Over 450 Total Lots Up For Auction at Three Locations - CO 05/12, PA 05/15, NY 05/20

FDA Grants De Novo request for PROCEPT BioRobotics AQUABEAM System

Press releases may be edited for formatting or style | December 22, 2017

“The AQUABEAM System allows surgeons to determine an optimal tissue removal plan for each individual patient and achieve predictable, reproducible results, even in the case of larger prostates and prostates with obstructive median lobes,” said Co-Principal Investigator Peter Gilling, MD, professor of surgery at the University of Auckland, Bay of Plenty Clinical School Tauranga. “Additionally, the easy-to-use system coupled with autonomous robotic resection paves the way to the future of surgery by enabling consistent results, independent of surgeon experience.”

The AQUABEAM System is commercially available in Canada, Australia, New Zealand and select European markets. In the U.S., the device will be commercially available in early 2018.

stats Advertisement
DOTmed text ad

Training and education based on your needs

Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money

stats

“FDA granted the De Novo request just two years after treating the first patient in our U.S. pivotal trial. This is a remarkable achievement, and I congratulate our talented and dedicated team of employees, physicians and researchers, and everyone who worked tirelessly to make this significant milestone for our organization possible,” said Nikolai Aljuri, Ph.D., PROCEPT BioRobotics chief executive officer and principal architect of the AQUABEAM System and its core Aquablation technology. “We believe Aquablation therapy is poised to fundamentally transform the way physicians treat men suffering from BPH.”

About Benign Prostatic Hyperplasia (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.[1] In the United States, there are over 12 million men being actively managed for their condition, of which two million have failed medical management and are looking for alternative treatment options. Today’s treatment options range from surgical treatments such as TURP and lasers that remove the excess prostate tissue using extreme heat, to minimally invasive clips that simply push the prostate tissue to the side. Unfortunately, the treatments that offer the most significant symptom relief also have the highest complication rates, forcing the patient to choose between the two.

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. With an initial focus on benign prostatic hyperplasia (BPH), the company’s first product, the AQUABEAM System delivering Aquablation therapy, is the world’s first commercially available minimally invasive surgical robot providing autonomous tissue removal to safely and effectively treat BPH. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy or surgeon experience. http://www.procept-biorobotics.com

1. http://emedicine.medscape.com/article/437359-overview#a2

Back to HCB News

You Must Be Logged In To Post A Comment