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Positive Outcomes for CoreValve Patients Treated via Alternative Access Routes

April 30, 2014 10:19 am | by Medtronic Inc. | News | Comments

Medtronic, Inc. today revealed new data demonstrating positive outcomes for extreme risk patients with severe aortic stenosis who were treated with the CoreValve System via alternative access approaches. The compelling data were unveiled...

Medtronic’s Sutureless Heart Valve First to Show Five-Year Safety and Efficacy Outcomes

April 29, 2014 10:13 am | by Medtronic | News | Comments

Medtronic, Inc. today announced five-year follow-up data demonstrating the safety and performance of the Medtronic 3f Enable Aortic Bioprosthesis - the world's first commercially available sutureless tissue heart valve.  The longest follow...

As Stryker Hip Lawsuits Mount, Company Details Costs Associated with Stryker Rejuvenate, ABG II Modular Hip Stem Recall

April 28, 2014 12:33 pm | by The Associated Press | News | Comments

As hundreds of Stryker hip lawsuits continue to move forward in courts around the country, Bernstein Liebhard LLP notes that Stryker recently released its 2014 first quarter earnings report, which among other things, details costs associated...

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J&J: Business Doing Well on New Product Approvals

April 24, 2014 2:32 pm | by Linda A. Johnson - AP Business Writer | News | Comments

Johnson & Johnson CEO Alex Gorsky said Thursday that all three of its business segments are doing well and made significant medical advances last year. Gorsky told about 1,650 shareholders at J&J's annual meeting that the company is...

BD Launches New Point-of-Care System for HIV/AIDS Patients

April 24, 2014 9:26 am | by PR Newswire | News | Comments

BD Biosciences, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the launch of the BD FACSPresto Near Patient CD4 Counter system that provides absolute and percentage results of...

Scripps Is First in Region to Implant Wireless Cardiac Pacemaker

April 23, 2014 3:39 pm | by PR Newswire | News | Comments

Scripps Health became the first health care provider in Southern California to implant the investigational Nanostim™ leadless pacemaker, the world's first wireless pacemaker totally implanted in the heart, as part of the Leadless II Clinical...

Boston Scientific Begins Clinical Trial for Pacing Leads

April 23, 2014 9:24 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has conducted the first implant in the clinical trial of the next generation ACUITY X4 left-ventricular (LV) pacing leads and RELIANCE 4-FRONT defibrillation (ICD) leads. The clinical trial is designed to establish...

First U.S. Implant of ICD System that Allows Full-Body MRI Scans

April 22, 2014 10:22 am | by Medtronic | News | Comments

Medtronic has announced the first U.S. implant of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) System, following U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application...

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Federal Appeals Court Agrees to Medtronic Request to Postpone Injunction

April 22, 2014 9:18 am | by Medtronic | News | Comments

The Federal Circuit Court of Appeals today granted a request from Medtronic, Inc. to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System in the United States. This means the...

Plates Give Surgeon Customized Design

April 21, 2014 10:53 am | by DePuy Synthes CMF | News | Comments

DePuy Synthes CMF (Craniomaxillofacial), a leader in skeletal and soft tissue repair and reconstruction and part of the DePuy Synthes Companies of Johnson & Johnson, announced the launch of Patient Specific Plates for Mandible (PSPM)...

MGS Purchases Hospira Molding Facility

April 21, 2014 10:27 am | by MGS Mfg. Group | News | Comments

MGS Mfg. Group, headquartered in Germantown, Wisconsin, announced it has purchased Hospira’s Buffalo, New York injection molding facility. The formal declaration was made to facility employees on Monday, April 14, 2014 by members of Hospira...

Endurant AAA Stent Graft Continues Exceptional Long-Term Performance

April 21, 2014 10:18 am | by Medtronic Inc. | News | Comments

The Endurant AAA stent graft system from Medtronic, Inc. continues to demonstrate exceptional long-term performance in the endovascular treatment of abdominal aortic aneurysms, according to new clinical data presented for the first time...

Court Agrees to an Expedited Appeal in CoreValve System

April 21, 2014 9:13 am | by Medtronic Inc. | News | Comments

Medtronic, Inc. today issued an updated statement on the recent ruling by Federal District Court of Delaware. The ruling granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic from selling or offering...

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Heart Device Lawsuits Continue Against St. Jude Over Defective Riata Lead Wires

April 18, 2014 2:38 pm | by The Associated Press | News | Comments

The Torkzadeh Law Firm (TorkLaw) is now representing over 100 clients against St. Jude Medical, Inc. related to the recalled St. Jude Medical, Inc. Riata leads. In November 2011, the FDA issued a Class 1 recall of the St. Jude Medical Riata...

FDA Approval for New Defibrillators and Heart Failure Devices

April 16, 2014 10:17 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the DYNAGEN MINI and INOGEN MINI ICDs, as well as...

Preliminary Injunction Against Guidezilla Catheter Vacated by Federal Circuit

April 16, 2014 10:09 am | by Vascular Solutions | News | Comments

Vascular Solutions, Inc. announced that a three judge panel of the U.S. Court of Appeals for the Federal Circuit today vacated the preliminary injunction that was previously issued by the District Court for the District of Minnesota effective...

Imaging’s Role in Cancer Research

April 14, 2014 2:08 pm | by Gregory Sorensen, MD, President and CEO, Siemens Healthcare North America | Blogs | Comments

Anyone who hears the words, “You have cancer,” wants to hear next that they will survive.  Thankfully today, more patients are indeed beating the disease.  Medical imaging is an integral part of many survivors’ personal victories over the disease...

Abbott Receives 510(k) for Test to Help Diagnose Diabetes

April 14, 2014 11:31 am | by Abbott | News | Comments

Abbott announced today that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test - which can aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease - has received 510(k) clearance...

Covidien Gets FDA 510(k) Clearance for Kangaroo Feeding Tube with IRIS Technology

April 14, 2014 11:20 am | by Covidien | News | Comments

Covidien today announced U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing...

Medtronic to Appeal Federal District Court Ruling

April 14, 2014 11:07 am | by Medtronic Inc. | News | Comments

The Federal District Court of Delaware today granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic, Inc. from selling or offering to sell its CoreValve System in the United States. Today's ruling has...

Opportunities and Challenges of Doing Business in Companion Diagnostics

April 14, 2014 9:56 am | by Richard Park, Contributing Editor | Blogs | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some of the major IVD manufacturers to share their thoughts and opinions on the current opportunities and challenges in companion...  

Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device

April 11, 2014 10:14 am | by Covidien | News | Comments

Covidien plc has announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied...

First Patient Enrolled in Clinical Registry Assessing Boston Scientific Vercise Deep Brain Stimulation System in Patients with Parkinson's Disease

April 11, 2014 10:07 am | by PR Newswire | News | Comments

Boston Scientific Corporation has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise™ Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. DBS is a surgical...

First Patient in U.S. to Receive MRI Scan in Clinical Study of MRI-Compatible Pacemaker

April 10, 2014 8:36 pm | by PR Newswire | News | Comments

Providence Saint Joseph Medical Center is the first hospital in the nation to conduct an MRI scan of a patient implanted with a new MRI-compatible pacemaker – a breakthrough because metal implants often exclude patients from this imaging...

Medtronic CRT Devices Now Approved to Treat Patients with AV Block and Reduced Heart Function

April 10, 2014 7:33 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D)...

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