FDA approves venous indication for VASCADE closure system

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Cardiva Medical, a vascular closure device company, today announced it has received approval from the US Food and Drug Administration (FDA) for an expanded indication of the VASCADE Vascular Closure System. Already approved for use in arterial closure, the closure system 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 catheterisation procedures, while also greatly increasing the available market for the device.

The system consists of a thrombogenic bioabsorbable collagen patch and proprietary collapsible disc technology that is clinically proven to safely and effectively achieve hemostasis while minimising complications. Unlike manual compression, which is the current standard for femoral access site closure, the device 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,” says Joseph De Gregorio, chief of invasive cardiology at Englewood Hospital and Medical Center in Englewood, USA. “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 the system for venous closures were published in Vascular Disease Management. The authors noted that the “device achieved complete haemostasis 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 emphasise that access site complications remain the most common complication from cardiac catheterisation procedures that require venous access.

VASCADE Vascular Closure System and RESPECT Study

The company markets its closure system as a fully integrated, extravascular, bioabsorbable femoral access closure system that is easy to use and leaves no permanent components behind. It has demonstrated safety and efficacy in a wide range of patients. The system combines Cardiva’s collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design.

The system 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, randomised, controlled clinical trial called RESPECT. The RESPECT study included 420 patients at 20 US centres, comparing the system to manual compression for femoral arterial closure, the current standard of care for vascular closure for patients undergoing percutaneous procedures through the femoral artery.

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