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)
Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

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 (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
New Simplera Sync sensor for the MiniMed 780G System now FDA approved

New Simplera Sync sensor for the MiniMed 780G System now FDA approved

Latest approval expands Medtronic CGM portfolio in the U.S.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

FN Media Group News Commentary - Artificial intelligence (AI) is being utilized for disease detection in the global markets. In today's AI-driven world, the use of deep learning algorithms and AI tools in diagnostics can improve the accuracy, speed and efficiency for diagnosing patients with minimal errors. The introduction of AI tools in diagnostics has revolutionized the healthcare industry with supporting the doctors in advanced disease diagnosis and providing personalized treatments to patients with better judgements and quick results. According to Precedence Research, the global artificial intelligence in diagnostics market size was exhibited at USD 1.61 billion in 2024 and is projected to hit around USD 8.54 billion by 2033, growing at a CAGR of 20.37% during the forecast period 2024 to 2033. The report said: "The advances in digital biomarkers technology which uses real-time monitoring systems for early disease diagnosis and prediction has also enhanced the AI in diagnostics market growth. The application of AI tools in diagnostics has led to analyzing medical images for assessing disease progression, predicting patient outcomes, processing and storing of patient data which includes electronic health records (EHRs), identifying patterns and anomalies in patient data and symptom checkers for providing potential diagnosis."   Active healthcaretech companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Illumina Inc. (NASDAQ: ILMN), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Spectral AI, Inc. (NASDAQ: MDAI).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology .

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×