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Specialty: Medical Devices
Procedure: Heart Transplant

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Total 43 results found since Jan 2013.

First Clinical Experience With the Pressure Sensor–Based Autoregulation of Blood Flow in an Artificial Heart
This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac ou...
Source: ASAIO Journal - October 1, 2021 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Management of Intracranial Hemorrhage During Pulsatile Long-Term Biventricular Support: When Necessity Is the Mother of Invention
We present the case of a 48 year old man with advanced heart failure (INTERMACS 3) and severe biventricular dysfunction who underwent biventricular pulsatile paracorporeal device implantation (Berlin Heart Excor) as a bridge to candidacy. Although on the heart transplantation waiting list, the patient experienced an intracranial hemorrhage, which was successfully managed by switching to a less thrombogenic biventricular assist device (Levitronix Centrimag) using the Excor cannulae, thus enabling temporary withdrawal of antithrombotic therapy. Heart transplant was performed successfully with no significant complications.
Source: ASAIO Journal - October 1, 2021 Category: Medical Devices Tags: Case Reports 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

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

Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology. Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news

What ’s the Big Deal about Data in Medtech?
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things." Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things: "A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming even more ...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news

Bloodstream Infections in Continuous Flow Left Ventricular Assist Device Recipients: Diagnostic and Clinical Implications
Bloodstream infection (BSI) is a common complication of left ventricular assist device (LVAD) support and particularly difficult to treat. The presentation is often variable because of altered physiology and augmentation of cardiac output by the device. We studied LVAD recipients at a single institution. Multivariate logistic and Cox (with time-varying parameters) regression were implemented. Of 212 patients, 58% experienced infections. Driveline infection (DLI) affected 31%, with 60% of them having deep-tissue involvement. Sixty-six patients (31%) suffered from 135 BSIs. Systemic inflammatory response syndrome (SIRS) was ...
Source: ASAIO Journal - November 1, 2019 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

AI is a Big Part of Cleveland Clinic ’s 2019 MIS
CLEVELAND – Two words dominated much of the program agenda for Cleveland Clinic’s 2019 Medical Innovation Summit (MIS) on Tuesday – Artificial Intelligence. From a keynote address from Craig Mundie, Senior Advisor to the CEO, and former Chief Research and Strategy Officer, Microsoft to a session discussing companies with non-traditional approaches to healthcare, the topic of AI was discussed. But is AI just the latest fad in healthcare? Is it fully-defined? And are there real-world examples to look to, to see AI in action? Richard Zane, MD CIO of University of Colorado ...
Source: MDDI - October 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

A Blood Filter Fights Deadly Inflammatory Response
A new blood filtration technology may prove to be life-saving for patients whose normally healthy inflammatory response to injury or illness has gone into overdrive, resulting in fatally high levels of cytokines in their blood. In an interview with MD+DI, Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents Corp., explained that inflammation, and the production of substances called cytokines that drive inflammation, are the body’s natural response to heal injury or infection. But sometimes, the inflammatory response is so severe in such conditions as sepsis and infection, burn injuries, trauma, pancreatitis, li...
Source: MDDI - October 9, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Cardiovascular Source Type: news

Medtronic and Viz.ai Look to Improve Stroke Outcomes with New Alliance
A collaboration between Viz.ai and Medtronic could lead to better outcomes for stroke patients. Through the distribution agreement, San Francisco, CA-based Viz.ai would increase the reach of its artificial intelligence solution for stroke. Viz.ai’s solution identifies suspected large vessel occlusion (LVO) strokes and automatically notify specialists. It could lead patients to get treatment by technologies like Dublin-based Medtronic’s Solitaire revascularization device. “By combining AI software with therapy that works, that’s how we can truly improve...
Source: MDDI - July 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Software Source Type: news

How Did Medtronic ’s HVAD Perform in LATERAL Trial?
Medtronic’s HeartWare HVAD pump system could get a significant boost after performing well in the LATERAL clinical trial. The Dublin-based company presented results from the study at the American Society for Artificial Internal Organs 65th Annual Conference, that showed patients who received the system had 95% freedom from disabling stroke at two years. The medtech giant now plans to launch a global registry to collect additional clinical evidence to further characterize survival, adverse events, and economic benefits of the HVAD System. The HVAD Pump is a left ventricle assist device (LVAD) approved in t...
Source: MDDI - July 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery. With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years. Adverse events were more like...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Medtronic Source Type: news

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

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

ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II. Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said. Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news