American College of Cardiology conference in San Francisco today.

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Presentation of Preliminary Results From Boston Scientific PREVAIL Clinical Trial Now Available

March 9, 2013 9:29 am | by Bio-Medicine.Org | News | Comments

Boston Scientific Corporation (NYSE: BSX ) announces the preliminary analysis of the PREVAIL clinical trial data is now available on TCTMD.  PREVAIL evaluates the safety and efficacy of the WATCHMAN® Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial...

STENTYS Self-Apposing® Stent Demonstrates Lowest Mortality Rate Among Large Heart Attack Trials

March 9, 2013 9:00 am | by The Associated Press | News | Comments

PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--Mar 9, 2013--STENTYS (FR0010949404 – STNT), a medical technology company commercializing in Europe the world's first and only Self-Apposing ® Stent to treat acute myocardial infarction (AMI), announced today one-year results of the APPOSITION III...

Report: Boston Scientific Issues Alert on Its Lead-Free S-ICD Defibrillator

March 8, 2013 1:43 pm | by Mass Device | News | Comments

Boston Scientific recently issued a warning on its lead-free implantable defibrillators over concerns that a fuse malfunction could prevent the devices from delivering life-savings shocks. The company has received reports of four instances in which a fuse inside the subcutaneous ICD was activated inappropriately.

St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation

March 8, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER ™ Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER ™ Cardiac Plug...

Cardiac Dimensions® Completes Patient Enrollment in TITAN II Clinical Trial

March 8, 2013 8:00 am | by PR Newswire | News | Comments

KIRKLAND, Wash., March 8, 2013 /PRNewswire/ -- Cardiac Dimensions®, Inc. today announced that it has completed enrollment in its TITAN II clinical trial, a follow-up to the landmark TITAN clinical trial of the Company's CARILLON® Mitral Contour System®....

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CellAegis Devices Receives Marketing Authorization from Health Canada for the autoRICT Device to Provide Non-Invasive Remote Ischemic Conditioning (RIC)

March 7, 2013 12:34 pm | by The Associated Press | News | Comments

CellAegis Devices, Inc. announced today that it has received marketing authorization from Health Canada that allows for the commercial introduction in Canada of the Company's autoRICT Device for Remote Ischemic Conditioning (RIC). Health Canada has granted a Medical Device Class III license...

FDA Considers Patent Extension for Edwards' Sapien TAVI Heart Implant

March 7, 2013 10:29 am | by Mass Device | News | Comments

Federal healthcare regulators review Edwards Lifesciences request for an extension to patents for its Sapien transcatheter aortic valve implantation system, the only such device on the U.S. market. Drawings from Edwards Lifesciences' U.S. Patent No. 5,411,552.

Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160 mm Hg

March 7, 2013 10:19 am | by The Associated Press | News | Comments

Medtronic, announced today that the company has submitted an Investigational Device Exemption to the U.S. FDA to study the Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg despite treatment with three or more anti-hypertensive medications of different classes.

Avinger Announces Primary Investigators for Upcoming VISION Trial

March 7, 2013 10:00 am | by The Associated Press | News | Comments

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar 7, 2013--Avinger, Inc., designer of therapeutic devices incorporating intravascular imaging, and pioneer of the lumivascular approach to treating vascular disease, announces the designation of the primary investigators for its upcoming global VISION...

First U.S. Installation of Centricity Cardio Enterprise Complete

March 7, 2013 9:09 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 7, 2013--GE Healthcare today announced the first U.S. installation of its Centricity™ Cardio Enterprise solution at Oklahoma State University Medical Center. This robust IT solution supports GE Healthcare’s enterprise imaging strategy by offering cardiologists a...

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Philips Healthcare and Infraredx Introduce Solution to Enable Seamless Integration of TVC Imaging System with Philips’ Allura Xper Systems

March 7, 2013 8:30 am | by The Associated Press | News | Comments

ANDOVER, Mass. & BURLINGTON, Mass.--(BUSINESS WIRE)--Mar 7, 2013--Royal Philips Electronics (NYSE: PHG, AEX: PHI) and Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced the availability...

