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Specialty: Medical Devices
Condition: Hemorrhagic Stroke
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Total 83 results found since Jan 2013.
FDA warns on SentreHeart’s Lariat anti-stroke device
The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths.
The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots from forming there that could later cause stroke in patients with atrial fibrillation. The FDA said the reports from its Manufacturer & User Facility Device Experience database included complications from the Lariat procedures that included lacerati...
Source: Mass Device - July 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance SentreHeart Stroke Source Type: news
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation.
Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology.
In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
MedyMatch looks to future of stroke detection with AI platform launch
Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain bleeds is now available for research.
The development is a milestone for the company, but is only the 1st stop for the platform, CEO Gene Saragnese told MassDevice.com in an interview.
“What we’ve done at MedyMatch is develop not just an algorithm, but an AI platform which looks at the entire patient – that is to say, the full richness of 3D imaging plus other patient attributes – to allow us, firstly, to understand whether that person is hemorrhagic st...
Source: Mass Device - December 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Software / IT MedyMatch 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
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
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
Diagnostic value of coagulation index and serum inflammatory cytokines in hemorrhagic stroke patients with pulmonary infection in the sequelae stage
CONCLUSION: FIB, D-D, PLT, and IL-17 levels could be used for pulmonary infection diagnosis in the sequelae stage of hemorrhagic stroke patients.PMID:37661900 | DOI:10.3233/THC-230345
Source: Technology and Health Care - September 4, 2023 Category: Medical Devices Authors: Yanxia Wang Yaqing Li Xiaoqing Wang Zhancong Niu Lixia Zhou Source Type: research
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
