FDA Approves Expanded Indication for Vascade Vascular Closure System

News

Submitted on Sun, 04/01/2018 - 11:03
FDA

The FDA has approved an expanded indication of the Vascade Vascular Closure System, according to an announcement by Cardiva Medical. The new indication allows use of Vascade in 5-7F femoral venous closure. The device had already been approved for use in arterial closure.

Last year, the results of a study assessing Vascade for venous closures were published in Vascular Disease Management. The authors stated that the “device achieved complete hemostasis without any recorded vascular complications and was effective in providing earlier ambulation and discharge compared with our standard protocol for manual compression.” In the same article, the authors said that access site complications remain the most common complication from cardiac catheterization procedures that require venous access.

Vascade aims to reach hemostasis through use of a thrombogenic bioabsorbable collagen patch and proprietary collapsible disc technology. Prolonged, heavy pressure from manual compression and extended bed rest are not required to ensure hemostasis with the use of Vascade. Additionally, no permanent components are left behind.

“Vascade has performed exceptionally well for our current patients, and this new indication will empower many physicians to use Vascade for vein closure," said Joseph De Gregorio, MD, chief of invasive cardiology at Englewood Hospital and Medical Center in New Jersey.

References

Cardiva Medical® Announces FDA Approval of VASCADE® Vascular Closure System for Use in Femoral Vein Closure. Businesswire. April 5, 2018. Press release. Santa Clara, California.

Nagabandi A, Ratanapo S, Garrison Morgan L, Kapoor D. Use of Vascade Vascular Closure System for Venous Hemostasis.  Vascular Disease Management. 2017;14(8):E171-E173.