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Specialty: Medical Devices
Condition: Thrombosis
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Total 69 results found since Jan 2013.
Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer
Corvia Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option.
Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria, according to Corvia’s website.
Tewksbury, Mass.-based Corvia said the 100-patient Reduce Lap-HF I study is a prospective, multicenter, randomized controlled trial. The primary ...
Source: Mass Device - March 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Mergers & Acquisitions Corvia Medical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
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. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Outcomes of Various Treatment Strategies for Patients with Continuous-Flow Ventricular Assist Device Thrombosis: A Retrospective Analysis
Pump thrombosis is associated with high morbidity and mortality in patients with a continuous-flow left ventricular assist device. Although it has been defined clearly, the diagnosis and treatment of this complication still remain controversial. Between 2010 and 2014, 163 consecutive patients (mean age: 50.7 ± 13 years, 84% males, median duration of support: 277 (2–1077) days) were implanted a continuous-flow left ventricular assist device. Prospectively collected data of all patients who had at least one pump thrombosis event have been analyzed, retrospectively. Twenty-one pump thrombosis events were observed in 15...
Source: ASAIO Journal - August 27, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Associations of Preimplant Red Blood Cell Distribution Width with Clinical Outcomes Among Individuals with Left Ventricular Assist Devices
In conclusion, higher preimplant RDW is independently associated with an increased risk of postimplant mortality and infection. Future studies are needed to understand the prognostic ability of RDW and to understand the biologic mechanism underlying this association.
Source: ASAIO Journal - November 1, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots.
The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news
Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patient’s blood and release blood-thinning drugs to prevent dangerous blood clots, or thrombosis. The team’s work was published in Advanced Materials.
When blood clots disrupt the flow of blood throughout the body, the result can cause pulmonary embolism, heart attack or stroke. Conventional treatment requires patients to regularly test their blood to ensure proper dosages of blood thinners such as Heparin. I
f a patient uses too small a dose, it may not prevent ...
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 30, 2016
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. Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patientâ...
Source: Mass Device - November 30, 2016 Category: Medical Equipment Authors: MassDevice 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
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
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
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
Accelerometer Detects Pump Thrombosis and Thromboembolic Events in an In vitro HVAD Circuit
Pump thrombosis and stroke are serious complications of left ventricular assist device (LVAD) support. The aim of this study was to test the ability of an accelerometer to detect pump thrombosis and thromboembolic events (TEs) using real-time analysis of pump vibrations. An accelerometer sensor was attached to a HeartWare HVAD and tested in three in vitro experiments using different pumps for each experiment. Each experiment included thrombi injections sized 0.2–1.0 mL and control interventions: pump speed change, afterload increase, preload decrease, and saline bolus injections. A spectrogram was calculated from the acc...
Source: ASAIO Journal - August 28, 2018 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
Low-Dose Prothrombin Complex Concentrate in Patients with Left Ventricular Assist Devices
We describe two cases of warfarin reversal with low-dose 4-factor PCC (4F-PCC) in two different LVAD patient scenarios. Low-dose 4F-PCC was administered to one patient with a Heart Mate II (HM II) LVAD, international normalized ratio (INR) of 4.7 on admission and in need of an urgent procedure. He received approximately 16 units/kg of 4F-PCC with reversal of his INR to 2.3 within 45 minutes. The second patient also had a HM II LVAD and presented with a right occipital intraparenchymal hemorrhage and subdural hematoma with an INR of 3.7. He received approximately 11 units/kg of 4F-PCC with INR reversal to 1.6 within 1 hour....
Source: ASAIO Journal - January 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research
Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation
This study provides further insight into our understanding of the pathogenesis of LVAD thrombosis, addressing SMPA as a relevant key factor associated with thrombotic complications. With the PAS assay, we have identified a reliable biomarker to promote tailored pharmacological therapy for the prevention of thromboembolic events in patients with LVADs.
Source: ASAIO Journal - April 30, 2019 Category: Medical Devices Tags: Case Reports Source Type: research
Management of Antiplatelet Therapy During Continuous-Flow Left Ventricular Assist Device Support After Thrombotic Hemorrhagic Events
Hemorrhagic or thrombotic events are common complications in heart failure patients with continuous-flow left ventricular assist device (CF-LVAD) support. Aim of this study is to investigate the effect of change in antiplatelet therapy after thrombotic or hemorrhagic events in patients with CF-LVAD support. A total of 231 CF-LVAD patients were included in this study. Patients with CF-LVAD were categorized into three groups: (1) high antiplatelet regimen as control group (aspirin [ASA] 325 mg; n = 115), (2) low antiplatelet regimen (ASA 81 mg; n = 82), started after hemorrhagic complications, and (3) double antiplatelet...
Source: ASAIO Journal - September 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
