Cardiva Medical 800-612C-05U Vascade MVP Venous Vascular Closure System BX/5

Cardiva Medical 800-612C-05U Vascade MVP Venous Vascular Closure System BX/5

• Model: 800-612C-05U
• for 6F-12F I.D.
• 12cm Length Sheaths 
• Box of 5

This medical supply or implant item is securely packaged within its original manufacturer's packaging, which remains undamaged. The inner and outer packaging is intact, ensuring the product's integrity and suitability for medical use.

The Cardiva Medical 800-612C-05U Vascade MVP Venous Vascular Closure System is a fully integrated, extravascular, bioabsorbable femoral access closure system. It is specifically designed for the percutaneous closure of femoral venous access sites following catheter-based procedures. The system utilizes a collapsible mesh disc to temporarily stop bleeding by placing it against the inside of the vessel wall. Subsequently, a resorbable collagen patch is released into the tissue tract to achieve hemostasis. This design ensures that no permanent components are left behind, allowing for future access to the vessel if additional procedures are required.

Paragraph 2 – Clinical Applications and Benefits
The Vascade MVP system is indicated for use with 6F to 12F inner diameter procedural sheaths, making it suitable for a range of electrophysiology procedures, including cardiac ablation and left atrial appendage closure. Clinical studies have demonstrated that the system significantly reduces time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility. Additionally, patients treated with the Vascade MVP system reported improved satisfaction scores and a reduction in the use of opioid pain medications, highlighting its effectiveness in enhancing patient recovery and comfort.

Paragraph 3 – Regulatory Approval and Market Position
Cardiva Medical received premarket approval (PMA) from the U.S. Food and Drug Administration for the Vascade MVP Venous Vascular Closure System, based on the results of the AMBULATE Pivotal Trial, a 204-patient, 13-site randomized, controlled study. This approval underscores the system's safety and efficacy in clinical settings. The Vascade MVP is the first and only vascular closure system designed and labeled specifically for multi-site venous closure with 6F to 12F inner diameter sheaths, positioning it as a leading choice for vascular closure in electrophysiology procedures.