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The robotic expertise used for the Aquablation process. | Supply: Procept BioRobotics
Procept BioRobotics Corp. final week introduced that the U.S. Meals and Drug Administration has permitted an Investigational Gadget Exemption, or IDE, trial of its Aquablation remedy.
The San Jose, Calif.-based firm additionally lately acquired Breakthrough Gadget Designation to research the usage of Aquablation remedy for prostate most cancers. The FDA awards such designations in distinctive instances, expediting the evaluation of novel therapies that may enhance the lives of individuals with life-threatening or irreversibly debilitating ailments or circumstances.
The expertise may “change the way in which urologists deal with localized prostate most cancers for tens of millions of males,” said Dr. Inderbir Gill, founding government director of USC Urology, a part of the Keck Faculty of Medication on the College of Southern California.
Procept BioRobotics develops personalised therapy
Aquablation makes use of ultrasound-guided, robot-assisted, heat-free waterjet to resection and exactly eradicate prostate tissue. The system gives the surgeon with a multi-dimensional view of the affected person’s prostate.
This strategy remedy permits personalised therapy planning tailor-made to every affected person’s distinctive anatomy, claimed Procept BioRobotics. It permits the surgeon to specify which areas of the prostate to take away whereas preserving the anatomy that controls erectile perform, ejaculatory perform, and continence.
Aquablation guarantees to be an efficient most cancers therapy whereas sustaining the affected person’s high quality of life, mentioned Procept BioRobotics. (The corporate was featured on MassDevice‘s checklist of the highest urology system tales up to now in 2024.)
Procept BioRobotics initially acquired FDA IDE for its Aquablation process in September 2023. The corporate’s next-generation Hydros surgical robotic — cleared by the FDA in August — delivers Aquablation remedy.
Aquablation trial to observe sufferers for 10 years
The WATER IV PCa trial will evaluate Aquablation to radical prostatectomy. It’s going to deal with hurt discount through the use of Aquablation as a first-line therapy as compared with radical prostatectomy, mentioned Procept BioRobotics.
The corporate added that it expects the research to enroll as much as 280 males with Grade Group 1 to three localized prostate most cancers. It’s going to happen throughout 50 facilities, following the sufferers for 10 years.
The trial has a co-primary endpoint primarily based on morbidity evaluated on the six-month follow-up. Longer-term follow-up will deal with each the discount in treatment-related hurt and oncologic occasions, Procept mentioned.
“A big alternative exists to enhance security and high quality of life outcomes for males needing therapy for prostate most cancers,” mentioned Reza Zadno, CEO of Procept BioRobotics. “We consider Aquablation remedy has the flexibility to turn out to be a first-line therapy for localized prostate most cancers. Initiating a randomized trial in opposition to radical prostatectomy is the primary massive step in pursuing a prostate cancer-specific indication, which no different energy-based therapy has as we speak,”
“It’s thrilling to see that the FDA permitted an IDE after a immediate and thorough evaluation of the trial design, and we stay up for seeing the outcomes of the forthcoming trial and are hopeful concerning the prospects of this novel expertise,” mentioned Gill. He’s additionally chairman of the Catherine & Joseph Aresty Division of Urology at Keck.
Editor’s observe: This text was syndicated from The Robotic Report sibling web site MassDevice.
