Cardiva Medical has said that results from the AMBULATE pivotal study demonstrate the safety and efficacy of its VASCADE MVP venous vascular closure system compared to manual compression. The results were published online in the Journal of the American College of Cardiology: Clinical Electrophysiology. The company also announced that it has received CE Mark certification for VASCADE MVP in Europe.
“Publication of the AMBULATE study results in a respected peer-reviewed journal is a major milestone for Cardiva – and reinforces the value of VASCADE MVP for patients undergoing electrophysiology procedures,” said John Russell, CEO of Cardiva Medical. “Since receiving PMA approval from the FDA in late 2018, VASCADE MVP has been adopted as part of the workflow in more than 100 leading electrophysiology centres across the US. We are thrilled with the reception from physicians, and with the results we are seeing with this technology to help patients get back on their feet faster after procedures such as cardiac ablation and left atrial appendage closure.”
The AMBULATE pivotal study is a randomised, controlled study of 204 patients across 13 sites treated with the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and significantly reduced use of opioid pain medications.
“The use of VASCADE MVP is a transformative new option for electrophysiology that has demonstrated more efficient workflow in the EP lab and higher levels of patient satisfaction,” said Andrea Natale (Texas Cardiac Arrhythmia Institute, Austin, USA), who was among the principal investigators in the study. “Manual compression is time-consuming and painful for the patient. Using this technology elevates the level of care we offer our patients by allowing them to get back on their feet safely and quickly, potentially leave the hospital earlier, and even take less opioids to relieve their post-procedural pain. The publication of these data further proves the value of this technology for both physicians and their patients.”
VASCADE MVP uses a proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure. Nothing is left behind inside the vessel, and the collagen outside the vessel wall is resorbed in a short period of time enabling re-access for future procedures. VASCADE MVP’s multi-site access approach and size range using 6-12 French inner diameter sheaths is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.