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News Breaks
April 13, 2014
15:10 EDTMDT, EWMedtronic says CoreValve ruling has no impact outside U.S.
The Federal District Court of Delaware granted in part Edwards Lifesciences' (EW) motion for a preliminary injunction that prevents Medtronic (MDT) from selling or offering to sell its CoreValve System in the United States. The ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials. At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued. In addition, the court ordered Medtronic and Edwards Lifesciences to enter into discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant, CoreValve or the Edwards device, free from the limitations of the injunction. The court stated that CoreValve is a 'safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.' The court also found that the public interest favors enforcement of patent rights. The CoreValve System received approval from the FDA in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial.
News For MDT;EW From The Last 14 Days
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August 31, 2014
12:50 EDTMDT, EWEuropean Society of Cardiology to hold a conference
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August 28, 2014
17:42 EDTMDTJ&J begins sales process for its medical device unit Cordis, WSJ says
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09:05 EDTMDTMedtronic receives clearance for Shilla Growth Guidance System
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August 27, 2014
11:41 EDTMDTMedtronic management to meet with Jefferies
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10:05 EDTMDTMedtronic announces first implants in AdaptResponse CRT clinical trial
Medtronic announced the first implants in a clinical trial that will compare patient and healthcare system outcomes in heart failure patients who have cardiac resynchronization therapy devices with the AdaptivCRT feature enabled versus patients receiving standard CRT. The AdaptResponse trial will assess the superiority of the AdaptivCRT algorithm, which preserves normal heart rhythms and automatically adjusts to patients' needs to customize therapy. It is expected to enroll approximately 3K patients worldwide. The primary endpoint of the AdaptResponse trial is a combination of all-cause mortality and the rate of medical intervention for worsening heart failure. The trial also will examine the incidence of atrial fibrillation in enrolled patients. Other secondary endpoints will assess patient quality of life measures as well as cost-effectiveness of CRT devices with the AdaptivCRT feature relative to standard CRT. Patients will receive a CRT-pacemaker or CRT-defibrillator equipped with the AdaptivCRT algorithm, and will be randomized 1:1 to either treatment or control groups. Patients will be followed at three and six months after randomization, and then every six months until trial closure.
05:40 EDTMDTMedtronic sees impact of NGC Medical acquisition neutral to FY15 earnings
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August 26, 2014
19:33 EDTMDTCovidien shareholder sues to block sale to Medtronic, Bloomberg reports
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05:54 EDTMDTMedtronic acquires Sapiens SBS for $200M
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August 25, 2014
10:03 EDTMDTMedtronic announces FDA approval of Viva CRT-P for heart failure or AV block
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August 24, 2014
21:54 EDTEWPiper Jaffray to hold a bus tour
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August 21, 2014
08:29 EDTEWEdwards Lifesciences price target raised to $120 from $97 at JMP Securities
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August 20, 2014
08:47 EDTMDTMedtronic valuation attractive, says Morgan Stanley
Morgan Stanley said Medtronic's (MDT) valuation is attractive given pipeline execution, margin growth and shareholder returns, and expectations for the Covidien (COV) deal to go through. Shares are Overweight rated
07:18 EDTMDTMedtronic shares have upside with or without deal, says Deutsche Bank
Deutsche Bank sees limited downside risk and significant upside potential for shares of Medtronic (MDT), with or without the pending Covidien (COV) acquisition. Deutsche says the Q1 results show improving trends and it keeps a Buy rating on Medtronic with an $85 price target.
August 19, 2014
08:40 EDTMDTMedtronic sees FY15 gross margin of 74.5%-75%, with Q2 on lower end of range
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08:25 EDTMDTMedtronic: Negative factors in Spine segment in Q1 werre temporary
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08:22 EDTMDTMedtronic: We will continue to pay significant US taxes following Covidien deal
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07:19 EDTMDTMedtronic backs FY15 EPS view of $4.00-$4.10, consensus $4.04
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07:17 EDTMDTMedtronic reports Q1 EPS 93c, consensus 92c
Reports Q1 revenue $4.27B, consensus $4.25B.

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