Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
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38 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />
Therapy<br />
Type<br />
Table 12: Overall Atrial Conversion Rate<br />
Patients Success Episodes<br />
Conversion<br />
rate<br />
OPTION Study<br />
ATP 3 3 5 60.0%<br />
HF Burst 17 45 111 40.5%<br />
Shock 12 30 34 88.2%<br />
All<br />
Therapies<br />
25 78 129 60.5%<br />
TACT Study<br />
ATP 29 62 142 43.6 %<br />
HF Burst 49 156 408 38.2 %<br />
Shock 42 84 108 77.8 %<br />
All<br />
Therapies<br />
66 302 542 55.7 %<br />
The overall conversion rate <strong>and</strong> the conversion rates for each therapy<br />
are comparable to the conversion rates observed in the TACT study,<br />
demonstrating that the Tupos LV⁄ATx device has similar atrial conversion<br />
capabilities as the legally marketed Tachos DR – Atrial Tx ICD.<br />
The purpose <strong>of</strong> Secondary Endpoint 2 is to evaluate VT (ventricular<br />
tachycardia) <strong>and</strong> VF (ventricular fibrillation) detection times <strong>of</strong> the<br />
Tupos LV⁄ATx. This is a measure <strong>of</strong> the ability <strong>of</strong> the ventricular detection<br />
algorithm to detect VT <strong>and</strong> VF in an appropriate time frame. This<br />
endpoint was evaluated based on the review <strong>of</strong> electrograms following<br />
induced VT⁄VF episodes. A comparison <strong>of</strong> data from the TACT study that<br />
utilized the legally marketed Tachos DR – Atrial Tx ICD (P000009⁄S4,<br />
dated 09‐09‐2002) to data collected during the OPTION study for the<br />
Tupos LV⁄ATx was performed.<br />
Table 13 summarizes <strong>and</strong> compares the results from these two clinical<br />
studies.
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