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Specialty: Medical Devices
Condition: Ischemic Stroke
Management: Hospitals

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Total 38 results found since Jan 2013.

Neurologic Outcomes After Extracorporeal Cardiopulmonary Resuscitation: Recent Experience at a Single High-Volume Center
This study describes the recent ECPR experience at the University of Maryland Medical Center from 2016 through 2018, with attention to neurologic outcomes and predictors thereof. The primary outcome was dichotomized Cerebral Performance Category (≤2) at hospital discharge; secondary outcomes included rates of specific neurologic complications. From 429 ECMO runs over 3 years, 57 ECPR patients were identified, representing an increase in ECPR utilization compared with 41 cases over the previous 6 years. Fifty-two (91%) suffered in-hospital cardiac arrest, and 36 (63%) had an initial nonshockable rhythm. Median low-flow ti...
Source: ASAIO Journal - February 1, 2022 Category: Medical Devices Tags: Clinical Critical Care Source Type: research

In-hospital Outcomes of Left Ventricular Assist Devices (LVAD) Patients Undergoing Noncardiac Surgery
An increasing number of stage D heart failure patients are supported with left ventricular assist devices (LVADs), and the management of LVAD patients who require noncardiac surgery (NCS) presents unique challenges. Using the 2010–2014 National Inpatient Sample, we identified all adult cases of LVAD patients undergoing noncardiac surgeries using ICD-9-CM codes. We estimated inpatient mortality, bleeding complications, stroke, length of stay (LOS), and cost of hospitalization of the admissions related to NCS using mixed effects logistic and linear mixed regressions, respectively. A total of 30,323 patients with LVADs unde...
Source: ASAIO Journal - February 1, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Plugs for left atrial appendage occlusion: an overview of available devices.
Authors: Obeid S, Nietlispach F, Meier B Abstract INTRODUCTION: Approximately one third of all ischemic strokes and the ensuing health and economic burden can be attributed to the presence of atrial fibrillation (AF). The global prevalence of AF continues to rise, thus making it by far the most common diagnosed cardiac arrhythmia. Percutaneous left atrial appendage (LAA) occlusion or obliteration has been developed to protect from the occurrence of stroke in patients with nonvalvular AF. AREAS COVERED: We address the characteristics and techniques for implantation as well as some clinical registries and randomi...
Source: Expert Review of Medical Devices - October 20, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Ischemic Stroke and Intracranial Hemorrhages During Impella Cardiac Support
Impella is a percutaneously placed, ventricular assist device for short-term cardiac support. We aimed to study acute neurologic complications during short-term cardiac support with Impella. We reviewed prospectively collected data of 79 consecutive persons implanted with Impella at a single tertiary center. Acute neurologic events (ANE) were defined as ischemic strokes or intracranial hemorrhages. Among those with ANE, specific causes of ischemic and hemorrhagic events were collected and discussed. Of 79 persons with Impella with median 8 days of support (range 1–33 days), six (7.5%) developed ANE at a median of 5 days ...
Source: ASAIO Journal - July 30, 2020 Category: Medical Devices Tags: Case Report Source Type: research

RapidAI is Set to Acquire EndoVantage for an Undisclosed Sum
M&A is still a thing during the COVID-19 Pandemic. Advanced stroke imaging firm, RapidAI is acquiring EndoVantage, developer of the Find, Track, and Treat comprehensive cerebral aneurysm management platform. Menlo Park, CA-based RapidAI said this acquisition can help it expand its scope, from ischemic stroke to hemorrhagic stroke and now aneurysm. EndoVantage was started at Mayo Clinic and Arizona State University has developed a powerful award-winning computational platform that provides comprehensive cerebral aneurysm management, automating the entire workflow from initial assessment, growth monitoring, to treatment ...
Source: MDDI - June 10, 2020 Category: Medical Devices Tags: Business Cardiovascular Source Type: news

ICDs Have Come a Long Way in 40 Years
Michel Mirowski and his colleagues gave the field of implantable cardioverter-defibrillators (ICDs) a pretty good start, but what's more impressive is how far the technology has advanced since that first human ICD implant in February 1980. In the past 40 years we've seen ICDs become dramatically smaller, longer lasting, more capable, more personalized, subcutaneous (non-transvenous), and even MRI-firendly. And that's not to mention the advanced data connectivity and monitoring capabilities that the latest technologies offer. So without further ado, let's take a look at the current ICD landscape and the companie...
Source: MDDI - February 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke." In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.” Abbo...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview 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

Terumo ’ s MicroVention wins expanded FDA indications for Sofia cath
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke. The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used there and in other parts of the world to treat acute ischemic stroke. “In my clinical experience the unequaled tracking performance and the increased reperfusion capability of the Sofia Catheter make a major difference when treating patients suff...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular MicroVention-Terumo Inc. Source Type: news

J & J ’ s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients ...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news

Cerenovus Receives FDA Nod for EMBOTRAP II
Johnson & Johnson’s Cerenovus unit has received an FDA nod to market the EMBOTRAP II Revascularization Device. The device is a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke. The EMBOTRAP II Device is designed to rapidly restore blood flow by gripping and retrieving clots within the neurovasculature, with minimal compression, protecting against further complications. The device is indicated for use within eight hours of stroke symptom onset. In the ARISE II study, which was submitted as part of the 510(k) application to FDA, neuroint...
Source: MDDI - May 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

HRS 2018: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis. There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study. Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Boston Scientific HRS 2018 Source Type: news

HRS 2018 Roundup: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis. There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study. Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Apple Bardy Diagnostics Boston Scientific Fitbit HRS 2018 Impulse Dynamics Imricor Medical Systems Inc. medicalgorithmics Medtronic Preventice samsung 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