Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
The strategic acquisitions expand the company’s structural heart disease technologies.
The deal will help strengthen the Edwards portfolio of smart monitoring technologies.
The companies are finally putting to bed all outstanding patent disputes.
The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.
The Class I recall is a result of a mold overflow defect that could obstruct blood flow.
This year the company exceeded its expectations, too.
The Inspiris Resilia valve is intended for aortic valve replacement.
The approval gives high-risk patients a less-invasive treatment option.