Medtronic wins FDA nod for thoracotomy-based HVAD procedure

Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach. The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device. The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also indicated a reduction in hospital stay length, down from an average of 26.1 days to 18 days, Medtronic said. Overall survival amongst patients who underwent a thoracotomy-based HVAD implantation was 88.8% at one year, Medtronic said. “We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD system, which gives physicians added flexibility in treating a broad range of patients. Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays,” Lateral trial principal investigator Dr. Edwin McGee Jr. of the Loyola University Medical Center said in a prepared statement. The company said that along with the approval, it has released tools designed to assist specifically with the th...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

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Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news
CONCLUSIONS: PA use may reduce initial stroke severity in AT stroke and the risk of END, and can improve functional outcome at three months irrespective of stroke subtypes. PMID: 30429408 [PubMed - as supplied by publisher]
Source: Journal of Atherosclerosis and Thrombosis - Category: Cardiology Tags: J Atheroscler Thromb Source Type: research
CONCLUSION: Mechanical inspiration and expiration exercise had a therapeutic effect on velopharyngeal incompetence in subacute stroke patients with dysphagia. This therapy is easy to provide clinically and could be a useful therapeutic strategy for velo-pharyngeal incompetence with dysphagia in patients with stroke. PMID: 30426133 [PubMed - as supplied by publisher]
Source: Journal of Rehabilitation Medicine - Category: Rehabilitation Tags: J Rehabil Med Source Type: research
Authors: Hildick-Smith D, Turner M, Shaw L, Nakum M, Ó Hartaigh B, Evans RM, Rhodes JF, Sondergaard L, Kasner SE Abstract AIMS: Percutaneous closure of a patent foramen ovale (PFO) is known to lower the risk of recurrent stroke in patients with a cryptogenic stroke. However, the economic implications of transcatheter PFO closure are less well known. From a UK payer perspective, we performed a detailed economic appraisal of PFO closure for prevention of recurrent ischemic stroke in patients with a PFO who had experienced a cryptogenic stroke. MATERIALS AND METHODS: A Markov cohort model was constructed us...
Source: Journal of Medical Economics - Category: Health Management Tags: J Med Econ Source Type: research
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Source: Journal of Neuroradiology - Category: Radiology Source Type: research
Condition:   Ischemic Stroke Interventions:   Other: head-down position treatment;   Other: guideline-based treatment Sponsor:   General Hospital of Shenyang Military Region Not yet recruiting
Source: - Category: Research Source Type: clinical trials
Smoke masks. Eye drops. No outdoor exercise. This is how Californians are trying to cope with wildfires choking the state, but experts say an increase in serious health problems may be almost inevitable for vulnerable residents as the disasters become more commonplace. Research suggests children, the elderly and those with existing health problems are most at risk. Short-term exposure to wildfire smoke can worsen existing asthma and lung disease, leading to emergency room treatment or hospitalization, studies have shown. Increases in doctor visits or hospital treatment for respiratory infections, bronchitis and pneumonia i...
Source: JEMS: Journal of Emergency Medical Services News - Category: Emergency Medicine Authors: Tags: Patient Care News Source Type: news
Publication date: Available online 16 November 2018Source: Brain, Behavior, and ImmunityAuthor(s): Raymond Wong, Nikolett Lénárt, Laura Hill, Lauren Toms, Graham Coutts, Bernadett Martinecz, Eszter Császár, Gábor Nyiri, Athina Papaemmanouil, Ari Waisman, Werner Müller, Markus Schwaninger, Nancy Rothwell, Sheila Francis, Emmanuel Pinteaux, Adam Denes, Stuart M. AllanAbstractThe cytokine interleukin-1 (IL-1) is a key contributor to neuroinflammation and brain injury, yet mechanisms by which IL-1 triggers neuronal injury remain unknown. Here we induced conditional deletion of IL-1R1 in ...
Source: Brain, Behavior, and Immunity - Category: Neurology Source Type: research
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Source: Acta Neurologica Belgica - Category: Neurology Source Type: research
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Source: Acta Neurologica Belgica - Category: Neurology Source Type: research
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