SonaCare Medical (Charlotte, NC) landed FDA de novo clearance for its Sonablate high intensity focused ultrasound (HIFU) system to be used for ablation of prostate tissue. Having de novo clearance means this is the first ultrasound device on the U.S. market to be indicated for removal of prostate tissue without invasive surgery.
The probe of the Sonablate is inserted via the rectum and it features two internal ultrasound transducers that are computer controlled. A treatment plan is set by the physician and the transducers move accordingly to deliver energy to the targeted tissue regions. By measuring the returning echo from the targeted region, the system is able to detect whether the tissue has been properly heated and functionally destroyed or if additional treatment is necessary.
The device can be used for total prostatectomies or partial prostate ablations.
While the system is only now receiving FDA clearance, it has been cleared in at least 50 countries and has been used extensively in large numbers of patients.
Product page: Sonablate…