FORT MILL, SC / ACCESSWIRE / May 9, 2023 / Ra Medical Systems announced that its subsidiary, Catheter Precision, has enrolled 125 subjects into its European observational registry. The study will continue to enroll additional subjects and expects enrollment to be completed by June 30, 2023. After enrollment, subjects will continue to be seen for follow-up for 12 months post ablation procedure. Complete data results are anticipated to be available in Q4 2024 with interim results available before then.
"When creating this registry, it was specifically designed to see how VIVO is used by physicians in their everyday practice to better understand its accuracy, utility and the long-term benefits that may result from VIVO," said David Jenkins, Executive Chairman. "So far, the data is very promising, and continues to demonstrate the benefits of VIVO. We are excited to share interim results with the physician community in the near future."
The European registry is the first multi-center post market surveillance study conducted for VIVO, a non-invasive mapping technology for ventricular arrhythmias. The study aims to see how VIVO is utilized in a "real world" setting, to gain more insight into the accuracy of VIVO when used in different ways and multiple indications and it will be the first study to look at long-term efficacy in ventricular ablations in conjunction with VIVO.
Catheter Precision's VIVO™ (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE mark.
About Ra Medical Systems
Ra Medical, and its wholly owned subsidiary Catheter Precision, is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.
At the Company
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SOURCE: Ra Medical Systems, Inc.