Cardiovascular
St. Jude Medical Announces Launch of 3D Vessel Reconstruction Technology in Japan
March 11, 2013 8:00 am | by The Associated Press | News | CommentsST. PAUL, Minn.--(BUSINESS WIRE)--Mar 11, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of its ILUMIEN ™ OPTIS ™ System, a next-generation technology designed to help physicians make personalized stenting decisions based on each patient’s...
Gore Launches Lower Profile GORE® EXCLUDER® AAA Endoprosthesis Contralateral Leg Components in US and Europe
March 11, 2013 4:00 am | by The Associated Press | News | CommentsFLAGSTAFF, Ariz.--(BUSINESS WIRE)--Mar 11, 2013--W. L. Gore & Associates, Inc. (Gore) has announced the US and European launch of lower profile contralateral leg components for the GORE® EXCLUDER® AAA Endoprosthesis used to treat abdominal aortic aneurysms (AAAs). The reduced profile sizes...
Early results "encouraging" for Edwards' redesigned Sapien XT valve
March 10, 2013 12:47 pm | by Mass Device | News | CommentsMedical device maker Edwards Lifesciences unveiled results from the 1st randomized study of its Sapien XT transcatheter aortic valve replacement system, reporting non-significant improvements in safety when compared with the original Sapien system. The PARTNER II trial's Cohort B was designed to demonstrate that the Sapien XT was at least non-inferior to Sapien classic...
New Data Reinforce Significant Blood Pressure Reduction Sustained to Two Years Using the Symplicity(TM) Renal Denervation System
March 10, 2013 12:18 pm | by The Associated Press | News | CommentsMedtronic, Inc. announced 24-month data from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation. Presented for the first time today at the 62nd Annual Scientific Session of the American College of Cardiology, the data show patients treated with the Symplicity renal denervation system (n=66) sustained a significant drop in blood pressure.
Abbott's Minimally Invasive MitraClip® System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery
March 10, 2013 11:30 am | by PR Newswire | News | CommentsSAN FRANCISCO, March 10, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip® System for the treatment of mitral...
The Boston Scientific PROMUS Element™ Platinum Chromium Stent Demonstrates Continued Low Event Rates Through Three Years
March 10, 2013 11:30 am | by PR Newswire | News | CommentsNATICK, Mass., March 10, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reported clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Coronary...
Boston Scientific Apologizes for Embargo Breach that Got Its Watchman Trial Pulled from Conference
March 9, 2013 11:16 pm | by Mass Device | News | CommentsAmerican College of Cardiology conference organizers cancel the highly anticipated presentation of preliminary results from Boston Scientific's PREVAIL study after the company leaks the data ahead of time. Boston Scientific publishes the slides that would have been presented.
Do Hybrid Cars Interfere With Cardiac Implants? Apparently Not, Study Finds
March 9, 2013 7:40 pm | by Mass Device | News | CommentsMayo 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 | CommentsBoston 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 | CommentsBoston 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.
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...
