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

First-of-its-kind Aurora EV-ICD™ system offers single device, single procedure with lead placed outside of heart and veins

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.

FDA approval of the Medtronic Aurora EV-ICD system includes the system's proprietary procedure implant tools, and was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine . In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States .

"The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology," said Bradley P. Knight , M.D., medical director of Electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and a co-author of the study. "Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology."

In the pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%, and there we no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system compared to transvenous and subcutaneous ICDs.[1] Additionally, 33 defibrillation shocks were avoided 1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed "on." And at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death. 1

ICDs are highly effective in providing life-saving therapy for patients at risk of SCA, an electrical problem with the heart due to a dangerously fast heart rate (ventricular tachycardia) or irregular rhythm (ventricular fibrillation). If not treated immediately, SCA is often fatal (termed sudden cardiac death). Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart.

"This FDA approval paves the way for patients to have a better overall experience with ICD therapy," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "ICDs remain the gold standard for prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient's comfort and quality-of-life. With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and back-up pacing, in a device that is nearly half the size and with 60% greater projected battery longevity compared to the competitor's subcutaneous ICD."

The Aurora EV-ICD system is similar in size, shape, and longevity to traditional, transvenous ICDs. Unlike traditional ICDs, the Aurora EV-ICD system is implanted below the left armpit (in the left mid-axillary region) and the lead is placed under the breastbone (sternum) using a minimally invasive approach. The Epsila EV defibrillation lead is placed outside of the heart and veins, helping to avoid certain complications associated with transvenous leads, such as vascular injury and vessel occlusion (narrowing, blockage or compression of a vein).

The Aurora EV-ICD system includes features available in Medtronic transvenous ICDs, and offers additional advantages that are not available with the subcutaneous ICD including:

  • Anti-tachycardia Pacing (ATP), to terminate ventricular arrhythmias (rapid and/or chaotic activity of the heart that can lead to SCA) using low-energy pacing pulses, potentially avoiding a defibrillation shock.
  • Pause Prevention Pacing, to provide back-up pacing for brief, intermittent, heartbeat pauses.
  • 40 Joule Defibrillation Energy, to deliver life-saving shocks in a device the size of transvenous ICDs (33 cc)
  • Medtronic exclusive PhysioCurve™ design, to increase patient comfort and implant acceptance.
  • 11.7-year projected longevity, to reduce device replacement procedures during a patient's lifetime.

Patients who receive the commercially available Aurora device also will benefit from the addition of Smart Sense, a proprietary algorithm designed to reduce the potential for inappropriate shocks.

Medtronic will obtain real-world performance and safety data on the Aurora system in the Enlighten global post-approval registry, a prospective, non-randomized, observational, multicenter study, expected to last five years and enroll approximately 1,000 patients. First implants in Enlighten and first commercial implants worldwide were recently conducted by Lucas V.A. Boersma , M.D., Ph.D., cardiologist at St. Antonius Hospital, Nieuwegein, The Netherlands , and a limited launch is underway in select European countries.

The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, and who have not had a prior sternotomy and do not need chronic bradycardia (abnormally slow heartbeat) pacing.

About the EV ICD Pivotal Study

The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. It enrolled 356 patients at 46 sites in 17 countries in North America , Europe , the Middle East , Asia , Australia and New Zealand , and results were published in The New England Journal of Medicine . Safety and effectiveness results were sustained out to 18 months. 2

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

-end-

Contacts:


Tracy McNulty

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-2492

+1-763-505-4626

______________________________________________

1 Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med 2022; 387:1292-1302.
2 Friedman P, Murgatroyd F, Boersma LVA, et al. Chronic Safety and Performance of the Extravascular ICD: Results from the Global EV ICD Pivotal Study. Heart Rhythm Society late breaking clinical trials, May 20, 2023 .

