Late-Breaking Data Shows Abbott's Amplatzer Amulet Occluder Offers Superior Left Atrial Appendage Closure Compared to Watchman? Device for People With Atrial Fibrillation at Risk of Stroke

Abbott (NYSE: ABT) today announced late-breaking data from the Amulet™ LAA Occluder IDE trial, a multi-center, head-to-head study comparing the company's Amplatzer™ Amulet Left Atrial Appendage (LAA) Occluder with the Watchman‡ device (Boston Scientific) to treat patients with atrial fibrillation (AFib) at an increased risk of stroke. The results of the trial show Abbott's Amulet device was superior for the primary endpoint of LAA closure and noninferior for the primary endpoints of safety and effectiveness versus the comparator device.

The findings were presented today in a late-breaking Hot Line session at ESC Congress 2021 organized by the European Society of Cardiology and simultaneously published in Circulation . The trial results supported the recent U.S. approval of Amulet .

The LAA is a small pouch connected to the upper left chamber of the heart. For people with AFib, the heart's ability to effectively pump blood can be disrupted, allowing blood to pool and collect in the LAA causing an increased risk for clotting. If clots reach the blood stream, they can travel to the brain and cause a stroke. Abbott's Amulet device with Dual-Seal technology (a lobe to fill the body of the LAA and a disc to close off the opening into the LAA) offers immediate closure of the LAA, reducing the risk of stroke and – unlike the study comparator device – immediately eliminates the need for blood-thinning medication following implant. Amulet Occluder also offers a wider range of sizes to help physicians treat a broad range of patients and allows recapturing and repositioning to ensure optimal placement.

"Atrial fibrillation cases have increased in recent years as the world continues to age, making stroke risk more prevalent and resulting in higher usage of blood-thinning medication that can lead to bleeding and other complications," said Dhanunjaya Lakkireddy , M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health, who served as principal investigator for the study. "Amulet demonstrated a clear benefit for people suffering from atrial fibrillation who are at risk of stroke and in need of LAA occlusion. The Amulet IDE trial data show that we can effectively treat these patients with Amulet and get them off blood thinners immediately following implantation."

A Strong Foundation of Clinical Evidence
The Amulet IDE trial is the first multicenter, large-scale randomized study to compare Abbott's Amulet device head-to-head with the Watchman device.

Results from the study demonstrated that Abbott's Amulet Occluder with Dual-Seal technology:

  • Was successfully implanted in 98.4% of patients compared to 96.4% of patients receiving the Watchman device.
  • Demonstrated superiority for the primary endpoint of LAA closure compared to Watchman (98.9% vs. 96.8%, p (superiority) = 0.0025).
  • Was noninferior to the comparator device for the co-primary safety endpoint (a composite of procedure-related complications, all-cause death or major bleeding through 12 months) and co-primary effectiveness endpoint (a composite of ischaemic stroke or systemic embolism through 18 months).

Importantly for patients and their physicians, Amulet did not require the use of blood thinners for participants following implant in the study. Watchman patients were mostly (82%) discharged on anticoagulant therapy (warfarin plus aspirin). In contrast, only 20% of Amulet patients were discharged on anticoagulants, and most (75.7%) were discharged on dual antiplatelet therapy (clopidogrel plus aspirin).

"Now backed by the strength of the Amulet IDE data and the ability to immediately close the LAA, our Amulet device has the potential to change the way physicians approach LAA occlusion therapy," said Michael Dale , senior vice president of Abbott's structural heart business. "Offering immediate, superior LAA closure allows Americans living with atrial fibrillation to experience greater peace of mind against the worry of having a stroke without the need for blood-thinning medication immediately following the procedure."

The Amplatzer Amulet LAA Occluder has been approved for use in more than 80 countries, including in Europe , Canada and Australia , since its initial CE Mark approval in 2013. Amulet is part of the Abbott Amplatzer family of products with proven clinical success for more than two decades.

For U.S. important safety information on Amulet, visit: https://abbo.tt/AmuletISI .

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
© 2021 Abbott. All Rights Reserved.

Cision View original content: https://www.prnewswire.com/news-releases/late-breaking-data-shows-abbotts-amplatzer-amulet-occluder-offers-superior-left-atrial-appendage-closure-compared-to-watchman-device-for-people-with-atrial-fibrillation-at-risk-of-stroke-301364970.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

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

×