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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30 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />
1.6.2.3 Summary <strong>of</strong> Clinical Results<br />
A total <strong>of</strong> 200 patients were enrolled in the OPTION CRT⁄ATx clinical<br />
study at 25 sites:<br />
There were 133 study patients <strong>and</strong> 67 active control patients in this<br />
prospective, multi‐center, r<strong>and</strong>omized clinical study. For the study<br />
group, there were 129 successful implants (91.4%) <strong>of</strong> the Tupos LV⁄ATx<br />
CRT‐D system. For the active control group, there were 64 successful<br />
implants (92.2%) <strong>of</strong> the legally marketed CRT‐D systems.<br />
Patient Accountability<br />
After r<strong>and</strong>omization <strong>and</strong> enrollment, 7 patients (4 in the study group<br />
<strong>and</strong> 3 in the control group) did not receive an implant. The reasons for<br />
patients not receiving an implant are outlined in Figure 3.
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