Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval
The US FDA approved Boston Scientific's Lotus Edge transcatheter aortic valve for patients who would be at high risk with surgical valve replacement. Unlike competing TAVR systems from Medtronic and Edwards, Lotus Edge can be repositioned or recaptured after it has been deployed.
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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.
The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate neo2 transcatheter aortic valve system. The decision will cost the company up to $300m.
Abbott enters the highly competitive TAVR market with its newly CE-marked FlexNav delivery system for Portico.