FDAnews Device Daily Bulletin

FDA Grants De Novo Clearance for Merit Medical’s Embosphere

June 26, 2017

The Embosphere device won clearance from the FDA to be used in treatments for benign prostatic hyperplasia, specifically prostatic artery embolization procedures.

Merit Medical’s Embosphere device is the first embolic agent to be granted this level of clearance from the FDA for prostatic artery embolization treatment. This device allows a non-surgical treatment option for the condition.

Benign prostatic hyperplasia is a condition that affects men, and this device will improve the symptoms.

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