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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 accepted an Investigational Machine Exemption, or IDE, trial of its Aquablation remedy.
The San Jose, Calif.-based firm additionally not too long ago acquired Breakthrough Machine Designation to research using Aquablation remedy for prostate most cancers. The FDA awards such designations in distinctive circumstances, expediting the assessment of novel therapies that may enhance the lives of individuals with life-threatening or irreversibly debilitating ailments or circumstances.
The know-how may “change the best way urologists deal with localized prostate most cancers for hundreds of thousands of males,” acknowledged 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 therapy
Aquablation makes use of ultrasound-guided, robot-assisted, heat-free waterjet to resection and exactly eradicate prostate tissue. The system offers the surgeon with a multi-dimensional view of the affected person’s prostate.
This method 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 operate, ejaculatory operate, and continence.
Aquablation guarantees to be an efficient most cancers therapy 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 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 comply with sufferers for 10 years
The WATER IV PCa trial will examine Aquablation to radical prostatectomy. It’ll concentrate on hurt discount by utilizing Aquablation as a first-line therapy compared with radical prostatectomy, stated 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’ll 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 concentrate on each the discount in treatment-related hurt and oncologic occasions, Procept stated.
“A big alternative exists to enhance security and high quality of life outcomes for males needing therapy for prostate most cancers,” stated Reza Zadno, CEO of Procept BioRobotics. “We imagine Aquablation remedy has the flexibility to turn into 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 at this time,”
“It’s thrilling to see that the FDA accepted an IDE after a immediate and thorough assessment of the trial design, and we look ahead to seeing the outcomes of the forthcoming trial and are hopeful concerning the prospects 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.