ASM 25 - Service Offering Flashcards
What does “PAS” stand for?
Response to a Kestra Key selling message,
“Contemporary Garment: Quality, comfort, built-in bra for women”
LifeVest next generation garment
> 1 Million Patients over a 20-year period!!!
Response to a Kestra Key selling message,
“Reduction in alarms yields better patient compliance”
Arrythmia alarms both false and positive occurred in 72% of the participants w/ 9.6% of the participants being exposed to more than 100 alarms over the 90 day period
What % of LifeVest treatments occur at a rate less than 170bpm?
11%
What Innovation was added in 2018 to LifeVest?
TruVector
56% relative reduction in total arrythmia alarms
0 median false alarms
AArD was designed to reduce an already low rate of false detections
Describe AArD
AArD is a machine learning classifier that determines if input is noise or artifact
Designed to filter additional false detections
caused by non-physiological signal artifact
and noise
When was AArD introduced vs when was AArD standard in all WCDs?
Introduced in 2018; standard in all LifeVest WCDs since 2019
The ASSURE device was approved by the FDA based on two small clinical trials called?
ACE-CONVERT
ACE-DETECT
(One trial was used to
demonstrate treatment efficacy, and a second trial was used to demonstrate appropriate detection)
Neither ASSURE trial used the _________________________.
Neither ASSURE trial used the fully functional, complete commercial system.
ACE-CONVERT consisted of how many patients and in what setting?
13 patients in an EP lab setting
In ACE-CONVERT patients were ____________ into ___________ .
Induced into VT/VF
In ACE-CONVERT patients were induced into VT/VF
while wearing _________________ that were modified to be attached to the ____________.
Adhesive therapy pads that were modified to be attached to the ASSURE device
This study showed that ASSURE had an 83% first shock and 95% second shock success rate
ACE-CONVERT
LifeVest has a consistent ____ first shock success rate in clinical research and real-world use
> 95% first shock success rate
Why is the LifeVest first shock success rate different than ASSURE’s?
Because it’s based on research and real-world use.
Also, it was captured from patients in the real world utilizing our device instead of in an EP lab with a modified device
ACE-DETECT included ____ patients with active ______
ACE-DETECT included 130 patients with active ICDs
ACE-DETECT - Enrolled pts to wear an ASSURE device
with therapies disabled for up to ___ days.
30 days
ACE-DETECT - name the the primary endpoint.
A false positive shock alarm rate
ACE-DETECT - What were the results of this trial?
The study achieved the
primary endpoint of false detections.
Of the 15 VT/VF episodes captured by ICDs, 11 were not detected by ASSURE.
Four were due to patients not wearing the device at the time of the episode and 7 were due
to not meeting the ASSURE detection threshold of 170bpm
ACE-DETECT - name additional endpoints beyond the Primary!
ICD-detected episodes and adverse event rates
What Kestra is incomplete due to lack of enrollment?
ACE-PAS
(FDA required post-approval study)
New advertising from Kestra claims ASSURE to have a >95% first shock success rate. The citation is data
on file and based on the reported n=_______.
n=1651 (26 reported
appropriate shocks)
It should be noted that this is a small sample size
to base a claim
Does the “Freedom of Choice Act” apply to WCD’s?
A case manager focused message is based on misrepresenting the “Freedom of Choice Act” by
stating that it is required that patient must be given a choice of vendor when being offered an WCD. The
Freedom of Choice Act does not apply to WCDs due to differences in the devices and associated clinical
data. It is important that case managers understand that WCDs are not equal
Appropriate Responses for Ordering Process and Speed to Fit:
- Patient-first approach
- Slightly different for each patient (individual coverage policy or ability to pay) because we never want a patient to get an unnecessary bill.
- The LifeVest ordering designed to collect the appropriate information required for
the approval process by payers. - This process has been continuously informed by 20+ years of experience
- The benefit of the process is that patients do not get unexpected large bills after discharge.
- PSR’S - ZOLL has the largest network of medically trained professionals to fit and service LifeVest patients, both before and after discharge.
- ZOLL also offers vast patient resources designed to educate, engage, and motivate the patient throughout their wear.
ZOLL Payor Coverage?
95% of commercially covered lives in the US having in-network access plus 100% of Medicare Part B and >90% of state Medicaid plans
