MVP

Question 1

What type of trial was the AMBULATE trial?

Answer 1

• multicenter
• multi-limb
• 1:1 MVP vs MC
• randomized

Question 2

How many centers/hospitals involved?

Answer 2

13 sites
28 physicians “investigators”

Question 3

Total patients involved in the trial

Answer 3

Total = 204
MVP: 100
MC: 102

Question 4

Key Clinical Outcomes

Answer 4

• 3.9 hour Reduction TTA
• 58% Reduction in opioid use
• 63% increase in patient satisfaction

Question 5

MVP Slogan

Answer 5

Early Ambulation. Simple. Proven.

Question 6

MVP indicated Fr size

Answer 6

6-12Fr inner diameter

Question 7

Is MVP a venous or arterial closure device?

Answer 7

Venous

Question 8

What are the groups within the AMBULATE Trial portfolio? How many?

Answer 8

Their are 4 studies within the Ambulate Trial
- Pivotal Study
- IMPACT/Economic Study
- GAP/Access Success Study
- SDD Study

Question 9

AMBULATE Pivotal Trial

Answer 9

Trial held to establish FDA Approval

Question 10

AMBULATE IMPACT
Economic Study

Answer 10

Established economic impact of post procedural early ambulation

“Aka, how much money we save them if they use MVP”

Question 11

AMBULATE CAP
Continued Access Protocol

Answer 11

Single arm, EP cases, 3 sites, 168 patients
Endpoints - foley used, protamine usage, complications

Question 12

AMBULATE Same Day Discharge (SDD)

Answer 12

Evaluation of same day discharge for saving costs

Question 13

Overall MVP success rate during the AMBULATE Trial

Answer 13

97%

Question 14

Hold time for venous closure

Answer 14

2-3min

Question 15

Do we have an ACT cut off?

Answer 15

No, anything over 300 we hold longer (see Vascade titration hold time card)