Cardiva Medical has received the CE mark for its Vascade MVP venous vascular closure system. Additionally, the AMBULATE study has been published in JACC: Clinical Electrophysiology. According to a press release, the AMBULATE study demonstrates the safety and efficacy of the system compared with manual compression. The press release adds that in both the USA and Europe, Vascade MVP is the first and only vascular closure system designed and labelled specifically for multisite venous closure following electrophysiology procedures.
Vascade MVP, the press release reports, uses a simple and proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure. The aim is to leave nothing behind inside the vessel, and the collagen outside the vessel wall is designed to be resorbed in a short period of time—enabling re-access for future procedures. The system’s multisite access approach and size range, using 6-12F inner diameter sheaths, is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.
John Russell, CEO of Cardiva Medical, comments: “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 USA. 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.
Andrea Natale (Texas Cardiac Arrhythmia Institute, Austin, USA), one of the study’s principal investigators, says: “The use of Vascade MVP is a transformative new option for electrophysiology that has demonstrated more efficient workflow in the electrophysiology lab and higher levels of patient satisfaction. 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.”