'Disappearing Stent is a Dream Come True' - World Leaders at India Live Cardiology Conference 2013

March 7, 2013 6:13 am | by PR Newswire | News | Comments

For its ability to unblock and then make arteries return to natural form, the recently launched bioresorbable vascular scaffold (BVS and also known as disappearing stent) is being hailed as the 4th revolution in management of coronary artery disease at India's biggest conference on interventional cardiology.

Boston Scientific Updates PREVAIL Late Breaking Clinical Trials Presentation

March 6, 2013 4:34 pm | by PR Newswire | News | Comments

NATICK, Mass., March 6, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) PREVAIL clinical trial results will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology, and will include all...

Cardiac Science Celebrates 100-Year Anniversary

March 6, 2013 2:55 pm | by PR Newswire | News | Comments

WAUKESHA, Wis., March 6, 2013 /PRNewswire/ -- Cardiac Science Corporation, an Opto Circuits group company and a global leader in automated external defibrillators (AEDs) and diagnostic cardiac monitoring devices, announced the start of its 100-year anniversary celebration with a...

Symplicity(TM) Renal Denervation System One of First Devices Accepted to Participate in Concurrent Review for Joint FDA Premarket Approval and Medicare National Coverage Determination

March 6, 2013 12:18 pm | by The Associated Press | News | Comments

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have accepted the inclusion of the Symplicity(TM) renal denervation system for treatment-resistant hypertension in their parallel review program...

Medtronic Announces CE Mark and European Launch of Attain Performa Portfolio of Quadripolar Leads

March 5, 2013 10:06 am | by The Associated Press | News | Comments

Medtronic announced it has received a CE Mark and will begin the European launch of the Attain Performa portfolio of quadripolar leads. Paired with Medtronic Viva/Brava Quad cardiac resynchronization therapy defibrillators, Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies...

Medtronic Announces CE Mark and European Launch of Attain Performa® Portfolio of Quadripolar Leads

March 5, 2013 10:06 am | by The Associated Press | News | Comments

Medtronic, Inc. announced it has received CE (Conformité Européenne) Mark and will begin the European launch of the Attain Performa® portfolio of quadripolar leads. Paired with Medtronic Viva®/Brava® Quad cardiac resynchronization therapy defibrillators, Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies.

CircuLite® Receives Conditional IDE Approval for SYNERGY® Circulatory Support System Feasibility Trial

March 5, 2013 9:00 am | by The Associated Press | News | Comments

CircuLite®, Inc. today announced that it has received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the SYNERGY® Circulatory Support System, a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.

Peripheral Artery Disease: Mercator MedSystems Wins CE Mark for Catheter Systems

March 4, 2013 12:12 pm | by Mass Device | News | Comments

Mercator MedSystems touted European regulatory approvals for a pair of micro-infusion catheters for the treatment of peripheral artery disease. The San Leandro, Calif.-based medical device company received CE Mark approval in the European Union to market its Cricket and Bullfrog catheters, which are designed to inject therapeutic agents safely through blood vessel walls into deep tissues.

Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference

March 4, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn., & SAN FRANCISCO--(BUSINESS WIRE)--Mar 4, 2013--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present data from its ORBIT II study of coronary artery disease at the 2013 American College of Cardiology (ACC) conference in San Francisco, Mar. 9–11, 2013. This marks the...

Medtronic Approved to Update Resolute Integrity Stent’s CE Mark Labeling on Dual Antiplatelet Therapy

March 4, 2013 10:27 am | by Medtronic | News | Comments

Of relevance to the clinical practice of interventional cardiology, Medtronic announced that it has received regulatory approval to update the CE mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy, the shortest minimum duration referenced on the label for any device of its kind.

Asian Portable Heart Monitor Demand Drives Expansion of Global Diagnostic Cardiology Device Market

March 4, 2013 10:08 am | by IMS Research | News | Comments

Pumped up by rising demand in Asia for portable heart monitors, the global market for diagnostic cardiology devices is set to expand by 12 percent from 2011 to 2016, according a new report from IMS Research, now part of IHS. Worldwide market revenue for diagnostic cardiology devices is projected to rise to $882 million in 2016, up from $786 million in 2011.

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