Butterfly Medical Receives CE Approval for its Next Generation Medical Device to Noninvasively Treat BPH Patients

Butterfly Medical, today announced that its next generation device to reduce or eliminate benign prostatic hyperplasia (BPH) symptoms has obtained European CE Mark approval.

BPH is a condition where the prostate enlarges and is highly prevalent in men, 50+ years old. Its symptoms often include problems urinating, urgency to urinate, getting-up during the night, as well as sexual dysfunction all having a significant negative impact on quality of life. Medication is often the first line of therapy, but relief can be inadequate and temporary, with patients needing invasive surgical procedures.

Butterfly’s next generational device provides a much-needed simple, fast and minimally invasive treatment option, by focusing on the truly obstructive aspects of BPH. Its unique anatomically shaped proprietary nitinol implant is positioned in the prostatic urethra in order to open the urine path in the prostate for improved urine flow thereby relieving BPH symptoms. The device comes in multiple sizes, and, unlike more invasive approaches, does not require any resection, cutting, or ablation of prostatic tissue.

The procedure can be completed with local anaesthesia in under ten minutes in the urologist’s office, with patients being able to get back to normal activities immediately. It is also completely reversible, with the device easily removed, ensuring patients can benefit from any future therapy, if necessary.

Results from clinical trials are very promising with blocked urethras successfully opened having an immediate and long term effect on patients’ quality of life.