Sam Brusco, Associate Editor09.12.23
PROCEPT BioRobotics, a surgical robotics company, has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate safety and efficacy of its Aquablation therapy for prostate cancer.
Aquablation therapy is an image-guided, automated, heat-free robotic therapy to treat benign prostatic hyperplasia (BPH). The system’s real-time ultrasound imaging offers a multi-dimensional view of the prostate, so personalized treatment planning can be tailored to unique anatomy. The surgeon can then determine which prostate areas to remove while retaining the anatomy that controls erectile function, ejaculatory function, and continence.
Once the treatment plan is created, the automated robot removes prostate tissue using heat-free waterjet technology.
The IDE nod lets PROCEPT BioRobotics begin a single-arm feasibility study in the U.S. The company said data gathered from this study will support future research and regulatory applications in the U.S. The study will enroll patients with localized prostate cancer at three cancer centers: Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center.
“Aquablation Therapy, recognized for its efficacy and safety in resecting prostate tissue for BPH, offers a potential paradigm shift in how urologists might address localized prostate cancer. The waterjet resection technique has the distinct capability to precisely eradicate prostate tissue, providing the potential of an effective cancer treatment while maintaining the patient's quality of life,” Dr. Inderbir Gill, founding executive director for USC Urology, part of Keck Medicine of USC, told the press.
Reza Zadno, CEO of PROCEPT BioRobotics, added, "Receiving IDE approval to explore Aquablation Therapy for men with localized prostate cancer marks a pivotal moment for PROCEPT. While our primary commitment is to establish ourselves as the standard of care for the treatment of BPH, we acknowledge the distinctive potential of our robotic system to address other urological indications." Zadno added, "Our aim is to bolster the clinical evidence through this study and collaborate with some of the nation's foremost cancer physicians.”
Aquablation therapy is an image-guided, automated, heat-free robotic therapy to treat benign prostatic hyperplasia (BPH). The system’s real-time ultrasound imaging offers a multi-dimensional view of the prostate, so personalized treatment planning can be tailored to unique anatomy. The surgeon can then determine which prostate areas to remove while retaining the anatomy that controls erectile function, ejaculatory function, and continence.
Once the treatment plan is created, the automated robot removes prostate tissue using heat-free waterjet technology.
The IDE nod lets PROCEPT BioRobotics begin a single-arm feasibility study in the U.S. The company said data gathered from this study will support future research and regulatory applications in the U.S. The study will enroll patients with localized prostate cancer at three cancer centers: Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center.
“Aquablation Therapy, recognized for its efficacy and safety in resecting prostate tissue for BPH, offers a potential paradigm shift in how urologists might address localized prostate cancer. The waterjet resection technique has the distinct capability to precisely eradicate prostate tissue, providing the potential of an effective cancer treatment while maintaining the patient's quality of life,” Dr. Inderbir Gill, founding executive director for USC Urology, part of Keck Medicine of USC, told the press.
Reza Zadno, CEO of PROCEPT BioRobotics, added, "Receiving IDE approval to explore Aquablation Therapy for men with localized prostate cancer marks a pivotal moment for PROCEPT. While our primary commitment is to establish ourselves as the standard of care for the treatment of BPH, we acknowledge the distinctive potential of our robotic system to address other urological indications." Zadno added, "Our aim is to bolster the clinical evidence through this study and collaborate with some of the nation's foremost cancer physicians.”