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News Breaks
April 21, 2014
09:09 EDTMDT, EWMedtronic reports court to expedite appeal in Edwards Lifesciences case
Medtronic (MDT) issued an updated statement on the recent ruling by Federal District Court of Delaware. The ruling granted in part Edwards Lifesciences' (EW) motion for a preliminary injunction that prevents Medtronic from selling or offering to sell its CoreValve System in the U.S., except through a mechanism that Medtronic is pursuing with Edwards Lifesciences that would allow currently trained sites to treat patients with CoreValve based on a physician's medical judgment. The injunction will go into effect on April 23. Medtronic has asked the U.S. Circuit Court of Appeals to postpone the injunction until it can determine if the injunction was properly issued. The Court has not yet ruled. Medtronic also requested, and the Court agreed to, an expedited appeal of the injunction ruling, and other underlying legal issues, with the last appeal brief to be submitted by June 19. Medtronic does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunction, particularly with respect to the impact it will have on the public health interest. As written in the District Court order, Medtronic and Edwards Lifesciences have entered into discussions in an effort to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve 'to make clinical, patient-by-patient determinations as to whether to implant without being constrained by the number of CoreValve...available.' On May 21, Medtronic and Edwards are to report the status of these discussions to the District Court, but if an agreement is reached before that time, it may be implemented.
News For MDT;EW From The Last 14 Days
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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 EDTEW, MDTMedtronic 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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June 21, 2015
12:42 EDTMDTMedtronic reports five-year follow-up results for Endurant AAA stent graft
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June 19, 2015
17:02 EDTMDTMedtronic acquires Aptus Endosystems for $110M
Medtronic announced it has acquired the assets of Aptus Endosystems, a Sunnyvale, Calif. based, privately held medical device company focused on developing advanced technology for endovascular aneurysm repair and thoracic endovascular aneurysm repair. Medtronic completed its acquisition of the assets of Aptus Endosystems in a transaction valued at approximately $110M. Additional terms of the acquisition were not disclosed.
09:23 EDTMDTMedtronic acquires CardioInsight Technologies
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09:21 EDTMDTMedtronic approves repurchase of addition 80M shares
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09:20 EDTMDTMedtronic raises quarterly dividend by 25% to 38c per share
The board of Medtronic approved a 25% increase in its cash dividend for FY16, raising the quarterly amount to 38c per ordinary share for an annual amount of $1.52 per ordinary share. The dividend is payable on July 17, to shareholders of record at the close of business on June 29.

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