Medtronic Insertable Cardiac Monitor Detects Significantly Higher Rates of Atrial Fibrillation in Large and Small Vessel Stroke Patients Compared to Standard of Care

What Kind of Equipment is Used to Analyze DNA?

Below are some of a few basic processes followed throughout DNA testing. The general procedure entails:  • Isolating DNA from a sample containing the needed...

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced clinical trial results from the STROKE AF trial demonstrating the superiority of the Reveal LINQ™ Insertable Cardiac Monitor (ICM) to detect abnormal heartbeats, otherwise known as atrial fibrillation (AF), in both large and small vessel stroke patients compared to standard of care. The findings were published in the June 1, 2021 issue of the Journal of the American Medical Association (JAMA).

Stroke impacts more than 795,000 people every year. More than 87% of strokes are ischemic strokes, which occur when vessels that allow blood to flow to the brain are blocked. AF is a major risk factor for ischemic stroke. In fact, there is a five-fold increase in ischemic stroke risk for AF patients.

The STROKE AF study evaluated 496 patients, including 284 large vessel and 208 small vessel stroke patients. The findings demonstrated Reveal LINQ ICM was superior to the standard of care for AF detection:

  • At 12 months, AF was detected in 12.1% (or one in eight) patients in the ICM arm compared to 1.8% in the standard of care arm (HR=7.41; p<0.001). This equates to a greater than seven-fold increase in detecting AF in the ICM arm.
  • 78% of patients who had AF would have been missed if only monitored for 30 days.3
  • Median time to detection of AF was 99 days.
  • Rates of AF detection in the ICM arm were similar between patients with index strokes due to small vessel versus large vessel disease (12.6% compared to 11.7% respectively; p=0.74).
  • At 12 months, 96.3% of first AF episodes were asymptomatic in ICM arm.
  • The majority (55.5%) of patients with AF detected had an episode lasting more than one hour.

“STROKE AF showed that many patients with large vessel or small vessel stroke actually have AF, which is challenging to find using standard cardiac monitoring,” said Richard Bernstein, M.D., Ph.D., Northwestern Medicine Distinguished Physician in Vascular Neurology, Medical Director of Telehealth, and professor of Neurology, Northwestern University Feinberg School of Medicine. “Our job as neurologists includes identifying potential causes of future strokes to adequately protect our patients. AF is a risk that we can’t afford to miss, and without long-term monitoring, we are missing it.”

STROKE AF is a 1:1, randomized clinical trial, taking place at 33 clinical sites across the U.S. Individuals 60 years and older with ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days, as well as individuals 50 to 59 years older with stroke risk factors, were enrolled in the trial. Patients randomized to the ICM arm were given a Medtronic Reveal LINQ Insertable Cardiac Monitor. Patients in the control group received site-specific usual care, consisting of external cardiac monitoring such as 12-lead ECGs, Holter monitoring, telemetry, or event recorders. Incidence rates of AF and recurrent stroke will be compared over a three-year study duration. The study is led by co-principal investigators, Dr. Bernstein and Dr. Schwamm.

“Medtronic has been an innovative leader in ICM technology for 20 years and has made significant contributions to understanding the clinical utility of using ICMs in the cryptogenic stroke population, including publication of the CRYSTAL-AF Study in 2014. Now with the STROKE AF study, we are able to deepen our understanding in this additional patient population,” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic. “We believe that prolonged cardiac monitoring with the Reveal LINQ ICM can assist clinicians as they seek to prevent secondary strokes among their patients who have suffered an initial ischemic stroke. Findings from the STROKE AF study clearly validate the benefits of long-term monitoring for this high-risk population and have the potential to be practice-changing.”

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 of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles