early ambulation simple proven - cardiva medical · simple designed for ep procedures dedicated to...
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www.cardivamedical.com
Designed for EP.Proven by EPs.
Early AmbulationSimple Proven
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Evolution of AF Ablation Workflow
PAST Long Procedure & Post-procedure Time
Procedure Time Post-procedure Time
PRESENT Procedure Innovations
WITH VASCADE MVPCardiva Workflow Innovations
6–8 hours
• Heparin reversal and ACT recovery• Manual compression• Prolonged bed rest
6–8 hours
• No change• Impact on patient quality of life• Impact on hospital cost• Contributing factor to overnight stay
2–3 hours
• Shorter time to ambulation3
• Improved patient satisfaction3
• Reduced utilization of opioids3
• Potential for earlier discharge3
6–8 hours
1–3 hours
1–3 hours
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Early AmbulationA New Era Introducing VASCADE MVP® VASCULAR CLOSURE FOR EP1 PROCEDURES
VASCADE MVP eliminates the need for manual compression and reduces time to ambulation by 64%.2
Get patients up and moving hours earlier, with significantly less discomfort.3
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Manual Compression
Time to Ambulation median 6.1 hrs3
Last Access Site Closure
Ambulation
VASCADE MVP
Time to Ambulation
median 2.2 hrs3
Last Access Site Closure
Ambulation
63%IMPROVEMENT
41%IMPROVEMENT
58%REDUCTION
SimpleDesigned for EP Procedures
Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2
Bioabsorbable and thrombogenic collagen plug – Expands to fill
tissue tract
Simple and easy to use– Single operator– No sutures or material
left in the vessel
Extravascular design – No permanent or
intraluminal implants
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Manual Compression
Time to Ambulation median 6.1 hrs3
Last Access Site Closure
Ambulation
VASCADE MVP
Time to Ambulation
median 2.2 hrs3
Last Access Site Closure
Ambulation
63%IMPROVEMENT
41%IMPROVEMENT
58%REDUCTION
ProvenProven by EPs
Comparison of Bedrest for Patients
with a Previous Cardiac Ablation
Procedure3
Manual Comp = 5.6 vs. VASCADE MVP = 7.9 mean5
All Patients3
Manual Comp = 5.1 vs. VASCADE MVP = 8.3 mean5
VASCADE MVP was evaluated in the AMBULATE pivotal trial. AMBULATE was a multicenter, randomized clinical trial with 204 patients randomized 1:1 to VASCADE MVP or manual compression. −3.9 hours
Number of Patients Receiving Opioids Post-Procedure3
Manual Comp = 37 ptsVASCADE MVP = 15 pts
Patient Satisfaction with Duration of BedrestOpioid Use
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Ordering Information
The VASCADE MVP Venous Vascular Closure System (VVCS) Model 800-612C is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6–12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.
CONTRAINDICATIONS: The VASCADE MVP VVCS should not be used in patients with a known allergy to bovine derivatives.
Before use, physicians should review all risk information, which can be found in the “Instructions for Use.”
Founded in July 2002, CARDIVA Medical Inc. is a privately held medical device company that is focused on developing and commercializing innovative vascular closure technologies designed to help the body heal itself.
P: 866.602.6099 F: 866.602.1795customerservice@cardivamedical.comwww.CardivaMedical.com
2018© Cardiva Medical, Inc. VASCADE MVP is a registered trademark of Cardiva Medical, Inc. Lit 4344 Rev B
PRODUCT CATALOG NUMBER DESCRIPTION QUANTITY
VASCADE MVPVenous Vascular ClosureSystem (VVCS)
800-612C-10U 6–12 French (Inner Diameter)
1 box (10 devices per box)
1. Electrophysiology (EP) 2. Percentage difference in median time to ambulation as reported
in the IFU.3. As demonstrated in the AMBULATE pivotal trial.4. IFU and/or SSED for Vascade MVP.5. On a scale of 0 – 10, with 0 being the
worst and 10 being the best.