Watchman, watch out: Abbott challenges Boston

The latest in Abbott’s Amplatzer suite of heart defect repair devices has just gained US approval, and the company will be gunning for a market currently cornered by Boston Scientific. The Amplatzer Amulet is a catheter-mounted device designed to close off the left atrial appendage (LAA) in atrial fibrillation patients. The LAA is a small sac in the atrial wall; AF patients cannot pump blood out of their atria effectively, and there is a risk that blood can pool in the appendage, forming clots that can cause strokes. The leading product here is Boston’s Watchman, forecast to do $1.4bn of business in 2026, according to Evaluate Medtech. Watchman, which has been on the market since 2015, has just escaped potential competition from Atricure’s Lariat device after that product’s clinical trial failed. Exactly how well Amulet stacks up will become clear in a couple of weeks: full data from its head-to-head trial versus Watchman will appear on August 30 at the European Society of Cardiology meeting. This study was the basis for Amulet’s approval, so Abbott’s device clearly demonstrated non-inferiority at a minimum. But superiority might be necessary to persuade doctors to switch from the established product.

Abbott's Amplatzer devices
Device Indication Pathway US approval date Review time (yr)
Amplatzer Amulet left atrial appendage occluder Closure of LAA in patients with atrial fibrillation at risk of ischaemic stroke Premarket approval Aug 2021 0.6
Amplatzer post-infarct muscular VSD occluder Closure of post-myocardial infarction VSD Humanitarian device exemption Jan 2017 9.6
Amplatzer PFO occluder* Closure of patent foramen ovale (PFO) in patients who have had a cryptogenic stroke  Premarket approval Oct 2016 3.9
Amplatzer muscular VSD occluder Closure of congenital ventricular septal defect (VSD) in high-risk surgical patients Premarket approval Sep 2007 2.9
Amplatzer duct occluder** Closure of patent ductus arteriosus Premarket approval May 2003 0.9
Amplatzer septal occluder Closure of atrial septal defects or surgical openings Premarket approval Dec 2001 1.3
*Initially granted HDE in April 2002. **Duct occluder II and Amplatzer Piccolo also approved under supplements. Source: Evaluate Medtech & company release. 

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