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Stock Market & Financial Investment News

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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July 6, 2015
10:01 EDTEWOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: 58.com (WUBA) upgraded to Buy from Hold at Summit Research... Altria Group (MO) upgraded to Buy from Outperform at CLSA... Ares Commercial (ACRE) upgraded to Outperform from Market Perform at FBR Capital... BAE Systems (BAESY) upgraded to Overweight from Equal Weight at Morgan Stanley... BGC Partners (BGCP) upgraded to Strong Buy from Outperform at Raymond James... Cognizant (CTSH) upgraded to Buy on valuation at CLSA... Edwards Lifesciences (EW) upgraded to Overweight from Equal Weight at Morgan Stanley... Guess (GES) upgraded to Neutral from Underweight at Piper Jaffray... MarkWest Energy (MWE) upgraded to Overweight from Equal Weight at Barclays... Palo Alto (PANW) upgraded to Outperform following checks at Cowen... The Medicines Co. (MDCO) upgraded to Buy from Neutral at Mizuho... TripAdvisor (TRIP) upgraded to Equal Weight from Underweight at Barclays... Union Pacific (UNP) upgraded to Outperform at Cowen... United Continental (UAL) upgraded to Buy from Fair Value at CRT Capital... eHealth (EHTH) upgraded on Medicare outlook, risk/reward at RBC Capital.
08:04 EDTEWEdwards Lifesciences upgraded to Overweight from Equal Weight at Morgan Stanley
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July 2, 2015
12:05 EDTMDTMedtronic reports 12-month results of VeClose pivotal study
Medtronic announced the twelve- month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal closure system for the treatment of incompetent greater saphenous veins with a 96.8% closure rate. The results were presented by National Principal Investigator, Nick Morrison, M.D., Morrison Vein Institute, Scottsdale, Ariz., at the European Venous Forum 2015 in St. Petersburg, Russia. The VenaSeal closure system is a unique, minimally invasive, non-tumescent, non- thermal and non-sclerosant procedure that uses an advanced medical adhesive to close the diseased vein in patients with symptomatic venous reflux disease. Unlike other treatments, the VenaSeal closure system does not require tumescent anesthesia, allowing patients to return to their normal activities following the procedure. The VenaSeal procedure also eliminates the risk of nerve or other heat-related injury associated with thermal-based procedures, and may reduce the need for compression stockings post-procedure. The 12 month results of the VeClose study demonstrated outcomes for the VenaSeal closure system comparable with the closure rates associated with the ClosureFast catheter and demonstrated non-inferiority of the VenaSeal closure system: At three months, the complete closure of the great saphenous veins achieved in more than 98.9% of patients treated with the VenaSeal closure system compared to 95.4% of patients treated with the ClosureFast catheter, showing non-inferiority of VenaSeal (p<.0001). The closure rate at six months was 98.9% and 94.3% for the VenaSeal closure system and the ClosureFast catheter, respectively. At 12 months, closure rates were identical between the two treatment groups at 96.8%. Additionally, no serious adverse events were reported.
June 29, 2015
18:13 EDTMDTMedtronic says AHA/ASA recommends stent retriever technology
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June 25, 2015
11:03 EDTMDTMedtronic announces U.S. launch of Advisa SR MRI SureScan pacing system
Medtronic announced the U.S. FDA approval and commercial launch of the Advisa SR MRI SureScan single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging scans positioned on any region of the body without restrictions. The new system includes the Advisa SR MRI pacemaker and a SureScan lead, which must be used together to be considered MR- conditional.
09:23 EDTMDTMedtronic announces resignation of Christopher O'Connell
Medtronic (MDT) announced in a regulatory filing that Christopher J. O’Connell is resigning as the company’s EVP and President, Restorative Therapies Group. The company also announced the appointment of Geoff Martha as the company’s EVP and President, Restorative Therapies Group, effective immediately. The Fly notes that Waters (WAT) this morning named O'Connell as its new president, CEO and member of its Board of Directors, effective in September.
09:15 EDTMDTWaters names Christopher O'Connell as CEO, effective in September
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June 23, 2015
17:03 EDTMDTMedtronic implements voluntary recall for certain lots of Covidien Shiley tubes
Medtronic announced that on May 8, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to November 29, 2012 addressed the patient breathing difficulty or discomfort. The notification requested all customers and distributors to quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit. Medtronic also took the necessary steps to prevent future shipments of the recalled products. The company also notified regulatory agencies around the world, as appropriate. Since November 29, 2012, Shiley tracheostomy tubes were shipped into Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States of America.
11:20 EDTMDT, EWMedtronic competitive with Edwards after approval, says Wells Fargo
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09:22 EDTMDTMedtronic announces FDA approval for new TAVR system
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07:25 EDTMDT, EWPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
07:17 EDTEWFeedback on Edwards Lifesciences Centera 'very positive,' says Wells Fargo
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