Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum

Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition. Covidien bought ev3 in 2010 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System. FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. Although the device was only approved for use inside the brain, the DOJ claims ev3 sales reps encouraged surgeons to use Onyx in large quantities for procedures outside the brain. FDA officials reportedly raised concern in 2008 about the use of Onyx outside the brain and told ev3 it would have to conduct a study to gain approval for outside-the-brain procedures. Investigators say that instead of conducting such a study, ev3 reps attended surgical procedures and provided explicit instructions to surgeons about how to use the device for unapproved procedures outside the brain, including in greater quantities than would be used in the brain. The company also allegedly set up a system of sales quotas and bonuses that incentivized reps to sell Onyx for unapproved uses and trained its sales force on how to instruct...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

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CONCLUSION: Infection was an important risk factor for children with AIS in China. Infection and thrombophilia risk factors were more likely to occur in isolation. The stroke lesions commonly occurred in the basal ganglia region. PMID: 30890011 [PubMed - as supplied by publisher]
Source: Fetal and Pediatric Pathology - Category: Pathology Tags: Fetal Pediatr Pathol Source Type: research
Source: BMJ Comments - Category: General Medicine Source Type: forums
Condition:   Arterial Ischemic Stroke Intervention:   Sponsor:   Assistance Publique - Hôpitaux de Paris Not yet recruiting
Source: - Category: Research Source Type: clinical trials
gro G Abstract Background: Combination of dual antiplatelet (DAPT) and oral anticoagulation therapy is required to decrease cardioembolic stroke and stent thrombosis risk in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS). We compared the safety and efficacy of dabigatran etexilate with vitamin K antagonist (VKA), in combination with DAPT (aspirin plus clopidogrel) treatment in AF patients who underwent percutaneous coronary intervention (PCI) with stenting for ACS. Methods: Consecutive nonvalvular AF patients who received twice-daily dabigatran 110 mg (n = 389) or VKA (n = 510) and D...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
ConclusionImproved monitoring systems make them indispensable tools for detecting emboligenic arrhythmias in the aftermath of cryptogenic stroke. Other studies of greater powers are needed to make a finer selection of patients to benefit.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Conclusions: Higher serum albumin is associated with lower HT risk in a dose-dependent manner in AIS patients younger than 60 years.Cerebrovasc Dis 2019;47:88 –94
Source: Cerebrovascular Diseases - Category: Neurology Source Type: research
CONCLUSIONS: This study confirms that the guidelines are routinely followed in clinical practice in this rural population. PMID: 30889960 [PubMed - in process]
Source: Rural and Remote Health - Category: Rural Health Tags: Rural Remote Health Source Type: research
Discussion-Local manifestations of snake bite are soft-tissue swelling from edema, necrosis, and hemorrhage. Common long-term sequelae of envenomation is soft-tissue atrophy distal to the bite, particularly in the digits.-Systemic signs and symptoms after a venomous snake bite are due to anticoagulant/procoagulant activity or neurotoxicity. Cerebral hypoxia can occur due to hypotensive shock that may accompany some snake bite envenomations. Neuromuscular disorders with damage of the peripheral nervous system can with blockage of synaptic transmission, at either presynaptic or postsynaptic levels.Common neuro...
Source: Sumer's Radiology Site - Category: Radiology Authors: Source Type: blogs
AbstractExtracranial internal carotid artery dissection (ICAD) is a potential source of morbidity and mortality in trauma patients and requires high degree of suspicion for diagnosis after the initial presentation. Occasionally, if standard therapy is contraindicated, endovascular reconstruction is a treatment option. The aim of this systematic review was to report clinical and radiographic outcomes following endovascular repair of ICAD of traumatic and iatrogenic etiology. A comprehensive systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines...
Source: Neurosurgical Review - Category: Neurosurgery Source Type: research
Publication date: Available online 20 March 2019Source: Journal of Clinical NeuroscienceAuthor(s): Pouria Moshayedi, Shashvat M. Desai, Ashutosh P. JadhavAbstractParallel to a more widespread application of endovascular neurothrombectomy in acute ischemic stroke, it is critical to understand the nature and management of associated complications, including wire perforation of the middle cerebral artery (MCA). Sacrifice of the perforated vessel may be necessary to avoid fatal intra-cranial hemorrhage. Here we describe a case of right MCA distribution ischemia complicated by a right MCA perforation. Using super selective inje...
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
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