The HIFU Evaluation and Assessment of Treatment (HEAT) Registry Now Includes Data from Over 100 U.S. Sonablate® Patients
CHARLOTTE, N.C., April 5, 2018 /PRNewswire/ -- SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces the enrollment of over 100 patients from the United States into the High Intensity Focused Ultrasound Evaluation and Assessment of Treatment (HEAT) Registry.
The HEAT Registry collects large volumes of procedural and outcomes data for Sonablate® prostate tissue ablations 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.
"The collection of this U.S. patient data is critical to the continued development, improvement, and acceptance of HIFU. The United States medical device market can be a difficult sector to navigate beyond the initial obstacle of receiving FDA regulatory authorization. We need to prove the efficacy of this technology to American clinicians and patients using U.S. clinical data," comments Dr. Mark Carol, CEO of SonaCare Medical. "We are thrilled to see the HEAT registry reach such a significant milestone, and believe that this foundation of U.S. patient data will continue to show the enormous benefits HIFU has to offer prostate patients from a quality of life perspective. We are additionally grateful to all of our HIFU physicians in the U.S. and around the globe who have participated in registering their clinical data in one or more registries and who continue to be advocates for patient-centered care."
The easy-to-use HEAT registry provides an intuitive platform for users to enter, analyze, and audit their own personal databases as well as to collaborate with blinded data from colleagues worldwide. 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 has already enrolled more than 2,000 patients from across the world.
Several HEAT Registry participants will be attending the Prostate Imaging and Focal Therapy Masterclass at Imperial College London beginning tomorrow, April 6th. Under the direction of Professor Hashim Ahmed, more than 120 urologists, using or interested in using HIFU, will learn various state-of-the-art techniques for diagnosing and treating focal/localized prostate cancer. More than 90 of these attendees will participate in a hands-on Sonablate simulator training.
To arrange an interview about SonaCare Medical's affiliation with the HEAT Registry, please contact us at [email protected].
Since Sonablate® received FDA clearance on October 09, 2015, more than 1,500 patients have had a Sonablate HIFU prostate procedure across the 40+ locations in the U.S., including top-tier academic institutions in California, Indiana, Oklahoma, Maryland, New York, Arizona, and Texas. Over 70 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.
For additional information, visit www.SonaCareMedical.com
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SOURCE SonaCare Medical, LLC
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