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The robotic know-how used for the Aquablation process. | Supply: Procept BioRobotics
Procept BioRobotics Corp. final week introduced that the U.S. Meals and Drug Administration has authorized an Investigational System Exemption, or IDE, trial of its Aquablation remedy.
The San Jose, Calif.-based firm additionally not too long ago obtained Breakthrough System Designation to research the usage of Aquablation remedy for prostate most cancers. The FDA awards such designations in distinctive instances, expediting the assessment of novel therapies that may enhance the lives of individuals with life-threatening or irreversibly debilitating illnesses or circumstances.
The know-how might “change the way in which urologists deal with localized prostate most cancers for thousands and thousands of males,” said Dr. Inderbir Gill, founding govt director of USC Urology, a part of the Keck Faculty of Drugs on the College of Southern California.
Procept BioRobotics develops personalised remedy
Aquablation makes use of ultrasound-guided, robot-assisted, heat-free waterjet to resection and exactly eradicate prostate tissue. The system supplies the surgeon with a multi-dimensional view of the affected person’s prostate.
This method remedy allows personalised remedy 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 remedy whereas sustaining the affected person’s high quality of life, stated Procept BioRobotics. (The corporate was featured on MassDevice‘s record of the highest urology machine tales to date in 2024.)
Procept BioRobotics initially obtained 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 comply with sufferers for 10 years
The WATER IV PCa trial will evaluate Aquablation to radical prostatectomy. It should concentrate on hurt discount by utilizing Aquablation as a first-line remedy compared with radical prostatectomy, stated Procept BioRobotics.
The corporate added that it expects the examine to enroll as much as 280 males with Grade Group 1 to three localized prostate most cancers. It should happen throughout 50 facilities, following the sufferers for 10 years.
The trial has a co-primary endpoint based mostly on morbidity evaluated on the six-month follow-up. Longer-term follow-up will concentrate on each the discount in treatment-related hurt and oncologic occasions, Procept stated.
“A major alternative exists to enhance security and high quality of life outcomes for males needing remedy for prostate most cancers,” stated Reza Zadno, CEO of Procept BioRobotics. “We consider Aquablation remedy has the power to develop into a first-line remedy for localized prostate most cancers. Initiating a randomized trial towards radical prostatectomy is the primary large step in pursuing a prostate cancer-specific indication, which no different energy-based remedy has right this moment,”
“It’s thrilling to see that the FDA authorized an IDE after a immediate and thorough assessment of the trial design, and we stay up for seeing the outcomes of the forthcoming trial and are hopeful concerning the potentialities of this novel know-how,” stated Gill. He’s additionally chairman of the Catherine & Joseph Aresty Division of Urology at Keck.
Editor’s word: This text was syndicated from The Robotic Report sibling website MassDevice.
