Butterfly Prostatic Retraction Device granted EU MDR certification for BPH

Butterfly Medical has received European Union Medical Device Regulation (EU MDR) certification for its Butterfly Prostatic Retraction Device to relieve lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).¹

The company said the implant is intended to provide an alternative for men seeking symptom relief without long-term medication or tissue-removing procedures. The announcement follows completion of a 244-patient pivotal clinical trial and submission of a premarket approval (PMA) application to the FDA, according to the company.

Related: Pivotal trial of Butterfly Medical device for BPH reaches final completion

"This certification represents an important step toward expanding treatment options for men living with BPH," said James C. Ulchaker, MD, Chief Medical Officer for Butterfly Medical and Emeritus Urologist at the Cleveland Clinic, in the news release.¹ "BPH affects men differently, and patients deserve treatment options that address their individual needs and preferences, including the desire to avoid tissue ablation or long-term medication."

Device design

The Butterfly Prostatic Retraction Device is an anatomically designed implant intended to improve urinary flow by retracting prostatic tissue to relieve obstruction. The device is designed to address the mechanical component of bladder outlet obstruction without cutting or burning tissue. The company also states that the procedure does not require dedicated capital equipment.

Butterfly Medical identified potential procedure-related risks that include urinary discomfort, urgency, frequency, bleeding, and possible device removal.

About the pivotal study

Butterfly Medical announced successful completion of its pivotal randomized controlled trial (NCT05341661) of the Butterfly Prostatic Retraction Device in January 2026.²

In total, the prospective, double-blind study enrolled 244 men aged 50 years or older with BPH across clinical trial sites in the US.³ To be eligible for enrollment, patients needed to have a prostate length of 25 mm to 45 mm, a prostate volume of 30 mL to 90 mL, and symptomatic BPH, defined as an International Prostate Symptom Score (IPSS) of 13 or higher and a score of 1 or higher on the IPSS voiding-subscore ratio.

Patients enrolled in the study were randomly assigned 2:1 to receive the Butterfly device or undergo a sham rigid cystoscopy procedure. Crossover was permitted in the trial. The dual primary end points were the change in IPSS from baseline to 3 months and from baseline to 12 months.

Results from the study were also intended to support the premarket appproval application submitted to the FDA.

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REFERENCES

1. Butterfly Medical achieves EU MDR certification for next-generation BPH treatment. News release. Butterfly Medical. October 13, 2026. Accessed October 13, 2026. https://www.prnewswire.com/news-releases/butterfly-medical-achieves-eu-mdr-certification-for-next-generation-bph-treatment-302906797.html

2. Butterfly Medical announces completion of pivotal trial for minimally invasive treatment of benign prostatic hyperplasia. News release. Butterfly Medical. January 8, 2026. Accessed October 13, 2026. https://www.prnewswire.com/news-releases/butterfly-medical-announces-completion-of-pivotal-trial-for-minimally-invasive-treatment-of-benign-prostatic-hyperplasia-302656312.html

3. Butterfly pivotal study. ClinicalTrials.gov. Last updated May 29, 2026. Accessed October 13, 2026. https://clinicaltrials.gov/study/NCT05341661