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

 Cardiva Medical, Inc.®, an innovator in the field of vascular closure, today announced 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.1

"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."

About the VASCADE Vascular Closure System and RESPECT Study

VASCADE is a fully integrated, extravascular, bioabsorbable femoral access closure system that is easy to use, leaves no permanent components behind, and has demonstrated safety and efficacy in a wide range of patients. The system combines Cardiva’s proven proprietary collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design. For patients and healthcare providers, VASCADE enables secure and rapid hemostasis while minimizing complications, including bleeding at the access site.

VASCADE works by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue and then removing the mesh disc. The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required.

VASCADE is the only closure system to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care in a prospective, randomized, controlled clinical trial called RESPECT. The RESPECT study included 420 patients at 20 U.S. centers, comparing VASCADE to manual compression for femoral arterial closure, the current standard of care for vascular closure for patients undergoing percutaneous procedures through the femoral artery.2 VASCADE is commercially available in the United States, where it has been approved by the FDA (2013), and has received CE Mark (2012).

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