Cardiva Medical Announces FDA Approval of VASCADE Vascular Closure System for Use in Femoral Vein Closure

Cardiva Medical announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication of the VASCADE Vascular Closure System. Already approved for use in arterial closure, VASCADE is now FDA approved for use in 5-7F femoral venous closures as well. This expansion creates an opportunity to better treat patients undergoing interventional cardiac catheterization procedures, while also greatly increasing the available market for VASCADE.

The VASCADE System consists of a thrombogenic bioabsorbable collagen patch and proprietary collapsible disc technology that is clinically proven to safely and effectively achieve hemostasis (stoppage of bleeding) while minimizing complications. Unlike manual compression, which is the current standard for femoral access site closure, VASCADE does not require prolonged, heavy pressure and extended bed rest to ensure hemostasis.

“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, M.D., chief of invasive cardiology at Englewood Hospital and Medical Center in New Jersey. “Successful vessel closure, and enabling a patient to walk as soon as possible after their procedure, are critical factors for recovery from interventional procedures. The ease of use of the VASCADE system and its compelling clinical data will make it an attractive new option for closure following vein procedures.”

Results of a study evaluating VASCADE for venous closures were published in Vascular Disease Management. The authors noted 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 emphasize that access site complications remain the most common complication from cardiac catheterization procedures that require venous access.

“This expanded indication is an exciting milestone for Cardiva Medical, as it expands our market potential and further differentiates our company and our innovative technology,” said John Russell, Cardiva’s president and CEO. “We are pleased that the new indication will allow us to extend the proven benefits of VASCADE closure to a broader group of patients.”