Medtronic Evaluates Insertable Cardiac Monitor in Identifying Patients at High Risk of Worsening Heart Failure

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced first enrollments in the ALLEVIATE-HF clinical trial which will evaluate the ability of its Reveal LINQ™ Insertable Cardiac Monitor (ICM) in identifying patients at high-risk of worsening heart failure. The trial will determine if early information provided by the LINQ devices enable clinicians to take action before patients' conditions worsen. The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health.

The Reveal LINQ ICM allows physicians to continuously and wirelessly monitor a patient's heart for arrhythmia disorders. With a proprietary algorithm added to the Reveal LINQ system for this study, clinicians will be alerted to signs of worsening heart failure. They will receive the information via nightly transmissions delivered to the Medtronic CareLink® Network from patients' bedside monitors. Patient data will be stratified by risk level, providing physicians remote access to patient data and allowing them to intervene earlier than possible without this system.

The first patients were enrolled at Cardiology Associates of North Mississippi by Dr. Barry Bertolet , and Florida Heart Center by Dr. Prasad Chalasani . The trial is a prospective, randomized, multisite, interventional, investigational device exemption (IDE) study that will enroll up to 300 patients at up to 30 sites across the United States . Patients will be followed a minimum of seven months and up to three years. With the commencement of the ALLEVIATE-HF trial, Medtronic is the first to study the use of an ICM to manage heart failure in a remote setting.

Heart failure affects approximately 6.2 million Americans and causes or contributes to an estimated 380,000 deaths per year in the United States alone. 1 The condition occurs when the heart isn't pumping enough blood to meet the body's needs. As a result, fluid may build up in the legs, lungs, and in other tissues throughout the body, leaving patients feeling tired or experiencing shortness of breath. Therapeutic options for those with heart failure may include medication, cardiac resynchronization therapy (CRT) or an implantable cardioverter-defibrillator (ICD).

"It's vital that clinicians know about the early warning signs of worsening heart failure, and this study will help us determine if the new LINQ algorithm will identify that information so we can take action," said Javed Butler , M.D., chairman of the Department of Medicine at the University of Mississippi , and chair of ALLEVIATE-HF Steering Committee. "Remote monitoring may transform treatment and personalize the ongoing management of patients, and we look forward to having more evidence to help physicians proactively manage their patients, even without a face-to-face visit."

The Reveal LINQ ICM is approximately one-third the size of a AAA battery (~1 cc) and is placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest, using a minimally invasive procedure. The device communicates wirelessly with a patient bedside monitor that uploads device data to the CareLink Network; it is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. The remote monitoring feature of the LINQ device could potentially reduce unnecessary in-office visits since physicians have remote access to patient data. Medtronic introduced the world's first remote cardiac monitoring system in 2002, and it has been implanted in 1.3 million patients worldwide ever since.

"For two decades, Medtronic has been an innovator in cardiac monitoring, allowing for diagnosis and management in the home rather than the hospital environment," said Rob Kowal , M.D., Ph.D., chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "Heart failure management is a critical element in extending the capabilities of the LINQ platform beyond arrhythmia management to reach more patients with the right interventions before heart failure progresses. By initiating the ALLEVIATE-HF trial, Medtronic endeavors to help improve how clinicians receive actionable insights to better treat higher-risk patient populations."

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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.

1 Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW , Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Associationexternal icon . Circulation. 2020;141(9):e139-596.

Contacts:




Lauren Mueller

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-285-9053

+1-763-505-4626

Medtronic plc (PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-evaluates-insertable-cardiac-monitor-in-identifying-patients-at-high-risk-of-worsening-heart-failure-301136165.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Limited (ASX: HMD), a medical data and technology company leading the digital transformation of maternity care, is delighted to announce it has entered into a collaboration agreement with Garmin (NYSE: GRMN), a leading global provider of smartwatches and GPS-enabled products, aimed at enhancing remote pregnancy monitoring and expanding the range of health data available to expectant mothers and their healthcare providers.

Keep reading...Show less
Cardiologist wearing virtual reality glasses.

2 Biggest Medical Device ETFs in 2025

Exchange-traded funds (ETFs) are a popular investment strategy, and generally contain a variety of publicly traded companies under one stock symbol, often with a focus on a specific sector.

Depending on the ETF, investors may be able to track up-and-coming companies, get exposure to top firms or a mix of both. Aside from stocks, some ETFs also track commodities or bonds.

In the healthcare industry, medical device ETFs bring together companies that go to great lengths to develop pharmaceutical-based technology that can improve the lives of patients.

Keep reading...Show less
Cyclomedica

Cyclopharm Signs US Agreement with HCA Healthcare for Technegas®

Cyclopharm Limited (ASX: CYC) is pleased to announce the signing of a major contract with Hospital Corporation of America Healthcare (HCA), one of the largest single healthcare providers in the United States. This agreement marks a significant milestone for the company which will allow the deployment of Technegas® in up to 169 nuclear medicine departments across HCA’s extensive network.1

Keep reading...Show less
CONNEQT App Launches in USA as Pulse Deliveries Commence

CONNEQT App Launches in USA as Pulse Deliveries Commence

Cardiex Limited (CDX:AU) has announced CONNEQT App Launches in USA as Pulse Deliveries Commence

Download the PDF here.

Female doctor with clipboard talking to smiling female patient at hospital.

Revolutionizing Women's Health: Antifungal Innovation Brings New Investment Opportunities

The intersection of women's health and antifungal innovation represents a pivotal moment in healthcare, offering both transformative medical advancements and compelling investment opportunities.

The groundbreaking developments in antifungal treatments specifically targeting women's health issues present a substantial market potential, resulting in rising investor interest in this rapidly evolving sector.

Despite comprising half the global population, women face unique health challenges that have historically received insufficient attention and investment. Among these health challenges, vaginal candidiasis stands out as a persistent and widespread issue affecting millions of women worldwide.

Keep reading...Show less

Latest Press Releases

Related News

×