Butterfly Medical secures EU MDR certification for BPH implant

The European certification follows the conclusion of a pivotal clinical study evaluating 244 patients.

Israel-based Butterfly Medical has secured European Union Medical Device Regulation (EU MDR 2017/745) certification for its Butterfly Prostatic Retraction Device.

The anatomically contoured implant addresses urinary symptoms caused by benign prostatic hyperplasia (BPH).

Positioned as an intermediate option between drug regimens and conventional surgical operations, the retraction system aims to facilitate urine flow without ablating, excising, or burning prostate tissue.

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