Cardival Medical, Inc. news

SANTA CLARA, Calif., July 16, 2020 -- Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced the first patient enrollments in its AMBULATE Same Day Discharge study, the first prospective multi-center study designed to evaluate same-day discharge for patients undergoing cardiac ablation procedures for atrial fibrillation. The study is utilizing the VASCADE MVP Venous Vascular Closure System, which received U.S. Food and Drug Administration (FDA) approva

Santa Clara, Calif. - October 30, 2019 - Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that positive results from the AMBULATE pivotal study demonstrating the safety and efficacy of the company’s VASCADE^® MVP Venous Vascular Closure System compared to manual compression were published online in the Journal of the American College of Cardiology: Clinical Electrophy

• VASCADE MVP is the first vessel closure technology designed for electrophysiology procedures – and proven by electrophysiology physicians in a multi-center, randomized, controlled clinical trial.
• Potential procedures include cardiac ablation and left atrial appendage closure among others.
• Greater than 400,000 patients per year in the United States may benefit – with procedures growing double digits each year.

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• The AMBULATE pivotal study met its primary efficacy endpoint. The median time to patients getting on their feet following arrhythmia ablation procedures was reduced by 3.9 hours.
• AMBULATE demonstrated that patients in the VASCADE MVP arm had significantly improved patient satisfaction and a significant reduction in the post-procedure use of opioid pain medications.
• Late-breaking results were presented at the American Heart Association 2018 Scientific Sessions.