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With Medtronic Resolute Stent, Interrupting Dual Antiplatelet Therapy After One Month Showed No Increased Safety Risk in Robust Analysis

March 11, 2013 12:18 pm | by The Associated Press | News | Comments

Cardiologists at ACC.13 learned today that patients with coronary artery disease who received a Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) as participants in one of several clinical studies and interrupted or discontinued their dual antiplatelet therapy after one month of the implant procedure showed no increased safety risk through one year of follow-up.

St. Jude Medical Announces Launch of 3D Vessel Reconstruction Technology in Japan

March 11, 2013 8:00 am | by The Associated Press | News | Comments

ST. 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...

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 | Comments

Medtronic, 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.

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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 | Comments

SAN 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 | Comments

NATICK, 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 | Comments

American 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.

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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ACC13: Boston Scientific's PREVAIL clinical trial presentation canceled

March 9, 2013 11:54 am | by Mass Device | News | Comments

Medical device giant Boston Scientific (NYSE:BSX) will not present its highly anticipated PREVAIL clinical trial results at the American College of Cardiology conference as planned this morning after the presentation was canceled when the company leaked the data ahead of time.

Jury Deems J&J's Depuy ASR XL Hip Implant Defective in Design, Orders $8.3M in Damages

March 8, 2013 2:20 pm | by Mass Device | News | Comments

A California jury ruled against Johnson & Johnson and its DePuy subsidiary in finding that the company's ASR XL metal-on-metal hip implant was defectively designed. The decision marks the highly anticipated close of the 1st of more than 10,750 such lawsuits against J&J.

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...

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.

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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...

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...

Boston Scientific hesitates to release full safety results for Watchman heart implant

March 6, 2013 1:27 pm | by Mass Device | News | Comments

Officials at Boston Scientific (NYSE:BSX) announced this week that they would reveal only limited patient safety results when they present data from a clinical trial of the Watchman stroke prevention implant at the American College of Cardiology conference this week.

Premier Strikes CRM Deals with Medtronic, Boston Scientific, Others

March 6, 2013 12:45 pm | by Mass Device | News | Comments

Group purchasing organization Premier Healthcare Alliance struck a deal with 4 major players in the cardiac device market for several cardiac rhythm management device portfolios. Boston Scientific, Biotronik, Medtronic, and Oscor have all agreed to make certain CRM devices available to customers in the Premier network.

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...

Bard to Present at Barclays Global Healthcare Conference

March 6, 2013 10:30 am | by The Associated Press | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--Mar 6, 2013--C. R. Bard, Inc. (NYSE: BCR) today announced that it will present at the Barclays Global Healthcare Conference in Miami, Florida on March 13, 2013. Timothy M. Ring, chairman and chief executive officer, will discuss the Company in a presentation...

MicroVention's New Manufacturing Plant Facility In Costa Rica Celebrates Grand Opening With Inaugural Plant Ceremony

March 6, 2013 10:01 am | by The Associated Press | News | Comments

MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced that its new manufacturing facility in San Jose, Costa Rica is now open.  The Company also held a Grand Opening Ceremony today to commemorate this exciting new venture for MicroVention.  The new plant represents ...

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.

GE Healthcare Survey Reveals Many Healthcare Organizations Not Prepared for Capacity Management Challenges

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

NEW ORLEANS--(BUSINESS WIRE)--Mar 5, 2013--GE Healthcare Performance Solutions, a unit of General Electric Corp. (NYSE: GE), today announced the results of a new survey that shows U.S. healthcare organizations may not be prepared to tackle the serious capacity and patient flow challenges ahead....

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.

Closing Arguments in DePuy ASR Lawsuit

March 1, 2013 11:51 am | by Mass Device | News | Comments

Johnson & Johnson's DePuy Orthopaedics unit played "Russian roulette" with its ASR metal-on-metal hip implant, a jury heard yesterday in the closing arguments of a high-profile personal injury lawsuit; J&J denies the allegations, saying the plaintiff's ills were due to other medical problems.

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