Cardiovascular Catch-Up: Abbott, Medtronic, Boston Scientific Stay Hot During Summer
Executive Summary
June, July and August brought a number of important new approvals and trial announcements from the major cardiac device companies. Here are some of the highlights you might have missed during the summer.
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Women May Face Additional Risks From LAAO Treatment, FDA Cautions
The US agency issued a letter to providers in the wake of a study that found significantly higher complication rates in women implanted with Boston Scientific’s Watchman device.
Abbott Becomes Third US TAVR Competitor With Portico Approval
Portico with the FlexNav delivery system earned FDA approval for people with symptomatic, severe aortic stenosis who would be at high or extreme risk in open-heart surgery.
Amulet IDE Trial Supports Abbott’s New LAA Closure Device
Results of the trial showed Amplatzer Amulet was superior to Boston Scientific’s Watchman for left-atrial appendage closure and noninferior for safety and effectiveness.