FALL POA - GDMT Trials

Question 1

BELIEF (skin AEs: allergies/nickel) Heard that LifeVest that has a higher rate of skin irritation and LifeVest has exposed nickel that touches the patient’s skin

Answer 1

LifeVest does not contain exposed nickel

Has the other WCD representative shown you any published data on their
adverse event rates?

In ACE-DETECT patients were excluded from the trial if they had known skin allergies, sensitivity to garment materials, and those with existing breached or compromised skin on the upper body.

Still, 34% of patients wearing Kestra experienced an adverse event (AE) with 25% of patients reporting skin-related AE in only 30-days of wear.

Question 2

BELIEF (4-leads vs 2 leads): 4-leads provide better detection and 4-leads are more accurate at differentiating appropriate from inappropriate detections.

Answer 2

LifeVest is 97% sensitive to VT and 100% sensitive to VF with 100% specificity to both VT and VF.”

Question 3

BELIEF (Inappropriate Alarms): The
ASSURE device has much fewer inappropriate alarms than LifeVest.

Answer 3

LifeVest’s low inappropriate shock rate in published clinical trials is <1% per month, with a
default VT threshold of 150 bpm.

Question 4

BELIEF (170J vs 150J): There is a difference between ASSURE’s 170J vs LifeVest’s 150J.

Answer 4

LifeVest has extensive peer reviewed published data on over 20,000 patients, demonstrating
>95% first shock success and 96% 1-year survival at 150J.”