SonaCare Medical HIFU Device Used in Fifth U.S. Facility.
Charlotte, NC (PRWEB) December 15, 2015 -- SonaCare Medical, LLC, the leading manufacturer of urologic HIFU technology and the first to receive FDA regulatory authorization for the ablation of prostate tissue, has announced the fifth location in the United States to perform a Sonablate® procedure post FDA clearance. The miVIP Surgery Center, in Tustin, California, installed Sonablate® in mid-November and its leading physician, Dr. Ashok Kar, performed the center’s first U.S.-based prostate tissue ablation procedure this past weekend on December 12th.
Dr. Ashok Kar has been actively using Sonablate® technology since 2012 and is an avid supporter of high intensity focused ultrasound for the ablation of targeted tissue in the prostate. Like many other physicians who used the technology prior to its clearance for use in the U.S., Dr. Kar regularly brought patients to facilities outside of the United States so that they could benefit from the advantages of this non-invasive prostate procedure. Dr. Kar’s decision to deploy Sonablate® at miVIP is a testament to the value he has seen this technology bring to the field of urologic care over the years. Dr. Kar remarks, "As an experienced Robotic surgeon, I am excited to offer HIFU as an alternative to surgery or radiation to selected patients. HIFU has been used globally for the past 14 years and is now available to us in the U.S. I have treated many patients overseas using HIFU and am impressed with the outcomes of retaining continence and sexual function. With the use of Duplex Doppler during the treatment, we are able to protect the neurovascular bundles that are necessary for sexual function. In the near future, with the fusion of MRI and ultrasound technologies, focal treatment of the "significant" lesion will be available. I am pleased that we are the first ambulatory surgery center in Southern California to offer this technology."
Dr. Mark Carol, CEO of SonaCare Medical is delighted with the continued success of Sonablate® in the United States and increased presence on the West Coast, commenting, “Dr. Kar has been a long standing supporter of HIFU for the ablation of prostate tissue. We are thrilled that he now has this capability within his own facility and look forward to supporting him as he looks to make this technology accessible to other practicing urologists.”
Sonablate® was the first device to receive regulatory authorization from the FDA for the focused ultrasound ablation of prostate tissue. Since its introduction over 15 years ago, Sonablate® technology has been used around the world on nearly 15,000 patients in over 30 countries, including approximately 4,000 U.S. men who have had this procedure performed outside the U.S.
About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive high intensity 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
COMPANY CONTACT:
SonaCare Medical, LLC
Erica Griffith (704) 936-1834, EricaGriffith(at)SonaCareMedical(dot)com
Forward Looking Statements.
The Company's forward-looking statements are based on management's current expectations and assumptions regarding the Company's business and performance, the economy and other future conditions and forecasts of future events, circumstances and results. As with any projection or forecast, forward-looking statements are inherently susceptible to uncertainty and changes in circumstances. The Company's actual results may vary materially from those expressed or implied in its forward-looking statements. Any forward-looking statement made by the Company speaks only as of the date on which it is made. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, subsequent events or other factors.
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Erica Griffith, SonaCare Medical, http://www.sonacaremedical.com, +1 7049361834, [email protected]
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