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www.cardivamedical.com Designed for EP. Proven by EPs. Early Ambulation Simple Proven

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Page 1: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

www.cardivamedical.com

Designed for EP.Proven by EPs.

Early AmbulationSimple Proven

Page 2: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

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

Page 3: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

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

Page 4: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

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

Page 5: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

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

Page 6: Early Ambulation Simple Proven - Cardiva Medical · Simple Designed for EP Procedures Dedicated to mid-bore (6 –12F I.D.) multiple access venous closure2 Bioabsorbable and thrombogenic

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.