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Specialty: Medical Devices
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Total 82 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
A Standardized Approach Improves Outcomes of Extracorporeal Membrane Oxygenation for Postcardiotomy Shock
This study suggests that a standardized approach with a dedicated ECMO team is feasible and may improve outcomes of PCS.
Source: ASAIO Journal - October 1, 2021 Category: Medical Devices Tags: Adult Circulatory Support 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
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.â€
Abbo...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance 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
Sky Medical Technology Nabs FDA Clearance for VTE Device
Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism.
The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients.
Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko works by gently stimulating the common peroneal nerve, activating the calf and foot muscle pumps, re...
Source: MDDI - October 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Forest Devices Is Crushing It This Year
Forest Devices added another feather to its cap at The MedTech Conference in Boston, MA where the startup won the MedTech Innovator 2019 Showcase and received a $350,000 grand prize award.
Forest is developing AlphaStroke, the first device designed to detect a stroke in any environment. The portable device uses electroencephalogram monitoring and machine learning to diagnose large vessel occlusions and other stroke subtypes, enabling first responders to triage patients to proper stroke centers. In 2018, the Pittsburgh, PA-based company closed an oversubscribed see...
Source: MDDI - October 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Abiomed Hits TCT 2019 Running with Compelling Data and New Approval
Abiomed certainly brought its A-game to the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) conference- being held now and throughout the weekend. The Danvers, MA-based company came armed with the news of a newly-approved device and data from its PROTECT III trial, an ongoing prospective, single-arm FDA post-market study for the Impella 2.5 and Impella CP in high-risk PCI.
Abiomed, which was named one of the top 25 M&A targets in medtech, said an interim analysis of 898 patients from the PROTECT III trial demonstrated a reduction in the primary endpoint of death, stroke, myocardial infarction, and repeat pr...
Source: MDDI - September 26, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Neural Analytics Continues Its Journey with $22M Financing
When Neural Analytics won CE mark and a Nod from FDA for its ultrasound guidance device last year, that was only the start of the company’s journey. The Los Angeles-based company is now on a quest to launch its neurocare solution in the U.S. and develop a strategy to help push adoption rates for the technology.
The company kicked off the latest part of its journey with a $22 million financing from the sale of Series C shares led by Alpha Edison. Neural Analytics has also issued warrants to purchase stock in connection to the financing.
Leo Petrossian, PhD., Co-Founder and CEO of Neural Analytics said the...
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Bet Your Toilet Seat Can & #039;t Do This!
Every now and then we come across a technology that just begs the question: How on Earth did they think of that? Case in point, a toilet seat designed to detect heart failure by measuring a patient's biometrics during "natural" processes.Â
A team of researchers at Rochester Institute of Technology (RIT) are responsible for the idea, which is intended to lower hospital readmission rates by alerting doctors of a patient's deteriorating cardiovascular condition before the patients even realize they have symptoms. The idea is for hospitals to buy the seats and issue them to heart failure patients after ...
Source: MDDI - March 20, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular 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
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Predict and Prevent: The Emergence of Real-Time Sensor-Based Care
Technology industry veteran Eran Ofir knows there is a lot of luck involved in successfully bringing a new device, especially one designed to create a new treatment vector, to market.
Ofir is the CEO and co-founder of New York-based Somatix, which uses wrist-worn sensor data to dynamically monitor a person's situation. Used in conjunction with cloud-based computing resources and a communications device, the technology is capable of dynamically helping someone quit smoking, through detecting smoking gestures and automatically sending messages to the user encouraging them not to smoke.
"We got lucky on two fronts," Ofir said...
Source: MDDI - December 19, 2018 Category: Medical Devices Authors: Greg Goth Tags: Digital Health Source Type: news
