Filtered By:
Source: Mass Device
Condition: Disability
This page shows you your search results in order of relevance.
Order by Relevance | Date
Total 24 results found since Jan 2013.
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
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
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
ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts.
The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects.
“It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news
FDA clears Imperative Care ’ s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters.
Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood-vessel conditions, the company said.
“Recognizing the significant need to elevate the standard of patient therapeutics in stroke, Imperative Care was founded to become the comprehensive stroke company innovat...
Source: Mass Device - January 24, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Research & Development imperativecare 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
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
Stryker wins expanded FDA indications for Trevo thrombectomy device
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.
The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company.
“The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Vascular Stryker Source Type: news
Stryker touts NEJM publication of Trevo thrombectomy device trial results
Stryker (NYSE:SYK) yesterday released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke.
Results from the trial were published in the New England Journal of Medicine, the Kalamazoo, Mich.-based company said.
“By quadrupling the size of the therapeutic time window, the consequence of Dawn is that many more patients with large vessel occlusion stroke have the potential to be treated with mechanical thrombectomy. Dawn validates the physiological, rather than time-based approach to patient selection for endovascular therapy,” co...
Source: Mass Device - November 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Stryker Source Type: news
Medtronic touts Solitaire stent retriever data
Medtronic (NYSE:MDT) yesterday touted data presented at the International Stroke Conference on its Solitaire stent retriever from 4 studies. The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing blood clots that cause acute ischemic stroke.
The Stratis AIS study evaluated the impact of treatment delays and patient outcomes when patients were treated with the Solitaire stent retriever and intravenous tissue plasminogen activator. Of the 984 enrolled patients, 64% were treated with the device and IV-tPA, while 36% were treated with the stent retriever al...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Neurological Wall Street Beat Medtronic Source Type: news
Stryker ’ s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.
Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA.
The federal watchdog reviewed the order, and said that on September 2 it issued an order to reclassify the device types, given the generic name of neurovascular mechanical thrombectomy devices for ischemic stroke treatment, as Class II.
In relabeling the devices, the FDA identified 5 possible risks, including adverse tissue rea...
Source: Mass Device - December 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Concentric Medical Inc. Stryker Source Type: news
ReWalk Robotics expands ReStore soft exo-suit trial
ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers.
The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.
Enrollment for the company’s multi-center study is ongoing. The five centers involved in the trial include the Shirley Ryan ...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Robotics Wall Street Beat ReWalk Robotics 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
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
Study: Delaying thombectomy, even for minutes, can lead to lifelong consequences
Delaying endovascular thrombectomy treatment for patients with acute ischemic stroke can take time off of patient’s lives and cost hospitals extra, according to a new study reported by Medscape.
Results from the study were presented by Dr. Wolfgang Kunz of Munich, Germany’s Ludwig Maximilian University during the 11th World Stroke Congress.
Every hour of delay within the first six resulted in, on average, a loss of approximately 0.6 quality-adjusted life years, or approximately 7.7 months of disability-free life, according to the report.
Beyond patient outcomes, every hour of delay also reduces the economic value o...
Source: Mass Device - October 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Source Type: news
