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).
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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.
Furthermore, healthcare facilities can deploy the technology without purchasing specialised capital equipment.
The European certification follows the completion of a pivotal clinical study involving 244 patients.
In parallel with its European regulatory pathway, Butterfly Medical has submitted a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA).
Although the retraction device has obtained CE Mark certification under the EU MDR framework, federal regulators have not cleared the technology for commercial use in the US.
Butterfly Medical CEO Patrick MacCarthy said: “Securing EU MDR certification is a major milestone for Butterfly Medical. This achievement reflects years of clinical studies and quality system development, reinforcing our commitment to meeting rigorous regulatory standards.”
Butterfly Medical chief medical officer and Cleveland Clinic emeritus urologist Dr James Ulchaker said: “This certification represents an important step toward expanding treatment options for men living with BPH.
“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.”
As observed across therapeutic interventions for benign prostatic hyperplasia, the Butterfly procedure carries several recognised clinical risks.
Documented adverse events include bleeding, urinary discomfort, frequency, and urgency, whilst particular cases may require surgical removal of the prosthesis.
The manufacturer designed the minimally invasive device to relieve symptoms and improve patients’ quality of life, offering an alternative to both pharmaceutical therapies and invasive surgery.
In May 2026, Butterfly Medical raised $21m in Series C funding for the development and potential commercialisation of its minimally invasive device for BPH.
