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Condition: Thrombosis

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Total 69 results found since Jan 2013.

Abbott ’s Amplatzer Stroke Reduction Data Is Strong at EuroPCR
Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occlusion device has been shown at one year to reduce stroke by 57% as compared to the predicted stroke risk. The data also showed it was able to make this reduction without the need for lifetime blood thinners.  The Abbott Park IL-based company released the data at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions in Paris, and simultaneously published in EuroIntervention. More than 1,078 patients suffering from atrial fibrillation (Afib) were in the study with one-year-follow up. “The Amulet is a devi...
Source: MDDI - May 24, 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

Doctors Beware: Abbott & #039;s HeartMate 3 Has a Safety Problem
Just when it seemed the HeartMate 3 was gaining momentum, Abbott warned physicians that outflow graft twisting may occur after the left ventricular assist device (LVAD) is implanted. The problem can trigger a persistent low-flow alarm that may signal a potential safety risk to patients, such as blood flow or clotting. The Abbott Park, IL-based company has not recalled any of the devices from patients or hospitals, but there have been 32 reports of outflow graft twisting (an incidence rate of 0.72%), including reports of low blood flow, clotting, and three patient deaths. No devices are being recalled from patients or hosp...
Source: MDDI - May 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Implants Source Type: news

Abbott Gains on Medtronic in LVAD Market
Abbott Laboratories said late-breaking clinical trial data from its MOMENTUM 3 clinical study shows its HeartMate 3 Left Ventricular Assist Device (LVAD) has improved survival and lowered rates of stroke and pump thrombosis. The Abbott Park, IL-based company released the data during the American College of Cardiology’s 67th Annual Scientific Sessions this past weekend. Data from MOMENTUM 3 was also published in the New England Journal of Medicine and showed patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared with 76.2% for those with the HeartMate II LVAD. Pump thrombosis rates remained ...
Source: MDDI - March 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

ACC ’ 18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session. More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years. The two-year cohort met its primary endpoint, achieving 77.9% event...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Wall Street Beat Abbott Aetna AliveCor iRhythm Technologies Inc. Jan Source Type: news

FDA clears Medtronic ’ s Riptide clot aspiration device
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Riptide clot aspiration device for treating ischemic stroke. The Riptide device is designed to retrieve blood clots via the Arc catheter to restore blood flow to the brain. The clearance covers patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of first symptoms, including patients who can’t take or failed off of anti-clotting drugs. Medtronic called the Riptide design “a foundational platform” for other aspiration catheters it’s developing. The Fridley, M...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Medtronic Stroke Source Type: news

LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or ope...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news

TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke. Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes. Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Studies support anti-stroke PFO closure devices from Abbott, Gore
Sykes and Clark; licensee BioMed Central Ltd. A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients. Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurr...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news

FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations. The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use of the product could cause serious adverse health consequences or death. The 3D Revascularization device is designed to restore blood flow or remove blood clots in blood vessels in the brain during acute ischemic stroke in patients who are ineligible or fail...
Source: Mass Device - July 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Neurological Recalls Vascular Penumbra Inc. Source Type: news

Permanent Atrial Fibrillation and 2 Year Clinical Outcomes in Patients with a Left Ventricular Assist Device Implant
Atrial fibrillation (AF) may increase the risk of thromboembolic (TE) complications in patients with left ventricular assist devices (LVADs). In a single-center study, we investigated 205 patients with sinus rhythm (SR group) and 117 patients with AF (AF group). Our main read outs were 2 year overall survival (primary end point), perioperative right heart failure (RHF), and 2 year freedom from stroke, pump thrombosis, and gastrointestinal bleeding (secondary end points). Oral anticoagulation was performed with phenprocoumon (international normalized ratio target range: 2.3–2.8) and aspirin (100 mg/day). Propensity scor...
Source: ASAIO Journal - June 29, 2017 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Ventricular assist devices for the failing univentricular circulation.
Authors: Buratto E, Shi WY, Ye XT, Konstantinov IE Abstract INTRODUCTION: Improved survival following single ventricle palliation has led to a large population of patients with a Fontan circulation, many of whom will eventually develop Fontan failure. Many of these patients will require heart transplantation. However, more than half of these patients have Fontan failure despite preserved ventricular function. Increasing experience with ventricular assist devices (VAD) in children has paved the way for VAD support in those with failing univentricular circulation. Areas covered: The use of VADs to support the failing...
Source: Expert Review of Medical Devices - May 24, 2017 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

MassDevice.com +5 | The top 5 medtech stories for March 17, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. GlucoMe tackles connected diabetes management with acoustic data transmission The Centers for Disease Control & Prevention predict that by 2050, if current trends continue, 1 in 3 adults in the U.S. will have diabetes. The d...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

Endovascular Stenting of a LVAD Outflow Graft Thrombosis
This report highlights the importance of simultaneous prevention of stroke using filter devices in the common carotid arteries.
Source: ASAIO Journal - December 30, 2016 Category: Medical Equipment Tags: Case Reports Source Type: research