PROCEPT BioRobotics’ Aquablation Meets Primary Endpoints in WATER II Study of 80 to 150 Milliliter Prostates

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

Today PROCEPT BioRobotics, a Silicon Valley robotics company developing intelligent surgical solutions to transform the field of urology, has announced early data from the global Phase III WATER II (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) Study showing the achievement of primary safety and efficacy endpoints for Aquablation in the treatment of benign prostatic hyperplasia (BPH). Presented yesterday at the American Urological Association (AUA) Annual Meeting in San Francisco by Co-principal Investigator, Mihir Desai, M.D., Professor of Clinical Urology and Director, Center for Advanced Robotics at the Keck School of Medicine of USC, the data demonstrated that use of Aquablation in men with prostate volumes ranging from 80 to 150 milliliters (mL) resulted in a significant improvement in both symptom scores and urinary flow rates, with a safety profile that met its predefined endpoint with statistical significance.

Aquablation, delivered by PROCEPT BioRobotics’ AquaBeam® System, uses a robotically controlled waterjet to remove prostate tissue without the application of heat. The single-arm, prospective WATER II Study of Aquablation enrolled 101 male patients, ages 45 to 80 years and with urinary symptoms due to BPH, at 16 sites in the United States and Canada. WATER II is a follow-up to the successful WATER Study, which showed a superior safety profile for Aquablation with very strong efficacy outcomes comparable to transurethral resection of the prostate (TURP) for the treatment of BPH in prostates size 30 to 80 mL.

“On the heels of the WATER Study, the results of the WATER II Study confirmed Aquablation delivers predictable and reproducible results regardless of the size of the prostate,” said Dr. Desai. “These results suggest that Aquablation can be a minimally invasive, transurethral option for patients with larger prostates who would otherwise only be candidates for simple prostatectomy.”

In addition to the WATER II results, Dr. Desai reported on a pooled analysis of 364 men with prostates ranging from 20 to 150 mL who were treated with Aquablation as part of five different clinical trials across six countries. The purpose of the analysis was to assess multiple hemostasis techniques, with and without heat, used following Aquablation and the implications on bleeding outcomes. In the analysis of all 364 patients, Aquablation had a very low rate of major bleeding events, with a peri-operative transfusion rate of less than three percent in prostates up to 150mL in volume. In addition, the analysis showed that the use of heat-free hemostasis techniques demonstrated no difference in overall bleeding events as compared to cautery after Aquablation.

“The pooled analysis demonstrated that, despite the increased prostate size in WATER II, hemostasis can be successfully achieved following Aquablation without the use of heat,” said Dr. Desai. “Given the range of prostate sizes treated and studied, the procedural consistency and overall safety profile of Aquablation is unlike any other single surgical technique for BPH.”

BPH is a highly prevalent condition affecting approximately 50 percent of men age 60 or older and 90 percent of men age 85 or older. About half of men diagnosed with BPH experience moderate-to-severe lower urinary tract symptoms (LUTS). Today, patients must decide to treat their BPH with surgical treatments such as TURP, which offer sustained symptom relief but a high risk of complications, or minimally invasive techniques that have a low risk of complications but are less effective for symptom relief. Aquablation offers the potential for symptomatic improvement similar to TURP with a superior safety profile and minimal learning curve for the surgeon.

“PROCEPT BioRobotics is committed to sound clinical research and we are excited to have the results of our second pivotal study presented as part of the AUA late-breaking abstracts for the second year in a row,” said Nikolai Aljuri, Ph.D., co-founder and chief executive officer of PROCEPT BioRobotics. “The results again confirm Aquablation can offer men a significant improvement in quality of life with a low risk of sexual side effects and the potential of becoming the treatment of choice for men suffering from BPH, independent of the size and shape of their prostate.”

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.