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Medtronic claims a win in European patent row with Edwards Lifesciences

October 30, 2013 10:58 am | by Mass Device | News | Comments

Medtronic is claiming a win in Europe in its patent row with Edwards Lifesciences over their competing transcatheter aortic valve implants. The European Patent Office issued a preliminary, non-binding ruling that the Edwards patent at the center of a...

Medtronic CoreValve U.S. Pivotal Trial Results Reveal Positive Outcomes for Patients

October 29, 2013 2:25 pm | by Medtronic | News | Comments

Medtronic, Inc. today announced the highly anticipated results from the CoreValve U.S. Pivotal Trial, the first U.S. data presented on the Medtronic CoreValve® System. The study of the novel self-expanding device, presented at a late-breaking...

Data: Significant and Sustained Blood Pressure Reduction with Boston Scientific’s Renal Denervation System

October 29, 2013 11:37 am | by PR Newswire | News | Comments

Patients treated with the Boston Scientific Vessix Renal Denervation System experienced a significant and sustained reduction in blood pressure, according to new data presented today at the Transcatheter Cardiovascular Therapeutics (TCT)...

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St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study

October 28, 2013 9:37 pm | by Business Wire | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced positive results for the 23 and 25 mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE Mark Trial. Patients enrolled in the study experienced a...

New Data from St. Jude Medical Study of EnligHTN Renal Denervation System Presented

October 28, 2013 9:22 pm | by Business Wire | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced new results from the EnligHTN I study, confirming safe, rapid and sustained reduction in blood pressure measurements a year and a half post-procedure. Data presented at...

TCT 2013: Higher pacemaker rate marks difference between Medtronic's, Edwards Lifesciences' TAVI devices

October 28, 2013 6:28 pm | by Mass Device | News | Comments

Results from the PRAGMATIC Plus analysis of Edwards Lifesciences' Sapien transcatheter aortic valve implantation system and Medtronic's rivaling CoreValve device found few differences between the devices, with the exception of lower rates of...

TCT 2013: Renal denervation does everything

October 28, 2013 4:35 pm | by Mass Device | News | Comments

Renal denervation may have lost some of its hype over the course of the last year, but researchers are still findings new ways to utilize the technology to target new diseases. Technologies such as Medtronic's Symplicity and St. Jude Medical's...

Covidien to Sell Confluent Surgical Product Line to Integra LifeSciences

October 28, 2013 4:05 pm | by Business Wire | News | Comments

Covidien, a leading global provider of healthcare products, announced today that it has entered into a definitive agreement with Integra LifeSciences Corporation to sell its Confluent Surgical product line. The transaction is expected to close by...

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Boston Scientific Receives CE Mark for Lotus Valve System

October 28, 2013 2:09 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark for the Lotus™ Valve System, the company's advanced transcatheter aortic valve replacement (TAVR) technology.  This key approval offers a unique and effective new treatment alternative for...

FDA Approves GE Brain Imaging Tool for Alzheimer's

October 25, 2013 1:58 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration on Friday approved a radioactive imaging chemical from General Electric to help screen patients for Alzheimer's disease and dementia. The drug, Vizamyl, is an injection of radioactive material designed to...

Abbott's First-In-Class MitraClip Device Available for U.S. Patients

October 25, 2013 9:05 am | by The Associated Press | News | Comments

Abbott today announced that its first-in-class, catheter-based MitraClip therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment...

Stryker Pays $13.3M to Settle Illegal Payment Allegations

October 24, 2013 3:43 pm | by The Associated Press | News | Comments

Medical device maker Stryker will pay the U.S. government $13.3 million to settle allegations it made illegal payments to government employees in five countries. The Securities and Exchange Commission said ...      

Will preemption rescue Medtronic from InFuse lawsuits?

October 24, 2013 1:27 pm | by Mass Device | News | Comments

Medtronic could avoid a major headache if the courts continue to allow the doctrine of preemption in product liability lawsuits filed over its InFuse bone-growth protein, according to Fish & Richardson principal José Sierra. The InFuse bone growth...

