"Response has been very gratifying and quite overwhelming since the FDA authorized selling of the device for the ablation of prostate tissue ... " - Dr. Mark Carol
Charlotte, NC (PRWEB) November 11, 2015
SonaCare Medical, LLC announces that the first prostate tissue ablation procedure performed in the United States was completed yesterday using its Sonablate® High Intensity Focused Ultrasound (HIFU) technology.
This inaugural procedure was performed seamlessly by Dr. John H. Jurige and his team at First Urology Kentucky. Dr. Jurige has held a long-standing relationship with SonaCare Medical, having performed more than 400 HIFU procedures over the past eight years outside the United States through SonaCare Medical’s subsidiary company, International HIFU, for which he has served as a proctor and medical director. He has been a strong advocate for having this technology accessible to American men in-country. "Men deserve to be offered minimally invasive options close to home. Sonablate® HIFU, in the face of intensive scrutiny, has been proven over the long term to provide proper eradication of targeted prostate tissue while preserving vital quality of life functions. We are excited and proud to be the first to use this groundbreaking technology in the U.S."
First Urology is one of twelve facilities that have acquired Sonablate® technology since SonaCare Medical received de novo authorization to market the device in the U.S. less than four weeks ago. SonaCare Medical’s CEO, Dr. Mark Carol, remarks that "Response has been very gratifying and quite overwhelming since the FDA authorized selling of the device for the ablation of prostate tissue. American physicians have been waiting a long time to be able to deploy this technology in their own practices. We are thrilled that the first commercial use of focused ultrasound technology for prostate ablation in the U.S. was achieved with Sonablate®, and delighted that it was used by one of our most experienced and supportive Sonablate® surgeons, Dr. John Jurige."
Since the introduction of Sonablate® technology over 15 years ago, it has been used around the world to treat nearly 15,000 patients in over 30 countries at 130 installations.
About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.
For additional information, visit http://www.SonaCareMedical.com
SonaCare Medical, LLC
Erica Griffith (704) 936-1834, EricaGriffith(at)SonaCareMedical(dot)com
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