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November 6, 2012
19:25 EDTMDTMedtronic finds biventricular pacing may offer significant clinical advantage
Medtronic announced interim findings from the BLOCK HF trial, which show that biventricular pacing may offer a significant clinical advantage and improved patient outcomes over conventional right ventricular pacing among patients with left ventricular systolic dysfunction and atrioventricular block who are indicated for a pacemaker. Presented as a late-breaking clinical trial at the American Heart Association's 2012 Scientific Sessions, BLOCK HF shows a 27% relative risk reduction in the composite of death and healthcare utilization visits requiring intravenous heart failure therapy among this patient population. The CRT devices used in the BLOCK HF trial are not approved by the FDA for the patient population studied at this time.
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April 21, 2014
18:20 EDTMDTEdwards Lifesciences comments on U.S. Appeals Court order
Edwards Lifesciences (EW) announced that the U.S. Court of Appeals for the Federal Circuit issued a stay for the preliminary injunction that was ordered on April 11 to limit the sale of Medtronic's (MDT) CoreValve system in the United States. According to the court's two-to-one decision, the injunction has been placed on hold "pending further notice." "We have always made every effort to ensure patients receive the treatment they need and will continue to seek a durable solution that benefits physicians and their patients. We're proud of the track record and large amount of clinical data supporting the performance of the SAPIEN family of valves, making them the preferred choice for doctors treating their patients around the world," said Michael A. Mussallem, Edwards' chairman and CEO. The order postpones the implementation of the preliminary injunction. It does not reverse the federal jury's finding of Medtronic's willful infringement, for which all appeals have been exhausted, and does not affect the determination of additional damages.
16:40 EDTMDTMedtronic confirms stay in case with Edwards regarding CoreValve granted
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15:55 EDTMDTMedtronic motion for stay in case with Edwards granted, Bloomberg reports
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15:42 EDTMDTLeerink's medical devices analyst holds an analyst/industry conference call
Medical Devices Analyst Antalffy discusses the litigation landscape and the next steps and potential outcomes for Edwards Lifesciences and Medtronic on an Analyst/Industry conference call to be held on April 23 at 2 pm.
09:09 EDTMDTMedtronic reports court to expedite appeal in Edwards Lifesciences case
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07:21 EDTMDTFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 16, 2014
17:53 EDTMDTEdwards says not looking for complete ban of Medtronic valve, Bloomberg says
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April 14, 2014
16:24 EDTMDTOn The Fly: Closing Wrap
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12:26 EDTMDTOn The Fly: Midday Wrap
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10:51 EDTMDTEdwards up after court limits sale of Medtronic's CoreValve in U.S.
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10:02 EDTMDTOn The Fly: Analyst Downgrade Summary
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09:00 EDTMDTMedtronic falls 5.4%
Medtronic is down 5.4%, or $3.20, to $56.00
08:59 EDTMDTOn The Fly: Pre-market Movers
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07:39 EDTMDTEdwards Lifesciences upgraded to Buy from Fair Value at CRT Capital
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06:22 EDTMDTMedtronic downgraded to Neutral from Overweight at JPMorgan
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06:21 EDTMDTEdwards Lifesciences upgraded to Neutral from Underweight at JPMorgan
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April 13, 2014
15:10 EDTMDTMedtronic says CoreValve ruling has no impact outside U.S.
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April 12, 2014
19:50 EDTMDTEdwards says court limits sale of Medtronic CoreValve system in U.S.
Edwards Lifesciences (EW) announced that the U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's (MDT) CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days. The hearing related to a federal jury decision in 2010 that CoreValve willfully infringes Edwards' U.S. Andersen transcatheter aortic valve replacement patent. At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on what instances the CoreValve device could continue to be used in the treatment of U.S. patients at centers currently trained on CoreValve. There is a large body of evidence demonstrating the safety and performance of the Edwards SAPIEN valves, and the company remains committed to ensuring patients have appropriate access to transcatheter therapy. This case was initiated by Edwards in 2008. On April 1, 2010, a federal jury found Medtronic willfully infringed Edwards' U.S. Andersen patent and awarded damages. In Nov. 2012, the U.S. Court of Appeals for the Federal Circuit affirmed the jury decision; in Oct. 2013, the U.S. Supreme Court declined to hear Medtronic's appeal. The patent involved in this suit is part of the Andersen family of patents. The U.S. Andersen patent was issued in 1995. A petition has been filed with the U.S. Patent and Trademark Office to extend this patent into early 2016. In a separate case, a federal jury in January found that Medtronic CoreValve had willfully infringed Edwards' U.S. Cribier transcatheter heart valve patent, and awarded damages to Edwards in that trial.
April 10, 2014
19:10 EDTMDTMedtronic confirms FDA approval for expanded indications
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16:32 EDTMDTMedtronic gets FDA approval for revised labeling application
The U.S. FDA approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers and eight cardiac resynchronization defibrillators, expanding the indication for use to patients with atrioventricular block and less severe heart failure. The FDA previously approved these devices for patients with more severe heart failure as evaluated by their physician using specific criteria. The new approved use includes patients with less severe heart failure, but who are already indicated to receive RV pacing. With the new indication, these patients will be eligible to receive a device that will pace both sides of their heart instead of just the right. Reference Link
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