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Artificial intelligence accurately predicts stroke risk
[Image from unsplash.com]Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham. Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient having each. The results showed that the artificially intelligent algorithms were significantly more accurate at predicting cardiovascular disease than the regular medical models. Get the full story on our sister...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Research & Development AI artificial intelligence cardiovascular disease heart disease machine learning algorithms Stroke University of Nottingham Source Type: news

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

ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates
Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report  lowered stroke rates compared to standard treatment. The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said. Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Dieg...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials HeartWare International Inc. Medtronic 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

FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System. Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2. The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia 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

SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device. In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction. SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebr...
Source: Mass Device - August 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia 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

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

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

FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said. AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news

Investors See Big Opportunity in AI
Artificial Intelligence could be the next big market in medtech that investors flock to. Earlier this week, Viz.ai proved that this might just be the case as it raised about $21 million in a series A round. The round was led by Kleiner Perkins, with participation from GV, formerly Google Ventures. “One of the things we’re going to use the money is to expand beyond stroke and provide value to our hospitals, partners, and customers,” Chris Mansi, co-founder and CEO of Viz.ai., told MD+DI. “The second thing we’re going to use the money for is to ensure that more hospitals get access to our software.” Worldwide, mo...
Source: MDDI - July 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health 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

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

HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said. Data from the 465-patient supplemental cohort trial will be used to support pre-market approval for the HeartWare HVAD as a destination therapy system intended for long term use, according to the Framingham, Mass.-based company. The device is currently FDA approved for bridge-to-transplant applications....
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Surgical HeartWare International Inc. Source Type: news

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