SANTA CLARA, Calif.—Cardiva Medical, Inc., in the field of vascular closure, announced today that they have received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication of the VASCADE Vascular Closure System. Previously approved for use in arterial closure, VASCADE is now 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.
“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.”
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. 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.
Results of a study evaluating VASCADE for venous closures were published in Vascular Disease Management. The authors note, “In our institution’s experience with this small case series, under very experienced operators’ supervision, the Vascade vascular closure system can be safely and effectively used for venous access-site hemostasis. This 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. “There are certain limitations to using VCDs for venous closure. Structurally, veins differ from arteries significantly in that the smooth muscle in the tunica media of veins is considerably less dense, and the outer tunica adventitia is thinner. This arrangement provides veins with improved compliance when compared with arteries, but also results in a wall that is structurally weaker, with a less effective recoil mechanism. The low flow/pressure of the venous circulation (which increases the likelihood of thrombosis if exposed to foreign materials) makes extravascular VCDs more suitable for venous closure than devices that utilize intravascular components…[W]e have tried several methods for venous hemostasis over the past decade, and nothing has consistently been as effective and easy to use as the Vascade VCD.”
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.
“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.”