Results Presented at AUA 2019 Support Use in a Broad Range of Patient Populations
REDWOOD SHORES, Calif. – May 20, 2019 – 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 prostates 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.About PROCEPT BioRobotics
Based in Silicon Valley, PROCEPT BioRobotics is a privately-held surgical robotics company enabling better patient care by developing transformative solutions in urology. The company offers the world’s first commercially available minimally invasive surgical robot providing autonomous tissue removal to safely and effectively treat BPH. Aquablation therapy, delivered by the AquaBeam Robotic System, combines the clarity of real-time, multi-dimensional imaging, autonomous robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) caused by BPH. For more information, visit http://www.PROCEPT-BioRobotics.com.
Prof. Thorsten Bach is a paid consultant of PROCEPT BioRobotics Corporation.
Important Safety Information: All surgical treatments have inherent and associated side effects. The most common side effects are mild and transient, and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include ejaculatory dysfunction and a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon. No claim is made that the AquaBeam Robotic System will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.