Butterfly Medical Announces EU MDR Certification for BPH Implant

Butterfly Medical announced certification under the European Union’s Medical Device Regulation, MDR 2017/745, for its Butterfly Prostatic Retraction Device, an implant intended to relieve urinary symptoms associated with benign prostatic hyperplasia. In its release issued from Boston and Yokneam, Israel, the company said the milestone follows a 244-patient pivotal clinical trial and submission of a Premarket Approval application to the U.S. Food and Drug Administration. The implant is designed to improve urinary flow without cutting, burning or removing prostate tissue. The device has not received FDA approval for commercial use in the United States.