Charlotte, NC (PRWEB) October 28, 2014
SonaCare Medical, manufacturer of High Intensity Focused Ultrasound (HIFU) ablative devices, announces ongoing progress at Stony Brook University in Stony Brook, NY where Dr. David Schulsinger and his team are conducting the first North American Institutional Review Board (IRB) approved treat and resect study of kidney cancer in humans with SonaCare's Sonatherm® laparoscopic soft tissue HIFU Surgical Ablation Device.
This study, under leadership of Dr. David Schulsinger, MD, Associate Professor of Urology and Director of Endourology, Laparoscopy, Stone Disease & Ablative Therapies, is designed to evaluate the technical aspects of Sonatherm® HIFU ablation for primary renal cancer in patients who are undergoing a clinically mandated partial nephrectomy. Under the study protocol, Dr. Schulsinger performed the first Sonatherm® human kidney procedure in the United States at Stony Brook in May of 2014. Dr. Schulsinger has an extensive background in urologic research, lecturing and training fellow urologists both nationally and internationally. He has contributed over 30 book chapters, 45 publications in peer reviewed journal articles and a book on his urologic clinical work. He completed his fellowship training at New York Presbyterian Hospital and the Mayo Clinic in Rochester, MN.
According to Dr. Schulsinger, “This novel technology represents an advancement in renal ablation given its unique ability to simultaneously image, ablate and track results all with the same laparoscopic probe. Potential advantages to patients include nephron sparing, minimal blood loss, low complications and quick recovery.”
Mark Carol, MD, CEO of SonaCare Medical comments, “Pioneering physicians like Dr. Schulsinger are instrumental in advancing new technology and procedures. The feedback we are gaining from David and his team (including Dr. Waltzer, Dr. Darras, Dr. Sheynkin, Dr. Felix Cheung and Scott Herfel) is of utmost importance to SonaCare’s research and development efforts. We look forward to continuing to work closely with Dr. Schulsinger and the entire team at Stony Brook University.”
The initial study protocol commenced in May with three patients having been treated out of a total of 18 scheduled to be enrolled in their study, the most recent being October 27th.
Sonatherm® uses a unique robotic laparoscopic ultrasound probe and sophisticated software to image, and plan a treatment. Additionally, the probe delivers precise focused ultrasound energy directly into targeted soft tissue areas, which can be accessed through standard laparoscopic ports allowing for minimally invasive procedures. The probe runs on the SonaCare Medical Sonasource® bi-modal surgical HIFU console.
About SonaCare Medical
SonaCare Medical, a privately held, venture-backed healthcare company, is a world leader in minimally-invasive high intensity focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing technologies for urological indications that offer precise and innovative procedures that can control cancer and reduce potential quality of life altering side effects. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures high intensity focused ultrasound (HIFU) medical devices, including the following: Sonablate® 450 which is investigational in the U.S. and being studied in a pivotal FDA clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with external beam radiation therapy; Sonablate® 500, which has CE Marking and is, or has been, approved for use to treat prostate cancer in more than 30 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S. Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and is not indicated for the ablation of prostate tissue. The FDA has made no decision as to the safety or efficacy of Sonablate® 450 or 500. In the event Sonablate® 450 is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same for treatment approved or authorized in other countries outside of the U.S. SonaCare Medical was founded in 2004 and is headquartered in Charlotte, N.C.
For additional information, visit http://www.SonaCareMedical.com.