#USA #Boston #Butterfly Medical #BPH Device #Prostatic Retraction

Butterfly Medical Completes Pivotal Trial for BPH Treatment

Butterfly Medical, a pioneering company in medical devices, has announced the successful conclusion of its pivotal clinical trial for the Butterfly Prostatic Retraction Device, aimed at addressing benign prostatic hyperplasia (BPH). This innovative non-surgical solution promises to restore natural urine flow without the need for invasive procedures, which is a significant advancement in the treatment landscape for this common condition.

Clinical Study Highlights

The company conducted a comprehensive international study involving 244 patients to evaluate the safety and efficacy of their new device. The trial, which spanned 12 months, has confirmed that the Butterfly Prostatic Retraction Device is a viable first-line interventional therapy for men suffering from BPH. With 50% of men aged 51 to 60 experiencing urinary problems due to BPH and up to 90% of men over 80 affected, this new approach aims to alleviate the suffering of millions.

Butterfly Medical utilizes a minimally invasive technique that mechanically retracts the lateral lobes of the prostate, thereby improving urinary flow. Unlike traditional therapies, which may involve lifelong medication with various side effects or surgical alternatives that usually necessitate the removal of tissue, the Butterfly device offers a unique middle ground.

Expert Endorsements

Patrick MacCarthy, the CEO of Butterfly Medical, highlighted the significance of this trial, stating, "This trial marks a critical step in validating the Butterfly Prostatic Retraction Device as a safe and effective solution that avoids the limitations of early-generation BPH treatments." The study's outcomes align with favorable long-term follow-up data previously presented, showcasing the promises of durability in the Butterfly device as an effective long-term solution.

Acknowledging the clinical challenges men face in choosing their treatment options, Dr. James C. Ulchaker, Chief Medical Officer for Butterfly Medical, commented, "There is a significant gap in BPH care for men who are dissatisfied with medication but want to avoid the risks of invasive surgery." He noted that the Butterfly device conforms to the natural anatomy of the prostate, thereby providing relief without the need for cuts, burns, or tissue removal, which is a game-changer in the field.

Market Position and Future Prospects

Currently, the Butterfly device is CE Mark approved for use in the European Union, but it remains an investigational product in the U.S. The company is gearing up for an FDA pre-market approval (PMA) application, leveraging the success of this recent clinical trial. With the growing need for effective BPH treatments, Butterfly Medical is positioning itself strategically to tap into a market that has historically left many patients underserved.

Notably, the demand for innovative solutions such as the Butterfly Prostatic Retraction Device underscores a need for advancements in men’s health. Given the prevalence of BPH and the insufficiencies of traditional treatments, the Butterfly device represents a potential shift in how urologists will manage patient care moving forward.

Conclusion

The completion of this pivotal trial is a major achievement for Butterfly Medical, as it not only validates their innovative approach to treating BPH but also signifies a hope for many men struggling with this condition. As they await regulatory approvals, the company remains committed to reshaping BPH treatment and enhancing the quality of life for countless patients globally. By bridging the gap between medication and invasive surgery, Butterfly Medical aims to redefine standards of care in the urology market, reflecting their commitment to innovative healthcare solutions.

For further details and updates, visit Butterfly Medical’s website.