FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Contego Medical Cleared for Angioplasty System

Dec. 10, 2018
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The FDA has granted 510(k) clearance for Contego Medical’s Vanguard IEP, a peripheral balloon angioplasty system designed to keep patients at high risk of embolization safe during angioplasties.

The device is designed to protect patients that are vulnerable to embolization — the passage and lodging of an object, such as a blood clot, in the blood stream — during peripheral angioplasties, in which a surgeon repairs or unblocks blood vessels.

The system, which has an over-the-wire design, is able to protect the patient’s lower limbs during angioplasty and requires no additional devices or exchanges.

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