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Abbott's (ABT) Amplatzer Amulet Occluder Trial Data Favorable

Abbott's (ABT) Amulet IDE trial findings supported the recent FDA approval of Abbott's Amplatzer Amulet LAA Occluder to reduce the risk of stroke in p...

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This story originally appeared on Zacks

Abbott Laboratories ABT recently presented late-breaking data from the Amulet LAA Occluder IDE trial comparing the company's Amplatzer Amulet Left Atrial Appendage (LAA) Occluder with Boston Scientific’s BSX Watchman device to treat people with atrial fibrillation (AFib) at a high risk of stroke. The study outcomes were presented in a late-breaking Hot Line session at ESC Congress 2021 organized by the European Society of Cardiology.

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The result demonstrated that Amulet Occluder was better in LAA closure and noninferior on safety and effectiveness endpoints as compared to the Watchman device.

The recent development for Abbott’s Amulet is expected to expand the company’s structural heart customer base within the Medical Device arm.

The trial findings supported the recent FDA approval of Abbott's Amplatzer Amulet LAA Occluder to reduce the risk of stroke in patients with atrial fibrillation.

More on Amulet LAA Occluder

Abbott's Amulet device is the first and only minimally-invasive option approved for LAA occlusion that does not need blood-thinning medication following implantation. The Amulet device with Dual-Seal technology offers immediate closure of the LAA, thereby reducing the risk of stroke.

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Amulet LAA Occluder also provides a broad range of sizes to help physicians treat a large range of patients and enables recapturing and repositioning to ensure optimal placement.

The Amulet initially received CE Mark in 2013, following which it has been approved for use in more than 80 countries.

Study Findings

Amulet device demonstrated advantages for people suffering from atrial fibrillation, who are at risk of stroke and in need of LAA occlusion. Amulet IDE trial data showed that patients can be treated effectively with Amulet without the use of blood thinners following implant.

The study findings showed that Abbott's Amulet Occluder with Dual-Seal technology was implanted successfully in 98.4% of patients compared to 96.4% of patients receiving the Watchman device. The device also established superiority for the primary endpoint of LAA closure compared to the Watchman device.

The results also showed that only 20% of Amulet patients were discharged on anticoagulant therapy (warfarin plus aspirin) compared with 82% of Watchman patients.

Significance of the Study Outcome

Per Abbott’s management, the Amulet device has the potential to transform the way physicians approach LAA occlusion therapy, backed by the strength of Amulet IDE data and the potential to immediately close the LAA.  By offering immediate, better LAA closure, the Amulet device will enable Americans living with atrial fibrillation to experience peace of mind against the worry of having a stroke without the need for blood-thinning medication immediately following the procedure.

Industry Prospects

Per a report published in Persistence Market Research, the global atrial fibrillation devices market is expected to see a CAGR of 14% during 2020-2030. Factors such as growing incidence of Afib amongst the geriatric and adult population, rising adoption of minimally-invasive techniques as a treatment for Afib, technological advancements and a favorable reimbursement scenario are expected to fuel market growth during the forecast period.

Recent Developments

In August 2021, Abbott released favorable data from its GUIDE-HF clinical trial on its small implantable pulmonary pressure sensor, CardioMEMS HF System. Adjusting for the impact of COVID-19, the study data shows that in a broad range of patients, there has been a strong decline in the composite endpoint of heart failure hospitalizations, emergency visits and death.

In the same month, Abbott received FDA authorization for its latest optical coherence tomography (OCT) imaging platform, powered by the company's new Ultreon Software. The Ultreon Software is the first-of-its-kind imaging software that combines OCT with artificial intelligence to offer physicians an enhanced and comprehensive view of coronary blood flow and blockages to assist in physicians’ decision-making and provide the best treatment course for patients.

Price Performance

Shares of the company have gained 18.2% in a year’s time compared with the industry’s rise of 10.9%.

Zacks Rank and Key Picks

Currently, Abbott carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST and BellRing Brands, Inc. BRBR, both carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 27%.

BellRing Brands has an estimated long-term earnings growth rate of 29%.



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