User's Manual

Cardiac Airbag Technical Manual 17
1.6 Clinical Studies
N
OTE:
The Phylax XM ICD is an earlier generation of BIOTRONIK
devices. The Cardiac Airbag family is based upon the
Phylax XM and other BIOTRONIK ICDs (i.e., Belos VR and
Belos VR-T).
This clinical study was performed on the Phylax XM and
Phylax 06 ICDs, which are earlier versions of the Cardiac
Airbag ICD. The clinical study data presented here is applicable
because the Cardiac Airbag / Cardiac Airbag-T is a downsized
version of the Phylax XM with the addition of rate adaptive
pacing capabilities. The Cardiac Airbag / Cardiac Airbag-T ICDs
are slightly different as compared to the Phylax XM in the
following areas:
• Motion based rate adaptive pacing
• Reduced programmable feature set
• Minor adjustments to therapy delivery options including
no availability of ATP
• Reduced size from 69 cc to 39 cc
• Addition of Home Monitoring functionality
The rate adaptive pacing circuitry of Cardiac Airbag / Cardiac
Airbag-T ICD is based on other US distributed BIOTRONIK
products. Due to the similarities between the Cardiac Airbag /
Cardiac Airbag-T, Belos VR / VR-T, and Phylax XM and the
limited nature of these changes, a clinical study of the
Cardiac Airbag / Cardiac Airbag-T ICD was determined to be
unnecessary.
1.6.1 Patients Studied
The clinical study involved 154 patients (121 male and 33
female) with a mean age of 64.9 years (range: 26 to 95 years)
and a left ventricular ejection fraction of 33% (range: 10% to
80%). Most (72%) presented with coronary artery disease /
ischemic cardiomyopathy; 71% presented with monomorphic
ventricular tachycardia (MVT) as their primary tachyarrhythmia.