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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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May 5, 2015
09:32 EDTMDTMedtronic announces FDA clearance, US launch of Euphora coronary balloon
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May 4, 2015
14:03 EDTMDTMedtronic announces launch of Divergence Stand Alone Interbody Cage
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10:02 EDTMDTMedtronic receives FDA clearance for ZEVO anterior cervical plate system
Medtronic announced it has received 510(k) clearance from the FDA to market the ZEVO Anterior Cervical Plate System. This system is now commercially available for the treatment of cervical degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions.
May 3, 2015
18:11 EDTMDTSiemens investigated by Chinese regulator last year, Reuters says
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April 30, 2015
10:11 EDTEWHigh option volume stocks
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09:22 EDTMDTMedtronic initiates study of AF treatment with ablation procedures combination
Medtronic announced the start of a clinical study using Medtronic technologies to determine whether paroxysmal and persistent atrial fibrillation, or AF, can be treated with a combination of two ablation procedures targeting different anatomical locations - specifically, the pulmonary veins and the renal arteries. Study patients will also receive an implantable cardiac monitor to track their heart rhythm on an automatic and continuous basis. Patients in both arms of the trial also will receive a Reveal LINQ Insertable Cardiac Monitor to automatically and continuously detect and record the net recurrence of abnormal heart rhythms after therapy randomization. This more comprehensive method of cardiac monitoring will provide greater detail and accuracy about the treatment effect of combination therapy with PVI and renal denervation versus PVI alone. SYMPLICITY AF will enroll up to 245 patients in up to 12 centers throughout the United States. Seventy of these patients meeting all inclusion but no exclusion criteria and thus determined to be eligible for the trial will then be randomized to either PVI and RDN or PVI alone; all randomized subjects will receive a Reveal LINQ ICM. The primary safety endpoint is comprised of events related to both the PVI and RDN procedures. The primary efficacy endpoint will measure freedom of chronic treatment failure, defined as AF lasting 30 seconds or longer or the requirement for an intervention for atrial fibrillation through a minimum of six months. Heart rhythm data from the Reveal LINQ ICM will be reviewed monthly.
April 29, 2015
06:49 EDTMDTMedtronic's stent graft system shows positive results
Medtronic's Endurant AAA stent graft system delivered positive results for endovascular repair of abdominal aortic aneurysmsin patients with short and standard neck lengths who were enrolled in the global ENGAGE registry. Delivery and deployment was successful in 99.4% of the patients with a standard neck and in 100% of the patients with a short neck. Through four years, the two groups showed similar results in terms of secondary endovascular procedures, ruptures or conversions to open repair, and no main body migrations were reported in any of the patients.
April 27, 2015
15:35 EDTMDTMedtronic announces consent decree with FDA for Synchromed system
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15:31 EDTMDTFDA enters consent decree with Medtronic
The FDA announced the filing of a consent decree against Medtronic and two of the company’s officers—S. Omar Ishrak and Thomas Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
11:02 EDTMDTMedtronic begins clinical study of Endurant Evo AAA strent graft system
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April 23, 2015
19:16 EDTEWOn The Fly: After Hours Movers
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16:19 EDTEWEdwards Lifesciences sees Q2 EPS $1.00-$1.10, consensus $1.05
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16:18 EDTEWEdwards Lifesciences narrows FY15 EPS view to $4.10-$4.30, consensus $4.21
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16:17 EDTEWEdwards Lifesciences reports Q1 EPS $1.12, consensus $1.04
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15:00 EDTEWNotable companies reporting after market close
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