Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations

Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3. Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years. The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prosecutors said in a DoJ release. The Onyx Liquid Embolic System won FDA approval in 2005 for blocking blood flow to arteriovenous malformations of the brain. Prosecutors in the case claim that sales reps from ev3 marketed the device for unapproved uses between 2005 and 2009, even after FDA officials contacted ev3 over “specific safety concerns regarding uses of Onyx outside the brain,” according to the release. In 2012, the FDA released a warning related to the Onyx system after receiving reports of more than 100 adverse events and nine patient deaths related to use of the device. “Ev3 disregarded laws designed to protect patient safety. The U.S. Attorney’s Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that medical device ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Featured Legal News Medtronic Source Type: news

Related Links:

Authors: Geng W, Tang H, Luo S, Lv Y, Liang D, Kang X, Hong W Abstract Although adipose derived stem cells (ADSCs) exert their therapeutic potential in ischemic stroke, the migration of ADSCs in injured area is not apparently observed after intravenous administration. ADSCs are an important source of exosomes which hold great promise as an endogenous drug delivery system for the treatment of cerebral ischemia given their ability to cross the blood-brain barrier. Here we investigated whether ADSCs-derived exosomes mediated miRNAs transfer and thus promoted neurological recovery after stroke. We first proved that miR...
Source: American Journal of Translational Research - Category: Research Tags: Am J Transl Res Source Type: research
Authors: Cervantes CE, Merino JL, Barrios V Abstract INTRODUCTION: Edoxaban is the last direct oral anticoagulant marketed for the prevention of stroke among patients with nonvalvular atrial fibrillation (AF). Areas covered: ENGAGE AF-TIMI 48 was the pivotal clinical trial that led to the approval of edoxaban 60 mg once daily. After the publication of this study, a great number of substudies and post hoc analyses have been published, together with some observational studies. The aim of this review was to update the current evidence about the use of edoxaban in AF patients. Expert commentary: In the ENGAGE AF-TIMI 4...
Source: Expert Review of Cardiovascular Therapy - Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research
Authors: Kotlęga D, Gołąb-Janowska M, Meller A, Bajer-Czajkowska A, Zembroń-Łacny A, Nowacki P, Banach M Abstract Introduction: Statins are widely used in stroke patients. The AHA/ASA guidelines recommend aggressive statin therapy in atherosclerotic stroke patients. Their beneficial effects are due to both their hypolipemic and pleiotropic properties. The aim of this study was to establish potential benefits from statin use in ischemic stroke patients with the diagnosis of atrial fibrillation (AF). Material and methods: Ischemic stroke patients with AF were enrolled in the study. Group I, the statin group ...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
In conclusion, in this series the most prevalent stroke mechanism was SUE, mainly embolic stroke of undetermined source. The outcome was excellent regardless of stroke mechanism.
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Stroke-like episodes (SLEs) are the hallmark of mitochondrial encephalopathy with lactic acidosis and stroke-like episode (MELAS) syndrome but rarely occur also in other specific or nonspecific mitochondrial disorders. Pathophysiologically, SLLs are most likely due to a regional disruption of the blood-brain barrier triggered by the underlying metabolic defect, epileptic activity, drugs, or other factors. SLEs manifest clinically with a plethora of cerebral manifestations, which not only include features typically seen in ischemic stroke, but also headache, epilepsy, ataxia, visual impairment, vomiting, and psychiatric abnormalities.
Source: Journal of the Neurological Sciences - Category: Neurology Authors: Tags: Review Article Source Type: research
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: ClinicalTrials.gov - 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
More News: Brain | Health Management | Ischemic Stroke | Legislation | Marketing | Medical Devices | Medical Ethics | Mergers and Aquisitions | Neurology | Stroke | USA Health | Warnings