Conductance quantum

Viz.ai and Medtronic Collaborate to Improve Post-Acute Stroke Patient Care in the United States

Retrieved on: 
Tuesday, March 26, 2024

Viz.ai, Inc., the leader in AI-powered disease detection and intelligent care coordination, today announced a strategic collaboration with Medtronic to improve the coordination of cryptogenic stroke patient care between the neurology and cardiology teams.

Key Points: 
  • Viz.ai, Inc., the leader in AI-powered disease detection and intelligent care coordination, today announced a strategic collaboration with Medtronic to improve the coordination of cryptogenic stroke patient care between the neurology and cardiology teams.
  • For stroke patients who are at risk of atrial fibrillation (“AF”) post-stroke and may need additional cardiac monitoring, stroke care teams in the U.S. will have the opportunity to use the Viz Connect™ solution, a software tool that automates the communication across disciplines, including neurology and cardiology.
  • Recent clinical study results indicate that both community hospitals and academic centers are in need of stronger, standardized care pathways between neurology and cardiology to ensure that stroke patients receive guideline-directed therapy.
  • According to the DiVERT Stroke clinical study, only 16% of stroke patients from community hospitals and 34% of patients at academic centers received a cardiology consult.1
    “Through our collaboration with Medtronic, we have the opportunity to bring cardiology and neurology closer together by using software tools that help facilitate stroke patient care,” said Chris Mansi, MD, CEO and co-founder at Viz.ai.

Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest

Retrieved on: 
Monday, October 23, 2023

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs.

Key Points: 
  • In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States.
  • [1] Additionally, 33 defibrillation shocks were avoided1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed "on."
  • Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart.
  • Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Nieuwegein, The Netherlands, and a limited launch is underway in select European countries.

Medtronic Extravascular ICD global clinical trial results reinforce device safety and effectiveness

Retrieved on: 
Saturday, May 20, 2023

DUBLIN and NEW ORLEANS, May 20, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced longer-term follow-up results of its investigational EV ICD™ System, designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study, including patients followed through an average of 17.1 months, were presented as late-breaking science at Heart Rhythm 2023 in New Orleans. The EV ICD system is investigational and not yet approved for sale or distribution in the United States.

Key Points: 
  • The system offers anti-tachycardia pacing (ATP), pause prevention pacing, and a device similar in size, shape, and battery longevity to transvenous ICDs.
  • Using a minimally invasive approach, the device is implanted below the left armpit (in the left mid-axillary region).
  • "The EV ICD system is the first to include all of this functionality in a single extravascular device."
  • First-time ICD recipients (225,444 patients, of which 179,638 were primary prevention) implanted with a Medtronic Evera™ or Visia™ single- or dual-chamber ICD were included.

Medtronic receives FDA approval for its next generation Micra leadless pacing systems

Retrieved on: 
Monday, May 1, 2023

DUBLIN, May 1, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniaturized, leadless pacemakers.

Key Points: 
  • DUBLIN, May 1, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniaturized, leadless pacemakers.
  • Comparable in size to a multivitamin, Micra pacemakers are less than one-tenth the size of traditional pacemakers.
  • Leaders in Cardiac Pacing This FDA approval builds on the Medtronic legacy in cardiac pacing, which includes:
    Inventing the first wearable pacemaker in 1957.
  • Gaining regulatory approval for the first pacing system to activate the heart's natural electrical system, conduction system pacing (approval via the His-bundle in 2018 and via the left bundle branch area in 2022).

Medtronic Receives CE Mark for Extravascular Defibrillator System That Treats Abnormal Heart Rhythms

Retrieved on: 
Friday, February 17, 2023

DUBLIN, Feb. 17, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT) has received CE (Conformité Européenne) Mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The Aurora EV-ICD system provides the life-saving benefits of traditional ICDs while avoiding certain risks because its lead (thin wire) is placed outside the heart and veins. The Aurora EV-ICD system is investigational in the United States.

Key Points: 
  • The Aurora EV-ICD system provides the life-saving benefits of traditional ICDs while avoiding certain risks because its lead (thin wire) is placed outside the heart and veins.
  • The Aurora EV-ICD system is expected to be commercially available in autumn 2023 in select countries in Europe.
  • There were no major intraprocedural complications, nor any unique complications observed related to the EV-ICD procedure or system.
  • "This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience."