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Cochrane announces funding support for 10 new Cochrane Reviews
The Cochrane Editorial Unit is pleased to announce the 10 successful titles from the second Cochrane Review Support Programme (CRSP) funding round.Delayed antibiotics for respiratory infections (Acute Respiratory Infections Group) Bisphosphonates and other bone agents for breast cancer (Breast Cancer Group)Psychological therapies for the treatment of mental disorders in low- and middle-income countries affected by humanitarian crises (Common Mental Disorders Group)Drug eluting stents versus bare metal stents for acute coronary syndrome (Heart Group)Withdrawal of antihypertensive drugs in older people (Hypertension Group)Ph...
Source: Cochrane News and Events - June 27, 2016 Category: Information Technology Authors: nowens at cochrane.org Source Type: news

FDA OKs expansion of InVivo Therapeutics spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA cleared an expansion of its Inspire study of its neuro-spinal scaffold, now set to enroll up to 20 patients, and announced the 9th and 10th implantation in the trial, though the 10th patient died of an unrelated stroke. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. The federal watchdog cleared the company to expand the trial for up to 20 evaluable patients. The decision came based off the review of 6-month safety data from the trial, InViv...
Source: Mass Device - July 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Spinal InVivo Therapeutics Corp. Source Type: news

Impact of renal function on the effects of LDL cholesterol lowering with statin-based regimens: a meta-analysis of individual participant data from 28 randomised trials
Publication date: Available online 29 July 2016 Source:The Lancet Diabetes & Endocrinology Author(s): Cholesterol Treatment Trialists' (CTT) Collaboration Background Statin therapy is effective for the prevention of coronary heart disease and stroke in patients with mild-to-moderate chronic kidney disease, but its effects in individuals with more advanced disease, particularly those undergoing dialysis, are uncertain. Methods We did a meta-analysis of individual participant data from 28 trials (n=183 419), examining effects of statin-based therapy on major vascular events (major coronary event [non-fatal myoca...
Source: The Lancet Diabetes and Endocrinology - July 28, 2016 Category: Endocrinology Source Type: research

Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial
Publication date: Available online 23 August 2016 Source:The Lancet Neurology Author(s): Kevin N Sheth, Jordan J Elm, Bradley J Molyneaux, Holly Hinson, Lauren A Beslow, Gordon K Sze, Ann-Christin Ostwaldt, Gregory J del Zoppo, J Marc Simard, Sven Jacobson, W Taylor Kimberly Background Preclinical models of stroke have shown that intravenous glyburide reduces brain swelling and improves survival. We assessed whether intravenous glyburide (RP-1127; glibenclamide) would safely reduce brain swelling, decrease the need for decompressive craniectomy, and improve clinical outcomes in patients presenting with a large hemispheric...
Source: The Lancet Neurology - August 23, 2016 Category: Neurology Source Type: research

Edoxaban versus enoxaparin –warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial
Publication date: Available online 30 August 2016 Source:The Lancet Author(s): Andreas Goette, Jose L Merino, Michael D Ezekowitz, Dmitry Zamoryakhin, Michael Melino, James Jin, Michele F Mercuri, Michael A Grosso, Victor Fernandez, Naab Al-Saady, Natalya Pelekh, Bela Merkely, Sergey Zenin, Mykola Kushnir, Jindrich Spinar, Valeriy Batushkin, Joris R de Groot, Gregory Y H Lip Background Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled enoxaparin–warfarin therapy. Few safety d...
Source: The Lancet - August 30, 2016 Category: Journals (General) Source Type: research

Finding tech passion in an unlikely place
With many gains in health information technology over the past decade, newly appointed National Coordinator for Health IT Vindell Washington, MD, took time at Health 2.0 last week to describe his first experience with health technology, what it means for the health care community and new tools for physicians and entrepreneurs. Dr. Washington found his passion for health care technology as a captain in the U.S. Army. He was stationed in Haiti leading the emergency department in the 28th combat support hospital when a patient presented with “a fever, a rash, a really unusual constellation of symptoms,” he said. Unable ...
Source: AMA Wire - October 4, 2016 Category: Journals (General) Authors: Troy Parks Source Type: news

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial
Publication date: Available online 31 October 2016 Source:The Lancet Author(s): Timo Mäkikallio, Niels R Holm, Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Markku Eskola, Hannu Romppanen, Thomas Kellerth, Jan Ravkilde, Lisette O Jensen, Gintaras Kalinauskas, Rikard B A Linder, Markku Pentikainen, Anders Hervold, Adrian Banning, Azfar Zaman, Jamen Cotton, Erlend Eriksen, Sulev Margus, Henrik T Sørensen, Per H Nielsen, Matti Niemelä, Kari Kervinen, Jens F Lassen, Michael Maeng, Keith Oldroyd, Geoff Berg, Simon J Walsh, Colm G Hanratty, Indulis Kumsars, Peteris Stradins, Terje K Steigen, O...
Source: The Lancet - October 31, 2016 Category: Journals (General) Source Type: research

