The device is the first HIFU device to receive FDA clearance for prostate tissue ablation. HIFU has been used around the world for prostate tissue ablation, but not in the US. With the FDA approval urological surgeons in the US will now also use this technology for their patients. HIFU provides precise delivery of ablative energy to the prostate, making it suitable for whole gland or focal gland ablation.

 

The Sonablate 450 device was developed by SonaCare Medical (Charlotte, NC, USA) and US distribution is expected to begin in October, 2015. The device is the second SonoCare medical device to receive FDA clearance – the first was the Sonatherm laparoscopic HITU ablation device which received 510(k) clearance. SonoCare Medical is now in the position to offer a full HIFU surgical suite.

 

Mark Carol, MD, CEO of SonaCare Medical, said, "The FDA regulatory authorization to market Sonablate in the US is a milestone for noninvasive prostate care and a tremendous gain for men's health. Men all over the world, in the more than 49 countries where it has already been authorized for use, have had access to this technology for prostate ablation. There are numerous peer reviewed articles attesting to its value in ablating the prostate while minimizing the occurrence of side effects. Our company is appreciative of the collaborative efforts made on the part of the FDA to bring this technology to the US In addition, this de novo clearance, together with the CE Mark for Sonablate500, will facilitate additional regulatory authorizations in markets beyond Europe and North America, further strengthening our world-wide market leadership in therapeutic HIFU devices."