Medtronic Aurora EV-ICD™ system

Medtronic Aurora EV-ICD™ system

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-receives-fda-approval-for-extravascular-defibrillator-to-treat-abnormal-heart-rhythms-sudden-cardiac-arrest-301963889.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

MDT
The Conversation (0)
Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. (TSX: PNE) ("Pine Cliff" or the "Company") announces its first quarter 2024 financial and operating results, an operational update and information regarding the annual meeting of shareholders.

First Quarter 2024 Results

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Canadian Natural Resources Limited Announces 2024 First Quarter Results

Canadian Natural's (TSX: CNQ) (NYSE: CNQ) President, Scott Stauth, commented on the Company's first quarter results, "Canadian Natural is a world class company and during our 35 years of operations, we've delivered significant value, including recently reaching a position where, commencing in 2024, we are returning 100% of our free cash flow to our shareholders. Crude oil price forecasts have strengthened for the remainder of 2024, including improvements in West Texas Intermediate ("WTI"), Western Canadian Select ("WCS") and Synthetic Crude Oil ("SCO") pricing over those prices experienced in the first quarter of 2024, driving significant targeted free cash flow generation going forward.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. (TSX: PNE) (OTCQX: PIFYF) ("Pine Cliff" or the "Company") is pleased to announce the appointments of Mr. Daniel Keenan P. Eng to the position of Vice President Exploitation and Mr. Austin Nieuwdorp CA, CPA to the position of Vice President Finance and Controller both effective May 1, 2024.

Mr. Keenan became part of Pine Cliff in 2016. He holds a Bachelor of Mechanical Engineering Degree from the University of Victoria obtained in 2001. Throughout his 20-year career, he has taken on increasingly challenging roles in exploitation, production operations and facilities engineering, culminating in his most recent position as Pine Cliff's Manager of Exploitation. Notably, Mr. Keenan has played a pivotal role in identifying and expanding Pine Cliff's asset portfolio and drilling opportunities, showcasing his leadership and strategic vision.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. (TSX: ACO.X) (TSX: ACO.Y)

2024 ATCO AGM (CNW Group/ATCO Ltd.)

ATCO Ltd. (ATCO) will hold its 57th Annual General Meeting of share owners at 10 a.m. MDT on Wednesday , May 15, 2024. In addition to the formal business of the meeting, attendees will hear management's view of ATCO's full year 2023 and first quarter 2024 operational and financial performance.

At this year's meeting, members of the ATCO executive leadership team will also outline growth strategies and goals for ATCO Structures, ATCO EnPower and ATCO Energy Systems.

Attendees will hear from:

  • Nancy Southern , Chair & Chief Executive Officer
  • Katie Patrick , Executive Vice President, Chief Financial & Investment Officer
  • Adam Beattie , President, ATCO Structures
  • Bob Myles , Chief Operating Officer, ATCO EnPower
  • Wayne Stensby , Chief Operating Officer, ATCO Energy Systems

Share owners and interested parties can view the meeting virtually using Microsoft Teams via this link using a web browser (Chrome, Safari, Edge or Firefox) on a smartphone, tablet or computer. Using Internet Explorer is not recommended as it is no longer supported and may not function properly.

Attendees who are share owners or proxyholders wishing to vote their shares should review the information contained in the ATCO Management Proxy Circular dated March 11, 2024 , beginning on page one.

As a global enterprise ATCO Ltd. and its subsidiary and affiliate companies have approximately 20,000 employees and assets of $25 billion . ATCO is committed to future prosperity by working to meet the world's essential energy, housing, security and transportation challenges. ATCO Structures designs, builds and delivers products to service the essential need for housing and shelter around the globe. ATCO Frontec provides operational support services to government, defence and commercial clients. ATCO Energy Systems delivers essential energy for an evolving world through its electricity and natural gas transmission and distribution, and international operations. ATCO EnPower creates sustainable energy solutions in the areas of renewables, energy storage, industrial water and clean fuels. ATCO Australia develops, builds, owns and operates energy and infrastructure assets. ATCOenergy and Rümi provide retail electricity and natural gas services, home maintenance services and professional home advice that bring exceptional comfort, peace of mind and freedom to homeowners and customers. ATCO also has investments in ports and transportation logistics, the processing and marketing of fly ash, retail food services and commercial real estate. More information can be found at www.ATCO.com .