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BSD Reports Increasing European Market Penetration by Terumo for Microwave Ablation System

October 24, 2013 9:15 am | by The Associated Press | News | Comments

BSD Medical Corporation today reported that Terumo Europe NV (Terumo), a wholly owned subsidiary of Terumo Corporation, has already introduced the MicroThermX ® Microwave Ablation System (MicroThermX) into the major markets in Europe...   

Layoffs: Boston Scientific to cut up to 1,500 jobs

October 23, 2013 7:38 pm | by Mass Device | News | Comments

In regulatory filings issued late Wednesday evening Boston Scientific announced that it plans to cut up to 1,500 employees from its global workforce before the end of 2015. The cuts are part of the company's plan to streamline operations, including...

Boston Scientific Alair Bronchial Thermoplasty System Approved In China

October 23, 2013 4:30 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received China Food and Drug Administration approval for the Alair® Bronchial Thermoplasty System, an innovative medical device designed to treat severe asthma.  Expected to be available in the China market...

Medtronic Launches New Device to Remove Coronary Thrombus

October 21, 2013 12:01 pm | by Medtronic | News | Comments

With more than a decade of market leadership in medical devices designed to remove thrombus from coronary arteries, Medtronic has announced the U.S. launch of the Export Advance aspiration catheter, which offers ...    

Boston Scientific, Guidant to Pay $30M Settlement

October 18, 2013 1:52 pm | by The Associated Press | News | Comments

The Justice Department says Boston Scientific Corp. and its Guidant subsidiaries will pay $30 million to settle allegations that Guidant knowingly sold defective heart devices that health care facilities implanted in Medicare patients from 2002 to 2005...

GE Healthcare Discloses Button Problem on Machines

October 18, 2013 1:33 pm | by The Associated Press | News | Comments

GE Healthcare is warning physicians that some of its ventilators and anesthesia machines may have unresponsive buttons. The company said the problem affects Engström ventilators and Aespire View, Aisys, and Avance anesthesia machines made...

St. Jude Medical seeks to toss shareholders class action

October 17, 2013 3:59 pm | by Mass Device | News | Comments

St. Jude Medical wants a federal judge in Minnesota to toss a class action lawsuit filed by shareholders after the medical device company's stock took a dive in 2009 when it reduced its guidance. The lawsuit, filed in March 2010, alleges that St. Jude...

Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)

October 17, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The St. Jude Amplatzer Atrial Septal Occluder is a cardiac implant device used in children and adults to treat an abnormal hole between the upper left and right chambers of the heart, known as an atrial septal defect. The metal device is put...

Medtronic can't shake negligence lawsuit over Transvene defibrillator lead

October 16, 2013 3:11 pm | by Mass Device | News | Comments

Medtronic can't use preemption to shake a negligence lawsuit filed over a failed Transvene defibrillator lead, an Indiana appeals court ruled last week. The Court of Appeals of Indiana denied the Fridley, Minn.-based medical device company's bid...

Frost & Sullivan Acclaims GE Healthcare for its Renewed Vision and Focus on Delivering Innovative Radiology Informatics Solutions

October 16, 2013 3:00 pm | by PR Newswire | News | Comments

Based on its recent analysis of the radiology informatics market, Frost & Sullivan recognizes GE Healthcare with the 2013 North American Frost & Sullivan Company of the Year Award. GE Healthcare has remained a leader in the U.S. radiology...

Philips Brings New Anesthesia Product and Patient Monitors to Market

October 16, 2013 12:22 pm | by Philips Healthcare | News | Comments

Expanding its scope of solutions for anesthesiologists, Royal Philips launched three new products: IntelliSave AX700 anesthesia machine and, IntelliVue MX400 and MX450 patient monitors. Delivering ease of use, durability and leading-edge...

Bard seeks to recoup legal costs in dismissed Avaulta bellwether

October 16, 2013 9:57 am | by Mass Device | News | Comments

C.R. Bard wants to recoup its legal costs from a bellwether lawsuit over its Avaulta pelvic mesh that was dismissed last month, asking a federal judge to order the plaintiffs to pony up some $14,000. Judge Joseph Goodwin of the U.S. District Court...

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