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Total 237 results found since Jan 2013.
Nico launches trial for brain surgery shunt
Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages.
The trial will examine the procedural safety as well as economic and functional benefit of early surgical removal of intracerebral hemorrhages using its BrainPath Approach system.
“Our initial clinical results with this approach for early clot removal have been exciting and provided a wake-up call to what has been missing in hemorrhagic stroke care,” trial principal investigator Dr. Daniel Barrow said in a press release.
Indianapolis, I...
Source: Mass Device - January 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Nico Corp. Source Type: news
Amnis launches 1st-in-human study of Golden Retriever thrombectomy device
Israeli vascular-focused bio-engineering company Amnis Therapeutics said today it won Swedish approval for a 1st-in-human clinical trial of its Golden Retriever neuro thrombectomy device.
The trial will be led by neurosurgeon Dr. Tommy Andersson, and is slated to enroll 60 acute ischemic stroke patients with large intracerebral vessel occlusion, the company said.
“We are happy to start the clinical phase of testing the Golden Retriever, which is the last phase, prior to receiving a CE Mark. We believe that the Golden Retriever’s attributes, suggest significant advantages over existing products for neuro throbem...
Source: Mass Device - January 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Regulatory/Compliance Vascular Amnis Therapeutics Source Type: news
Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute.
Data from the studies was presented last month at the 44th annual Veith Symposium in New York.
The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA.
Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, which examined the use of ...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
Siemens Healthineers inks deal with N.Y. provider Northwell Health
Siemens Healthineers (NYSE:SI) said today it inked a 4-year research deal with N.Y. state healthcare provider Northwell Health.
The 2 parties aim to develop research projects evaluating clinical effectiveness and outcomes using data analytics-based population health evidence. As part of the 4-year partnership deal, Siemens Healthineers will also provide full-time employees who will work jointly with Northwell Health.
“This partnership is first-of-its-kind for both Siemens Healthineers and Northwell Health to collaborate on research that could potentially define care pathways for various populations in the future. We...
Source: Mass Device - December 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Clinical Trials Research & Development Siemens Healthineers Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 30, 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. Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patientâ...
Source: Mass Device - November 30, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 16, 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. St. Jude Medical’s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical acquired when it paid $3 billion for Thoratec last year proved superior to ...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots.
The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news
FDA expands indication for Medtronic ’ s Solitaire stent retriever
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever.
The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is designed to remove clots from brain arteries using a micro-sized catheter.
“This expanded indication for the Solitaire device demonstrates Medtronic’s ongoing dedication to significantly improving the lives of stroke patients,”...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Stroke Source Type: news
Computer-brain interface helps locked-in patient communicate, albeit slowly
(Reuters) – Doctors in the Netherlands say they have successfully tested an implantable computer-brain interface that allowed the mind of a “locked-in” patient to spell messages at the rate of two letters per minute.
The system was tested on a 58-year-old woman in the late stages of amyotrophic lateral sclerosis, or ALS. Unable to speak or move her muscles, she had to identify the letters by imagining that she was moving her right hand. Previously, her only method to communicate was through eye movements and blinks.
“We’ve built a system that’s reliable and autonomous that works at home ...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: Neurological Source Type: news
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
SanBio touts 1-year data on stem cell transplant for stroke
SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients.
The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients  suffering with chronic impairment following an ischemic stroke.
SanBio presented interim results from the study at the American Congress of Rehabilitation Medicine Conference last week, and claims that the study is the 1st of its kindÂ...
Source: Mass Device - November 4, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Research & Development Stem Cells SanBio Inc Source Type: news
TCT 2016: Stents, stents, stents on Day 1
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front.
Stents equivalent to CABG
Drug-eluting stents are as effect as coronary artery bypass grafts in treating patients with blocked left main coronary arteries, according to a study that compared Abbott‘s (NYSE:ABT) Xience DES with CABG i...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Stents TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
Study is 1st to quantify ‘ brain hacking ’ tDCS fields
Researchers have successfully visualized the field of effect of transcranial direct current stimulation using a novel magnetic resonance imaging technique, according to a new study.
Results from the study were published in the journal Nature last month.
Therapeutic procedures with tDCS are used to apply sustained changes in motor evoked potentials, and the technique has been shown to improve symptoms of neurologic and psychiatric disorders including epilepsy, Parkinson’s, depression, stroke and chronic pain.
The use of tDCS has even been shown to improve learning, modulate working memory and invoke other cognitive benefi...
Source: Mass Device - October 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Neuromodulation/Neurostimulation Source Type: news
Phenox touts pREset thrombectomy device trial data
German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits.
The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety and long-term outcomes. The trial included patients with acute proximal occlusions of major cerebral vessels in both the anterior and posterior circulation, Bochum, Germany-based Phenox said.
Results indicated a 62.5% rate of positive clinical outcomes with fr...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Catheters Clinical Trials Neurological phenox Source Type: news
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes.
“Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news