Investor & Analyst Inquiries:  
Colin Jackson
Senior Vice President, Finance, Treasury & Sustainability
Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
Kurt Kadatz
Director, Corporate Communications
Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/29/c6613.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces First Quarter 2024 Results, Record Oil Royalty Production

-

PrairieSky Royalty Ltd. ("PrairieSky" or the "Company") (TSX: PSK) is pleased to announce its first quarter ("Q1 2024") operating and financial results for the three-month period ended March 31, 2024.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health Responds to Rumors of a Potential Sale of Bausch + Lomb

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, issued the following statement in response to a request from the Canadian Investment Regulatory Organization (CIRO

"As previously disclosed, the Company believes that completing the full separation of its subsidiary, Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), makes strategic sense. The Bausch Health Board of Directors authorized management and management of its subsidiary, Bausch + Lomb, to explore a potential sale, which is one of several options being considered to complete the separation. That process is ongoing. No decision has been reached to proceed with any particular transaction, and there can be no assurance that it will result in a transaction.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Medtronic announces cash dividend for third quarter of fiscal year 2025

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, December 5, 2024, approved the company's cash dividend for the third quarter of fiscal year 2025 of $0 .70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on January 10, 2025 to shareholders of record at the close of business on December 27, 2024 .

About Medtronic
Bold thinking. Bolder actions. We are Medtronic . Medtronic plc , headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic , visit www.Medtronic.com and follow Medtronic on LinkedIn .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited (ASX:CDX)

Cardiex Limited


Keep reading...Show less

Bausch Health and Salix in Collaboration with Health Organizations Recognize the Second Annual Opioid-Induced Constipation Awareness Day

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), alongside the U.S. Pain Foundation (USPF), the International Foundation for Gastrointestinal Disorders (IFFGD), and the American Chronic Pain Association (ACPA) have united to recognize today, Thursday, December 5, as the second annual Opioid-Induced Constipation (OIC) Awareness Day. This important day is dedicated to bringing awareness to a commonly-overlooked side effect of opioids. By raising awareness and fostering open conversations, OIC Awareness Day seeks to reduce the stigma surrounding this condition and offer support to the many patients impacted by OIC

"As an organization dedicated to supporting individuals living with pain conditions, we're proud to participate in this year's OIC Awareness Day," said Kathy Sapp, CEO of ACPA. "By increasing awareness and improving communication between healthcare providers, patients, and caregivers, we can make a meaningful difference for those affected by this commonly occurring condition."

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Global Medical Service Robotics Market Project to Exceed $20 Billion in 2024 with Additional Growth Expected

FN Media Group News Commentary - Innovations in robotics technology, including artificial intelligence machine learning, and sensor technology, are enhancing the capabilities of medical robots. These advancements enable more precise surgical procedures, improved rehabilitation processes, and efficient hospital logistics, thus attracting more healthcare facilities to adopt robotic solutions. The market is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to expand the business to cater to the growing demand for medical service robots. A report from Grand View Research said that the global medical service robots market size was estimated at USD 20.59 billion in 2024 and is projected to grow at a CAGR of 16.5% from 2025 to 2030. It said: "The growth can be attributed to the introduction of technologically advanced robotic equipment in the healthcare sector and the rise in per capita healthcare spending. Continuous advancements in technology, such as robotic catheter control systems (CCS), data recorders, data analytics, remote navigation, motion sensors, 3D-Imaging, and HD surgical microscopic cameras, are projected to drive industry growth. Furthermore, the introduction of swarm robotics is opening new opportunities for industry. It is a new approach to coordinating multi-robotic systems through swarm intelligence." Active Tech Companies in the markets today include Jeffs' Brands Ltd (NASDAQ: JFBR), Serve Robotics Inc. (NASDAQ: SERV), Symbotic Inc. (NASDAQ: SYM), Microbot Medical Inc. (NASDAQ: MBOT), Medtronic plc (NYSE: MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×