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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 accepted an Investigational Machine Exemption, or IDE, trial of its Aquablation remedy.
The San Jose, Calif.-based firm additionally not too long ago obtained Breakthrough Machine Designation to research using Aquablation remedy for prostate most cancers. The FDA awards such designations in distinctive circumstances, expediting the evaluation of novel therapies that may enhance the lives of individuals with life-threatening or irreversibly debilitating ailments or situations.
The expertise might “change the way in which urologists deal with localized prostate most cancers for hundreds of thousands of males,” said Dr. Inderbir Gill, founding government 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 gives the surgeon with a multi-dimensional view of the affected person’s prostate.
This strategy remedy permits 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, mentioned Procept BioRobotics. (The corporate was featured on MassDevice‘s listing of the highest urology gadget 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 observe sufferers for 10 years
The WATER IV PCa trial will evaluate Aquablation to radical prostatectomy. It is going to deal with hurt discount through the use of Aquablation as a first-line remedy 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 is 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 major alternative exists to enhance security and high quality of life outcomes for males needing remedy for prostate most cancers,” mentioned Reza Zadno, CEO of Procept BioRobotics. “We imagine Aquablation remedy has the power to turn into a first-line remedy 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 remedy has in the present day,”
“It’s thrilling to see that the FDA accepted an IDE after a immediate and thorough evaluation of the trial design, and we look ahead to seeing the outcomes of the forthcoming trial and are hopeful in regards to the prospects of this novel expertise,” mentioned 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.
