MassDevice.com +5 | The top 5 medtech stories for August 18, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. HeartWare recalls some HVAD implantable heart pumps on electrical fault risk HeartWare International this week recalled some of its HVAD implantable heart pumps on the risk of electrical faults from driveline contamination. The recall affects an unspecified number of the left ventricular assist devices, according to an August 15 letter the Framingham, Mass.-based company sent to physicians who implant the pump. Connector contamination of the driveline most often occurred in the 1st 30 days, according to HeartWare, which agreed in June to a $1.1 billion acquisition by Medtronic. Read more 4. Spectral Medical eyes final PMA bid by year-end for Toraymyxin anti-sepsis device Spectral Medical said today that it plans to file its final pre-market approval module with the FDA for its sepsis treatment by the end of the year, after the impending release of primary endpoint data from a clinical trial. The Toronto-based company developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use hemoperfusion to remove...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news

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Insufficient sleep and irregular sleep/wake rhythm are common problems among university students. We investigated the effect of sleep/wake rhythm and excessive daytime sleepiness (EDS) on the cortical oxygenation as measured by near-infrared spectroscopy (...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
This study provides evidence of adoption of TORS in Australia and New Zealand; however, there is a perception that significant barriers to adoption persist. Results from this study may help guide decisions on how we train and license surgeons in the era of this technology.
Source: Journal of Robotic Surgery - Category: Surgery Source Type: research
Condition:   Pain After TJA Interventions:   Drug: Melatonin 5 mg;   Drug: Placebo Oral Tablet;   Drug: Magnesium 500Mg Oral Tablet Sponsor:   Stanford University Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Infant Apnea;   Neonatal Abstinence Syndrome;   Sleep Interventions:   Device: NEATCAP;   Device: SVS mattress Sponsors:   Elisabeth Salisbury;   National Heart, Lung, and Blood Institute (NHLBI) Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Aortic Valve Stenosis Interventions:   Device: Aortic valve replacement using a nitinol blade;   Procedure: aortic valve replacement Sponsor:   Cliniques universitaires Saint-Luc- Université Catholique de Louvain Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Sleep;   Physical Activity;   Family and Household;   Computer, Attitude to;   Adolescent Behavior Interventions:   Behavioral: Family Media Use Plan;   Behavioral: Media Use Resources Awareness Sponsors:   University of Wisconsin, Madison;   Facebook, Inc Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
LivaNova (NSDQ:LIVN) handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide. Formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, in April the company closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) and paid $250 million to acquire TandemLife and its cardiopulmonary temporary support solutions. LivaNova also acquired ImThera and its implantable sleep apnea treatment for $225 million early this year. LivaNova posted profits of $15.1 mill...
Source: Mass Device - Category: Medical Devices Authors: Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker met most of the expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings results. The London-based company posted losses of $111.7 million, or $2.32 per share, on sales of $278.4 million for the 3 months ended December 31, seeing losses grow 61.5% while sales grew 11.5% compared with the same period during the previous year. After adjusting to exclude one-time items, earnings per share were 89¢, just ahead of the 77¢ consensus on Wall Street where analysts were expecting to see sales of $262.7 million. For ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
A patient presents with atrial fibrillation (AF) and a rapid rate. He doesn’t know he is in AF; all he knows is that he is short of breath and weak. The doctors do the normal stuff. He is treated with drugs to slow the rate and undergoes cardioversion. During the hospital stay, he receives a stress test and an implantable loop recorder. He goes home on a couple of medications. The expensive implanted monitor shows rare episodes of short-lived AF, less than 1% of the time. The patient feels great. But here’s the kicker: his doctor recommends an AF ablation. This is nuts. The man has had one episode of AF. He has...
Source: Dr John M - Category: Cardiology Authors: Source Type: blogs
CONCLUSION: The frequency of OSA was found to be significantly higher in patients with MS. In addition to cardiac problems, these patients need to be evaluated also for sleep problems and treated appropriately. PMID: 26901906 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
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