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Source: Mass Device
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Total 467 results found since Jan 2013.
Stryker touts post-market Wingspan stent trial results
Stryker (NYSE:SYK) today released results from the post-market Weave trial of its Wingspan stent system designed for treating intracranial atherosclerotic disease.
Data from the study was presented at the International Stroke Conference, the Kalamazoo, Mich.-based company said.
The Weave trial is a multi-center, prospective, post-market surveillance study which aimed to evaluate rates of stroke or death within 72 hours in patients treated with the Wingspan stent system.
Results from the FDA-mandated trial indicated that patients receiving treatment with the Wingspan stent system had a 2.6% rate of stroke or death, lower ...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Stryker Source Type: news
Viz.ai wins FDA nod automated CT perfusion software
Artificial Intelligence healthcare developer Viz.ai said yesterday it won FDA 510(k) clearance for its Viz CTP computed tomography perfusion image processing and analysis software.
The San Francisco-based company said that the software compliments its current offerings, which include automated large vessel occlusion stroke identification, stroke triage and LVO notification, patient selection, medical image viewing, transport coordination and HIPAA-compliant communications..
“In stroke, good patient outcomes can come down to a matter of minutes. We are proud to offer hospital systems a comprehensive solution that ca...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Software / IT vizai Source Type: news
Terumo ’ s MicroVention wins expanded FDA indications for Sofia cath
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke.
The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used there and in other parts of the world to treat acute ischemic stroke.
“In my clinical experience the unequaled tracking performance and the increased reperfusion capability of the Sofia Catheter make a major difference when treating patients suff...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular MicroVention-Terumo Inc. Source Type: news
J & J ’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device.
The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the company said.
I...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Featured Neurological cerenovus johnsonandjohnson Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 30, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. EnteroMedics registers for $15m follow-on
EnteroMedics registered for a follow-on offering that could bring in as much as $15 million for its Maestro obesity device.
St. Paul, Minn.-based EnteroMedics won FDA approval for the Maestro device in January 2015, following a mixed vote last year aft...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Study challenges CABG mortality benefits over stenting
A new registry analysis study is challenging the benefits of coronary artery bypass grafting over percutaneous coronary interventions using everolimus-eluting stents in patients with diabetes mellitus and multivessel disease.
Results from the 16,000+ patient analysis, published July 8 in Circulation: Cardiovascular Interventions, did not support previous results that suggested that CABG treatments resulted in lower mortality rates than PCI .
The analysis of New York State registry data aimed to examine the comparative effectiveness of the 2 treatments, and results opposed those of the 5-year 2012 Freedom trial. The 1,90...
Source: Mass Device - July 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Diabetes Drug-Eluting Stents Vascular Source Type: news
Medtronic pays $150m for Medina Medical
Medtronic (NYSE:MDT) yesterday said it agreed to pay $150 million to acquire Medina Medical and its embolization coil for treating brain aneurysms.
The Medina device is a self-expanding mesh designed to fill the inside of an aneurysm. Menlo Park, Calif.-based Medina won CE Mark approval in the European Union for the device in September 2014, a month after naming ex-Foundry partner Erik Engelson to be its new CEO. Back in October 2012, the company raised more than $6.5 million in an equity offering that aimed to raise $9.5 million.
Medtronic said it already owned a stake in Medina, meaning a pre-tax gain for its 2n...
Source: Mass Device - September 1, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Neurological Vascular Medina Medical medtronic Source Type: news
Medtronic acquires stent retriever cover-dev Lazarus Effect for $100m
Medtronic (NYSE:MDT) said today it acquired Campbell, Calif.-based stent-retriever cover developer Lazarus Effect for $100 million in an all-cash transaction.
Lazarus’ Cover device is designed to wrap stent retriever devices with a novel nitinol “mesh cover” that folds over the retreiver during clot retrieval and “candy wraps” the stent with the clot contained, Fridely, Minn.-based Medtronic said.
“With this acquisition, Medtronic reinforces its commitment to providing innovative solutions to clinicians and patients fighting stroke. Lazarus Effect’s ‘mesh cover’ techno...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Mergers & Acquisitions Stents Vascular Medtronic Source Type: news
Neuravi launches EmboTrap in Europe
Neuravi said today it launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe.
The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June.
“One of the things Neuravi has done that’s unique to all of our competition is we have launched a huge research effort over the last 5 years in understanding the properties of clots – the cause of ischemic stroke – and we’re going to continue to ...
Source: Mass Device - October 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Cardiovascular Catheters Stents Neuravi Limited Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news
Biotronik launches trial of CLS AF algorithm
Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm.
The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial fibrillation compared to those without the system.
“AF is a huge clinical challenge, affecting over 20 million patients in Europe and the US alone. I am very excited to begin this groundbreaking trial. We hope to demonstrate that the physiological h...
Source: Mass Device - December 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Implants Software / IT Biotronik 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
AliveCor partners with Omron to integrate BP data into Kardia mobile app
AliveCor said today it is partnering with Omron Healthcare to integrate data from its Bluetooth-enabled home blood pressure devices into AliveCor’s ECG Kardia mobile application.
The Mountain View, Calif.-based company said the integration marks the 1st consumer-ready, clinically validated electrocardiogram and blood pressure monitor application which provides heart health information and proactive monitoring.
“Giving patients the ability to monitor two vital heart health statistics for stroke in one place has the opportunity to be life-changing. With this combined data, patients can change their most importa...
Source: Mass Device - September 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) AliveCor Omron Healthcare Source Type: news
Neural Analytics lands $3M NIH grant
Neural Analytics landed a $3 million grant from the National Institutes of Health for the diagnostic and monitoring technology it’s developing for traumatic brain injury and stroke, the company reported. The NIH’s Small Business Innovation Research program funded the grant.
Los Angeles-based Neural Analytics, founded in 2013, develops technology to measure and track brain health, particularly traumatic brain injury, acute ischemic stroke, and dementia. The company is working on a portable ultrasound headset for athletes at risk of concussion.
With the NIH funding, they hope to create a portable device for 1st responder...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diagnostics Funding Roundup Neurological National Institutes of Health (NIH) Neural Analytics Source Type: news
