CHARLOTTE, N.C., April 11, 2017 /PRNewswire/ -- SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces the launch of an International Sonablate HIFU Registry. The High Intensity Focused Ultrasound Evaluation and Assessment of Treatment (HEAT) Registry will be a globally accessible, web-based, platform for storing HIFU data on patients treated with Sonablate.
Registries are used commonly to provide an organized system for collecting clinical data on a cohort of patients with comparable conditions. The HEAT Registry will collect large volumes of procedural and outcomes data for Sonablate® prostate tissue ablations and will be solely overseen by academic professionals. This provides a reliable source of longitudinal data about the efficacy of HIFU and its developing importance in the realm of minimally-invasive ablative prostate care.
"Having an organized and consolidated source of clinical data has been a barrier for HIFU technology to reach its full potential," comments Dr. Mark Carol, CEO of SonaCare Medical. "Knowing the enormous benefits HIFU prostate tissue ablation has already provided to thousands of men, SonaCare Medical is eager and excited to see this registry come together. It will allow researchers to accelerate the development of a HIFU knowledge base collected from around the world on a single platform, speeding the ability to assess outcomes which will help drive improvements in the technology. Ultimately, we want patients to feel confident about making an informed treatment decision."
The easy-to-use HEAT registry provides intuitive means for users to enter, analyze, and audit their own personal databases as well as to collaborate internationally with colleagues on cross practice experience. The registry is a web-based, browser-operated, electronic database running on the REDCap software system. REDCap was developed in the U.S. as a joint effort on the parts of Vanderbilt University, The National Center for Research Resources, and The National Institutes of Health, and is designed to comply with HIPAA regulations. The HEAT registry already has enrolled more than 1,500 international patients. U.S. Patient enrollment began this month.
"SonaCare Medical looks forward to supporting this international registry and witnessing the global advancement, accessibility to, and appreciation of HIFU's application in prostate treatment around the world," adds Dr. Carol.
Since Sonablate® received FDA clearance on October 09, 2015, there have been over 40 acquisitions of Sonablate® technology, including placements at top-tier U.S. academic institutions located in California, Indiana, Maryland, New York, Arizona, and Texas. Over 43 U.S. physicians now offer HIFU prostate tissue ablation to their patients as a minimally-invasive alternative to surgery or radiation.
About SonaCare Medical, LLC
SonaCare Medical is a world leader in minimally invasive focused ultrasound 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.; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 50 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.
To arrange an interview about SonaCare Medical's affiliation with The International HIFU Registry, please contact us at info@SonaCareMedical.com.
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SOURCE SonaCare Medical