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Source: Mass Device
Condition: Disability
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Total 24 results found since Jan 2013.
FDA approves Concentric Medical ’ s Trevo clot retrievers
The FDA said today it granted expanded approval to 2 Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.
The indications expand the previously won clearance for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who could not receive t-PA or for patients who didn’t respond to t-PA therapy.
“This is the first time FDA has allowed the use of these devices alongside...
Source: Mass Device - September 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Catheters Food & Drug Administration (FDA) Regulatory/Compliance Concentric Medical Inc. Stryker Source Type: news
Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based c...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Surgical Nico Corp. Source Type: news
ReWalk inks collab deal with Harvard to develop “soft” exosuit
ReWalk Robotics (NSDQ:RWLK) said today it inked a collaborative research with Harvard’s Wyss Institute to develop a lightweight “soft suit” exoskeleton system for lower limb disabilities.
The collaboration looks to design a suit to treat stroke, multiple sclerosis and mobility limitations for the elderly as well as other applications.
Through the agreement, ReWalk will pay Harvard in quarterly installment payments to fund the research, with reports from the research being relayed between the groups on a regular basis.
ReWalk Robotics will be able to negotiate with Harvard to license new inventions create...
Source: Mass Device - May 17, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Prosthetics Harvard University ReWalk Robotics Wyss Institute Source Type: news
Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug alteplase, according to a meta-analysis of 4 previous trials of the device.
The transcatheter Solitaire device uses a stent-like device to trap and retrieve a blood clot in the brain in cases of ischemic stroke. Researchers from the 4 trials – Swift Prime, Revascat, Extend-IA and Escape – pooled their data to examine the results from 787 patients, randomized to either thrombectomy with the Solitaire device (401) or stan...
Source: Mass Device - February 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Neurological Vascular Medtronic Stroke Source Type: news
Axinesis wins CE Mark for robotic rehab device
Axinesis said today it won CE Mark approval in the European Union for its REAPlan medical interactive robot device designed to rehabilitate impaired upper limbs in stroke victims and children with cerebral palsy.
The Belgian company’s REAPlan combines robotics and “therapeutic gaming” to improve rehabilitation of impaired upper limbs, and offers automated personalized assistance of arm movements, Axinesis said.
“This is an important milestone in our mission to provide state-of-the-art technologies dedicated to the rehabilitation of brain-injured patients. The continual requests from customers for pr...
Source: Mass Device - February 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Regulatory/Compliance Robotics Axinesis Source Type: news
Paralyzed California man re-learns to walk via computer
(Reuters) — For paraplegic Adam Fritz, the thrill of the computer-assisted first steps he took five years after being paralyzed in a motorcycle crash came only after he was unhooked from the system that enabled him to walk briefly in a bioengineering lab.
During the experiment itself, Fritz recounted, he had to keep his mind focused entirely on placing one foot in front of the other as his brain waves were translated by a computer algorithm into impulses that bypassed his severed spinal cord and activated his legs.
“If you break your concentration, it wouldn’t work anymore,” he told Reuters shortly aft...
Source: Mass Device - September 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: Research & Development Source Type: news
Study: Manual thrombectomy increases stroke risk
Routine percutaneous coronary interventions with manual thrombectomies increase the risk of stroke compared to PCI alone, according to a new substudy published last month.
The substudy, published online already and set to go to print in the European Heart Journal, examined a 10,058-patient cohort from the earlier Total study of PCI and manual thrombectomies to better understand the increase in stroke rate.
The new analysis reported that the stroke difference was evident in as little as 48 hours, with 15 thrombectomy patients reporting an event versus 5 treated with only PCI. The overall risk was still low however, with a 0...
Source: Mass Device - July 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials European Heart Journal Source Type: news
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices.
The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left atrial appendage occlusion for patients with atrial fibrillation.
The groups suggests that the use of LAA occlusion devices, such as Medtronic‘s (NYSE:MDT) Watchman device, may lower the risk of stroke in se...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials American College of Cardiology American Heart Assn. Heart Rhythm Society Society for Cardiovascular Angiography & Intervention Source Type: news
More good news for stent thrombectomy
Two more clinical studies, sponsored by Medtronic, show the benefit of stent thrombectomy in treating strokes.
A pair of clinical trials comparing treatment with anti-stroke drugs and stent thrombectomy with drug therapy alone showed reduced disability in stoke patients, bringing more good news for stent thrombectomy device makers.
Medtronic, New England Journal of MedicineNews Well, Clinical Trials, Strokeread more
Source: Mass Device - April 17, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news
