CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trial, studies, and data updates reported in Medical Device News Magazine.
Volta Medical Announces Completion of Patient Enrollment in TAILORED-AF Clinical Trial for Treatment of Atrial Fibrillation
The TAILORED-AF clinical trial is an international, multicenter, randomized controlled study designed to confirm the clinical significance of VX1 and lay the groundwork for establishing VX1 as a new standard of care for persistent AF ablation.
The study, published in the journal Stereotactic and Functional Neurosurgery, successfully established minimally clinical important difference ranges for the insomnia severity index outcome measure to help gauge improvement in insomnia after spinal cord stimulation.
The findings show that Vista.ai’s AI-guided image acquisition software improves cardiac MRI (CMR) scan times and achieves high adoption rates by hospital imaging staff. Dr. Kwong will discuss the learnings and implications of the study at an interactive breakfast symposium at 7:20 a.m. PST on Jan. 27, 2023, at the SCMR Scientific Sessions in San Diego.
MedAlliance Leads US Sirolimus DEB race: First US Patient enrolled into SELUTION SLR Coronary Sirolimus DEB Study
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials. Centres interested in participating in this study, please contact MedAlliance.
In the new VEXAS syndrome study, publishing in the Journal of the American Medical Association (JAMA) online Jan. 24, researchers analyzed the electronic health records of 163,096 mostly white men and women in Pennsylvania who agreed to have their blood DNA screened for signs of genetic disease. Twelve were found to have the UBA1 mutation, with all experiencing VEXAS symptoms.
Ra Medical Systems Announces the Presentation of Clinical Data at the European Heart Rhythm Association Congress
David Jenkins, Ra Medical Systems Executive Chairman. “All four abstracts with VIVO clinical data submitted by leading physicians to the Congress were accepted for presentation following an extensive peer-review process. To have one-hundred percent acceptance of submitted abstracts is rare and I believe indicative of the positive impact VIVO is having on ventricular ablation procedures. We view this recognition as a major milestone in gaining clinical acceptance by both EP thought leaders and the larger medical community.”