AliveCor raises $30m, launches Kardia Pro platform in U.S.
AliveCor said today that it landed $30 million in a series D funding round and that it released its artificial intelligence-enabled Kardia Pro platform in the U.S. The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia. “Heart disease is the No. 1 cause of death in the United States, claiming more lives than all forms of cancer combined. To manage heart disease and stroke risk, leading cardiologists want to see more than just ECGs from their patients,” CEO Vic Gundotra said in prepared remarks. “Kardia Pro tracks important meas...
Source: Mass Device - March 16, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat AliveCor Source Type: news

Anaconda Biomed raises $17m for next-gen brain thrombectomy device
Anaconda Biomed said it raised nearly $17 million (€15 million) in a Series A round for the neurothrombectomy device it’s developing. The round, led by new investors Ysios Capital, Omega Funds and Banco Sabadell and prior backer Innogest Capital, is enough to carry the ANCD Brain device through validation & verification and clinical studies ahead of a CE Mark bid in the European Union, co-founder & CEO Ofir Arad said in prepared remarks. The proceeds are also earmarked for an initial approval submission to the FDA, Arad said. Ysios general partner Josep Sanfeliu and Omega Funds managing director Claudio...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Neurological Anaconda Biomed Source Type: news

Finland extends due date on Nexstim R & D loans
Nexstim said today that the Finnish Funding Agency for Innovation has agreed to extend the due date for repayment of 2 of its research & development project loans. According to the agreement, the company was supposed to provide cash repayments up to €1.8 million ($2 million) between 2017 and 2019. Now, that range has been pushed back to between 2020 and 2022. The company has to fully repay both loans to Tekes by the end of 2023, Nexstim said. “This agreement, which reschedules our R&D loan repayment payments to Tekes, will have a positive effect on Nexstim’s cash flow and will help to support our workin...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Neurological Wall Street Beat Nexstim Source Type: news

Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study
Publication date: Available online 13 June 2017 Source:The Lancet Author(s): Linxin Li, Olivia C Geraghty, Ziyah Mehta, Peter M Rothwell Background Lifelong antiplatelet treatment is recommended after ischaemic vascular events, on the basis of trials done mainly in patients younger than 75 years. Upper gastrointestinal bleeding is a serious complication, but had low case fatality in trials of aspirin and is not generally thought to cause long-term disability. Consequently, although co-prescription of proton-pump inhibitors (PPIs) reduces upper gastrointestinal bleeds by 70–90%, uptake is low and guidelines are conflicti...
Source: The Lancet - June 15, 2017 Category: General Medicine Source Type: research

Cardiac imaging dev VerAvanti raises $5m
Previously-stealthy cardiac imaging developer VerAvanti said today it raised $5 million in a recent round of financing to support its Scanning Fiber Endoscope device development. The Redmond, Wash.-based company’s SFE device uses technology licensed from the University of Washington and consists of an imaging station and micro-sized catheter which can take high-quality images inside of vessels to improve the diagnosis and treatment of stroke and other heart conditions. VerAvanti said that it has received 2 NIH research Phase 1 grants totaling $586,000 in May and June, alongside support from the company’s founder Ge...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Imaging VerAvanti Source Type: news

Development and validation of Risk Equations for Complications Of type 2 Diabetes (RECODe) using individual participant data from randomised trials
Publication date: Available online 10 August 2017 Source:The Lancet Diabetes & Endocrinology Author(s): Sanjay Basu, Jeremy B Sussman, Seth A Berkowitz, Rodney A Hayward, John S Yudkin Background In view of substantial mis-estimation of risks of diabetes complications using existing equations, we sought to develop updated Risk Equations for Complications Of type 2 Diabetes (RECODe). Methods To develop and validate these risk equations, we used data from the Action to Control Cardiovascular Risk in Diabetes study (ACCORD, n=9635; 2001–09) and validated the equations for microvascular events using data from the Di...
Source: The Lancet Diabetes and Endocrinology - August 11, 2017 Category: Endocrinology Source Type: research

Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial
This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. Findings Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (pnon-inferiority=0·0004; hazard ratio [HR] 0·81 [95% CI 0·62–1·06], psuperiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-es...
Source: The Lancet - August 29, 2017 Category: General Medicine Source Type: research

Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial
Publication date: Available online 28 August 2017 Source:The Lancet Author(s): Robert P Giugliano, Terje R Pedersen, Jeong-Gun Park, Gaetano M De Ferrari, Zbigniew A Gaciong, Richard Ceska, Kalman Toth, Ioanna Gouni-Berthold, Jose Lopez-Miranda, François Schiele, François Mach, Brian R Ott, Estella Kanevsky, Armando Lira Pineda, Ransi Somaratne, Scott M Wasserman, Anthony C Keech, Peter S Sever, Marc S Sabatine Background LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relations...
Source: The Lancet - August 29, 2017 Category: General Medicine Source Type: research