Early Ambulation. Simple. Proven.
VASCADE MVP® enables Early Ambulation, is simple to use and proven, providing femoral venous closure in patients who have undergone catheter-based interventions using procedure sheaths with an Inner Diameter of 6 to 12 French.
In the prospective, multi-center, randomized clinical trial called AMBULATE, VASCADE MVP demonstrated the following results compared to Manual Compression (MC)1:
- Reduced median Time to Ambulation (TTA) by 64% (3.9 hours) (p-value < 0.0001), improving both patient satisfaction and introducing the opportunity for post-AF ablation workflow efficiencies.
- Patients prefer VASCADE MVP®*
- +63% for duration (p-value < 0.0001)
- +36% for discomfort (p-value < 0.0001)
- +25% for pain (p-value = 0.0001)
- Use of opioids reduced by 58% with VASCADE MVP** (nominal p-value = 0.001)
The product is simple and easy to use:
- Single operator - No sutures
- Extravascular design – No permanent or intraluminal implants
- Bioabsorbable thrombogenic collagen plug – Expands to fill tissue tract
VASCADE® Minimizes Complications, Maximizes Hospital Efficiencies and Improves Patient Care
Bleeding and other vascular complications can have a substantial economic impact on costs for hospitals, adding incremental cost and increased length of stay based on severity. Cardiva products offer a safe and effective alternative to manual compression for femoral arterial or femoral venous access site closure.
VASCADE has demonstrated enhanced safety and efficacy, helping to minimize complications and maximize hospital efficiencies. VASCADE optimizes vascular access management through:
- Promotion of rapid hemostasis with very low complication rates2
- Leaves no permanent component behind
- Can be used in interventional and diagnostic procedures
- Faster hemostasis even in heparinized blood3
In Studies, Cardiva CATALYST® Demonstrated Improvement in TTH and TTA4
In studies, Cardiva CATALYST Manual Compression Assist Device have shown to improve time to ambulation (TTA) and time to hemostasis (TTH), making the process more efficient for hospital staff and more comfortable for patients.
* Nominal p-values by two-sided t-test, not pre-specified, however actual results imply superiority
** Nominal p-values by two-sided Fisher's exact test, not pre-specified, however actual results imply superiority
1 VASCADE MVP® IFU and/or SSED | 2 RESPECT IDE Trial utilized for PMA Approval | 3 Data from BOOM II Investigator-Initiated Clinical Study with manuscript submitted for publication. Note: FDA has not reviewed reduced TTH or TTA data. | 4 Porcine blood was heparinized to 0.42 IU of Heparin /1ml of blood. Data on file.
