Cardiovascular
Presentation of Preliminary Results From Boston Scientific PREVAIL Clinical Trial Now Available
March 9, 2013 9:29 am | by Bio-Medicine.Org | News | CommentsBoston 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 | CommentsPRINCETON, 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 | CommentsBoston 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 | CommentsST. 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 | CommentsKIRKLAND, 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®....
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 | CommentsCellAegis 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 | CommentsFederal 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 | CommentsMedtronic, 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 | CommentsREDWOOD 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 | CommentsSAN 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...
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 | CommentsANDOVER, 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 | CommentsFor 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 | CommentsNATICK, 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 | CommentsWAUKESHA, 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 | CommentsMedtronic, 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 | CommentsMedtronic 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 | CommentsMedtronic, 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 | CommentsCircuLite®, 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 | CommentsMercator 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 | CommentsST. 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 | CommentsOf 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 | CommentsPumped 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.
Capital BlueCross Announces Designation of IPG as their Implantable Device Benefit Management Partner
March 4, 2013 8:00 am | by The Associated Press | News | CommentsATLANTA--(BUSINESS WIRE)--Mar 4, 2013--Capital BlueCross and IPG, the leading nationwide provider of implantable Device Benefit Management™ (DBM) solutions, are pleased to announce an exclusive agreement to provide a comprehensive DBM program to participating facilities in Capital BlueCross’...
FDA Warns Doc on CoreValve Heart Implant Trial Record-Keeping Issues
March 1, 2013 1:51 pm | by Mass Device | News | CommentsHard on the heels of a regulatory win in Europe for one of its heart implants, Medtronic got some bad news from the FDA regarding another. Yesterday Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for its next-generation Engager transcatheter aortic valve implant.
Consumer Information on: VASCADE Vascular Closure System (VCS) - P120016
March 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | CommentsThe VASCADE Vascular Closure System (VCS) is designed to close a puncture site in the major artery of the thigh (femoral artery). The system is comprised of a delivery device and a collagen patch. Over time, the collagen patch breaks down and is...
