Multi-Site Closure System Simplifies Electrophysiology Procedures

A new system uses resorbable collagen patches for multi-site vessel closure following electrophysiology procedures, such as cardiac ablation and left atrial appendage (LLA) closure.

The Cardiva Medical (Sunnyvale, CA, USA) Vascade MVP system is a fully integrated, extravascular system that combines collapsible disc technology and thrombogenic collagen hemostatic patches to accelerate coagulation at femoral artery access sites. The small, collapsible bi-convex low profile nitinol mesh disc is first placed against the inside of the vessel wall to temporarily stop the bleeding. A collagen patch is then released into the tissue tract, expanding approximately 13 times, and the mesh disc is then removed.

The expanded collagen ensures the residual tissue tract is sufficiently filled following completion of the electrophysiology procedure; nothing is left behind inside the vessel, and the collagen outside the vessel wall is rapidly resorbed, enabling future access procedures. Vascade MVP has been shown to reduce time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients undergoing catheter-based procedures utilizing 6-12F inner diameter procedural sheaths, with single- or multiple-access sites in one or both limbs.

“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,” said John Russell, CEO of Cardiva Medical. “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.”

“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,” said Amin Al-Ahmad, MD, of the Texas Cardiac Arrhythmia Institute (Austin, USA). “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.”

Since 1959, physicians have been using the Modified Seldinger Technique to insert flexible catheters into the femoral artery of patients to perform procedures in the arterial-vascular system. The most prevalent such procedure, diagnostic angiography, is thought to be performed more than 500,000 times per month worldwide. At the end of every such case, each patient is left with a substantial hole in the femoral artery, which typically takes significant effort and catheterization laboratory resources to close.

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