Cardiva Medical said today it won FDA premarket approval for its Vascade MVP venous vascular closure device.
The Vascade MVP system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said.
The device functions by placing a collapsible mesh disc against the inner vessel wall to stop bleeding followed by a collagen patch and the removal of the mesh disc, the company said. The collagen patch is designed to expand, seal and stop bleeding and is later absorbed by the body.
Cardiva touted the Vascade MVP as the first and only vascular closure system intended for multi-site venous closure, cleared for use with 6 to 12 French inner diameter sheaths.
“We are at the dawn of a new era now for electrophysiology procedures with this trailblazing technology. The improvements we have seen in both patient satisfaction and more efficient hospital workflow make this one of those rare new technologies that produces benefits for all stakeholders,” Dr. Suneet Mittal of Ridgewood, N.J.’s Snyder Center for Comprehensive Atrial Fibrillation at The Valley Hospital said in a prepared statement.
Approval of the device came based on results from the 204-patient Ambulate pivotal trial of the device which met its primary and secondary endpoints of time to ambulation, reductions in total procedure time, reduced time to discharge eligibility, improved patient satisfaction and reduction in the use of opioid pain medications, Cardiva said.
“With the Vascade MVP device, we have been able to get patients safely on their feet hours earlier than previously possible after an ablation for atrial fibrillation or a left atrial appendage closure procedure. In our practice the new Cardiva workflow has freed up staff and beds – and patient satisfaction has skyrocketed with less time spent immobilized on their backs. This new workflow may also make it possible to send more patients home the same day as their procedure,” Dr. Amin Al-Ahmad of the Texas Cardiac Arrhythmia Institute said in prepared remarks.
“Approval of the Vascade MVP System marks the culmination of a multi-year effort by Cardiva to pioneer the first dedicated vessel closure solution for electrophysiology procedures such as cardiac ablation and left atrial appendage closure. We are proud to have partnered with leading EP physicians in the United States to address this unmet need – and enable patients to get back on their feet sooner and improve the workflow for these highly successful procedures. This approval – our second PMA approved product – is an exciting milestone for our team, and shipments to leading centers in the United States have already begun,” Cardiva Medical CEO John Russell said in a press release.
Last month, Cardiva Medical released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints.
