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Source: Mass Device
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Total 467 results found since Jan 2013.
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
New Watchman study reports positive data
New data from a study of Boston Scientific (NYSE:BSX)’s Watchman left atrial appendage closure device reports positive results in a study comparing it to warfarin, an anticoagulant drug treatment, in patients with nonvalvular atrial fibrillation.
The 2,406-patient study, published in the Journal of the American College of Cardiology, reported a lower rate of hemorrhagic strokes, unexplained and cardiovascular death and non-procedural bleeding when compared to warfarin.
“I think the fact that we now actually have some good scientific data in the field is terribly important, it has been lacking. But I think we...
Source: Mass Device - June 16, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Stroke 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
FDA clears software using AI to evaluate CT scans for stroke
Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance.
The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones.
“Timely LVO stroke identification and transfer to a specialist hospital that ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Software / IT vizai Source Type: news
TAVI: Study finds low stroke rates with Medtronic’s CoreValve
A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years.
The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days).
Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regulatory/Compliance CoreValve Inc. medtronic Source Type: news
ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates
Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report lowered stroke rates compared to standard treatment.
The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said.
Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Dieg...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials HeartWare International Inc. Medtronic 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
Stryker wins expanded CE Mark for Trevo stent retriever
Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device 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, and follows a similar move in February by the FDA.
“Along with the expanded indication in the U.S., this expanded indication for Trevo in Europe marks a significant milestone in the treatment of stroke patients who suffer from this disease,” neurovascular...
Source: Mass Device - May 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Regulatory/Compliance Stroke Stryker 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
AHA/ASA updates stroke treatment guidelines
The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments.
The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according to a new focused update published in the American Heart Association journal Stroke.
The AHA/ASA said that optimal treatment still lies with the intravenous use of tissue plasminogen activators, used to break down clots, but recommends the u...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. Penumbra Inc. Source Type: news
Study: 3D MRI reveals early stroke risk in diabetics
A new study suggests that diabetes patients may be at a higher risk for stroke due to harboring advanced vascular disease, and that arterial imaging with 3D MRI could help determine stroke risk in diabetes patients.
Data from the study is slated to be presented at the Radiological Society of North America’s annual meeting next week.
“A recent analysis of multiple studies has shown that people with carotid artery narrowing and IPH have a 5- to 6-times higher risk of stroke in the near future compared to people without,” study author Dr. Tishan Maraj of Sunnybrook Research Institute said in prepared remark...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Diabetes Vascular Radiological Society of North America 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
Penumbra touts real-world study results in Penumbra System acute ischemic stroke trial
Penumbra (NYSE:PEN) today released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality.
Results were presented at the International Stroke Conference this week in Los Angeles.
“We thank the Promise investigators for this important contribution to the growing body of global evidence supporting Adapt as a frontline approach for patients with acute ischemic stroke. The Promise study affirms our belief that the Penu...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Penumbra Inc. Source Type: news
J&J’s Biosense Webster buys Coherex Medical and its WaveCrest anti-stroke device
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today that it acquired Coherex Medical for an undisclosed amount.
Salt Lake City-based Coherex makes the Wavecrest anti-stroke device, which is designed to occlude the heart’s left atrial appendage to prevent blood clots from forming that could cause stroke.
“The addition of the Coherex WaveCrest system complements our comprehensive portfolio of therapeutic solutions for patients suffering from atrial fibrillation who not only suffer from reduced quality of life but also face a significantly greater risk of a stroke,” group chairman Shlomi...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Mergers & Acquisitions BioSense Webster Inc. Coherex Medical Johnson & Johnson Source Type: news
