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St. Jude Medical Receives CE Mark Approval of MultiPoint Pacing CRT-D

June 24, 2013 8:00 am | by Business Wire | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP ™ cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s first-to-market Quadripolar Pacing System, the Quadra Assura MP CRT-D features MultiPoint ™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart.

High-Voltage Devices from St. Jude Medical Get FDA Approval

June 18, 2013 1:46 pm | by St. Jude Medical | News | Comments

St. Jude Medical (NYSE:STJ) has announced U.S. Food and Drug Administration (FDA) approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.

Approval Of Boston Scientific's Watchman Device Will Support Rapid Growth In The Global Heart Defect Closure Device Market

June 12, 2013 8:00 am | by The Associated Press | News | Comments

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's WATCHMAN device will drive rapid growth in the market for global heart defect closure devices. ...

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St. Jude Medical Announces FDA Approval of High-Voltage Devices with New Safety Features

June 11, 2013 4:05 pm | by Business Wire | News | Comments

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.

St. Jude Medical Signs Equity Investment and Option to Purchase Agreement with Spinal Modulation

June 7, 2013 11:01 am | by Business Wire | News | Comments

St. Jude Medical, Inc., a global medical device company, and privately-held Spinal Modulation, Inc., today announced that they have entered into a series of agreements under which St. Jude Medical made a $40 million equity investment in Spinal Modulation, a company that has developed an innovative neuromodulation therapy that provides a new pain management option for patients with chronic, intractable pain.

St. Jude Medical Initiates First US Clinical Study of the EnligHTN Renal Denervation System for Drug-Resistant High Blood Pressure

June 4, 2013 8:00 am | by Business Wire | News | Comments

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN ™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology

May 23, 2013 4:15 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 23, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN ™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after...

St. Jude Medical EnligHTNment Study Highlighted at EuroPCR During Trials That May Change Clinical Practice Session

May 21, 2013 9:52 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 21, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and...

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St. Jude Medical Announces First Patient Enrollment in EnligHTN III Renal Denervation Study of Next-Generation EnligHTN System

May 14, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 14, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced enrollment of the first patient in the EnligHTN III trial. This study will evaluate the safety and performance of the new second-generation EnligHTN ™ Renal...

St. Jude Medical Announces Results from Independent Analysis of Optim-Insulated Defibrillation Leads in Late-Breaking Clinical Trial Session at Heart Rhythm 2013

May 9, 2013 1:55 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 9, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the Population Health Research Institute (PHRI), an academic health science research institute, has conducted a further independent analysis of data received from...

St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices

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

ST. PAUL, Minn.--(BUSINESS WIRE)--May 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy...

St. Jude Medical Enrolls First Patient in Next-Generation Quadra Study

May 3, 2013 9:46 am | by Business Wire | News | Comments

St. Jude Medical, a global medical device company, today announced first enrollment of its MultiPoint Pacing clinical study to build upon its first- to-market Quadripolar Pacing System. Patients will be implanted with the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) and Quartet lead to assess pacing in multiple locations in the heart.

Patients Slap St. Jude Medical with Lawsuits over Recalled Riata Heart Wires

April 5, 2013 2:27 pm | by Mass Device | News | Comments

St. Jude Medical was slapped with multiple lawsuits in California courts yesterday over its recalled Riata defibrillator lead, alleging that the heart wires were defective and led to injuries or death for more than 30 patients. The lawsuits generally accuse St. Jude of violating both state and federal requirements for reporting issues with medical devices...

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Will Another Durata Failure Report Drag St. Jude Down?

March 28, 2013 1:31 pm | by Mass Device | News | Comments

Wall Street didn't move much on news of another insulation-related failure in St. Jude Medical's next-generation Durata defibrillator leads this week. The case report included a detailed analysis of an incident in which a Durata lead failed due to inside-out abrasion...

Results of St. Jude Medical's RESPECT Trial Published in The New England Journal of Medicine

March 20, 2013 5:08 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 20, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced publication of results from its landmark RESPECT trial in The New England Journal of Medicine. The study results show that device closure using the AMPLATZER™ PFO...

St. Jude Medical launches Ilumien Optis in Japan

March 12, 2013 10:03 am | by Mass Device | News | Comments

St. Jude Medical (NYSE:STJ) said its launched the Ilumien Optis device in Japan, calling it the only medical device on the market to combine fractional flow reserve and optical coherence tomography technology to allow doctors to evaluate the state and severity of coronary lesions.

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...

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...

St. Jude Medical to Present at the Barclays Global Healthcare Conference

February 27, 2013 4:20 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 27, 2013--St. Jude Medical, Inc. (NYSE:STJ) will present at the Barclays Global Healthcare Conference on Tuesday, March 12, in Miami. John Heinmiller, executive vice president, will address the conference at 10:15 a.m. EDT. The presentation will also be...

Study: 1 in 10 Recalled St. Jude Medical Riata Lead Coatings Fail Within Six Years

February 25, 2013 2:43 pm | by Mass Device | News | Comments

Danish researchers reported this week that their latest studies of St. Jude Medical's recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years. The study included 298 Danish patients, representing "virtually every living patient in Denmark who received Riata defibrillator leads," according to Heartwire.

St. Jude Looks Beyond Blood Pressure for Benefits of Renal Denervation

February 15, 2013 12:06 pm | by Mass Device | News | Comments

St. Jude Medical is aiming to take its renal denervation therapy a step further, looking for signs that the minimally invasive treatment improves health beyond lowering high blood pressure in patients with uncontrolled hypertension. The company's new Enlightnment trial is looking for long-term effects of renal denervation therapy...

Device Tax: We Need Action by Summer, Paulsen Says

February 4, 2013 3:43 pm | by Mass Device | News | Comments

Medical device industry advocate Rep. Erik Paulsen (R-Minn.) says Congress needs to act on the medical device tax by "late spring, early summer" this year. Rep. Erik Paulsen (R-Minn.), an unrelenting opponent of the medical device tax that took effect at the start of the year, still sees avenues for repeal tied to larger discussions of corporate tax reform. News Well, Capitol Hill, Medical Device Taxread more

Continuous spinal cord stimulation improves heart function

August 27, 2012 9:21 am | by European Society of Cardiology | News | Comments

Spinal cord stimulation improves heart function and could become a novel treatment option for heart failure, according to research presented at the ESC Congress 2012 today by Professor Hung-Fat Tse from Hong Kong. Heart failure is a progressive weakening of the heart muscle. It is a chronic condition that occurs when the heart cannot pump blood to meet the body’s needs.

St. Jude Medical Announces Next-Generation PressureWire for FFR Measurement

March 23, 2012 10:50 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for multiple enhancements to its PressureWireâ„¢ Fractional Flow Reserve (FFR) measurement guidewire.

Independent Data Safety Monitoring Board Recommends St. Jude Medical's FAME II Clinical Trial Stop Enrollment Following Positive Interim Analysis

January 19, 2012 5:13 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when...

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