PROCEPT BioRobotics® Announces New Clinical And Real-World Data Highlighting Effectiveness, Durability, Superior Safety And Reproducibility Of Aquablation® Therapy For BPH

New clinical data presented at the American Urological Association (AUA) Annual Meeting confirmed that PROCEPT BioRobotics’ Aquablation therapy is a durable, safe, effective and reproducible minimally invasive surgical treatment option for benign prostatic hyperplasia (BPH). Longer-term data from controlled FDA pivotal studies demonstrated durability of Aquablation therapy in a broad range of prostate sizes, while real-world experience from Germany in non-selected patients confirmed reproducibility and yielded results consistent with the pivotal studies. With no restriction on prostate size, Aquablation therapy with the AQUABEAM^® Robotic System is the only FDA-cleared autonomous robot for surgery.

“These longer-term study results, and the recent addition of Aquablation therapy to the AUA surgical practice guidelines for BPH, position Aquablation therapy as a new standard of care for patients suffering from BPH,” said Nikolai Aljuri, Ph.D., PROCEPT BioRobotics president and chief executive officer. “Aquablation therapy is the only BPH treatment that democratizes BPH surgery by delivering predictable and reproducible outcomes from day one, independent of prostate anatomy, size or complexity – and it does so regardless of surgeon experience.”

• Naeem Bhojani, M.D., associate professor at the Université de Montréal, Montréal, Canada, presented one-year data from the WATER II Study (Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue) evaluating Aquablation therapy in 101 men with large prostates 80 to 150 milliliters (mL) in size. Results demonstrated that Aquablation therapy is a safe surgical alternative for patients with large prostate glands, with durable outcomes at one year, coupled with fast operative times, short hospitalizations, and the maintenance of antegrade ejaculatory function. The Aquablation procedure proved to be an effective and reproducible treatment for BPH up to 150 mL.
• Peter Gilling, M.D., co-principal investigator and professor of surgery at the University of Auckland, Bay of Plenty Clinical School, Tauranga, New Zealand, presented two-year follow-up data from the WATER Study, which compared the safety and efficacy of Aquablation therapy to transurethral resection of the prostate (TURP). The study results demonstrated longer term, durable evidence of the safety and effectiveness of Aquablation therapy for lower urinary tract symptoms (LUTS) due to BPH in men with prostates between 30 and 80 mL in size. In the 181 patient cohort, Aquablation therapy demonstrated similar durable outcomes at two years compared to TURP with a low retreatment rate; equivalent urodynamic obstruction relief at six months with consistent uroflow improvement from six months through two years; and symptom score improvement comparable to other resective techniques.
• Prof. Thorsten Bach, chief physician in urology at Asklepios Hospital Harburg in Hamburg, Germany, highlighted single-center results of a consecutive, 180-patient cohort treated with Aquablation therapy between September 2017 and June 2018. Results demonstrated safety and efficacy measures consistent with the WATER and WATER II outcomes in a real-life setting in a non-selected patient cohort. “The presented results of this largest single-center cohort are emphasizing the future potential of this new treatment modality for benign prostatic obstruction (BPO),” the award-winning poster stated.

– Business Wire