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Source: Mass Device
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Total 237 results found since Jan 2013.
Chinese dev LifeTech wins CE Mark for LAA closure device
Chinese developer LifeTech Scientific said today it won CE Mark approval in the European Union for its LAmbre left atrial appendage closure system, touting it as the 1st Chinese-developed LAA closure system to receive such approval.
The LAmbre system is designed for the closure of the LAA percutaneously through a small 8 to 10 Fr sheath, and consists of a distal umbrella and a proximal cover disc connected by a short sleeve, LifeTech said. The device is fully recapturable and repositionable, the company added.
“We are proud of the CE mark of the first LAA closure system from China and confident that our LAmbre LAA ...
Source: Mass Device - June 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance LifeTech Scientific Corp. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 15, 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.
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5. Biotronik wins CE Mark for Magmaris bioresorbable scaffold
Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease.
Data from the Biosolve-II trial of the ...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Silk Road touts TCAR study data
Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent.
The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in the wake of its FDA sign-off last October. Investigators from Massachusetts General Hospital and elsewhere presented their findings during the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which was held June 8-11 in Natio...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Catheters Clinical Trials Stents Vascular Silk Road Medical Inc. Source Type: news
FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune.
The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
In a closer vote, the same panel ruled 11-5 that the device’s benefits o...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news
HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting.
St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemak...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 21, 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.
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5. US gov’t delays CMS hospital rating system
The Obama Administration is holding off from publishing new hospital-quality ratings over concerns raised by healthcare providers and Congress over the methodology of the ratings sys...
Source: Mass Device - April 21, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Study: Medtronic touts increased AF detection with Reveal Linq system
Medtronic (NYSE:MDT) today released 1-year results from a study of patients who experienced a cryptogenic stroke, claiming that its Reveal Linq insertable cardiac monitor was able to detect atrial fibrillation at a greater rate than previously reported in a 2014 clinical trial.
Results from the real-world study were presented at the 68th American Academy of Neurology’s annual meeting in Vancouver, Canada.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest and is indicated for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain ...
Source: Mass Device - April 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Patient Monitoring Medtronic Source Type: news
Exploring the science behind the marathon runner
Running the Boston Marathon takes months of training, and it can take a toll on elite marathoners and novice athletes alike. Vector checked in with some of the experts in the Boston Children’s Hospital’s Sports Medicine Division to learn more about how science can aid marathon runners, prevent injury and illness and facilitate recovery.
Chocolate milk: A no-brainer for maximizing recovery
The most rapid way to maximize recovery after an endurance run is to consume carbohydrates in a 4:1 ratio within 30 to 60 minutes of completing the marathon. The enzyme glycogen synthase is most active within this time frame; it syn...
Source: Mass Device - April 18, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Vector Blog Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 13, 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.
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5. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.
“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMo...
Source: Mass Device - April 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Biotronik Source Type: news
PathMaker and Feinstein Inst launch MyoRegulator spasticity trial
PathMaker Neurosystems said today it paired with the Feinstein Institute and Northwell Health to launch an IRB-approved clinical trial of its MyoRegulator device designed to treat muscle spasticity.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.
“Initiating our company’s 1st formal human clinical trial represents a significant milestone in our strategy to rapidly and efficiently bring to market an entirely new, non-invasive approach to treating spasticity. We are...
Source: Mass Device - April 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blog PathMaker Neurosystems Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 5, 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. Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Results from the Propel all-comers trial comparing Medtronic‘s Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Edwards Lifesciences hits all-time high on Sapien 3 study
Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend.
Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lan...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Wall Street Beat American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients).
Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Medtronic launches CoreValve Evolut R trial in low-risk patients
Medtronic (NYSE:MDT) said yesterday that it launched another clinical trial for its CoreValve Evolut R replacement heart valve, aiming to win an expanded indication for low-risk patients.
The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
The primary endpoint is all-cause mortality or disabling st...
Source: Mass Device - April 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Source Type: news
