Lumax Family of ICDs and CRT‑Ds - BIOTRONIK USA - News

18 Lumax Family Technical Manual
Table 3: Summary of Observations—Kronos LV‐T
Category
# of
Pts
% of
Pts
# of
Complications
Complications
Per pt‐year
Worsening CHF 2 4.4% 2 0.12
Elevated RV pacing
threshold
1 2.2% 1 0.06
Hepatitis 1 2.2% 1 0.06
Arrhythmias 1 2.2% 1 0.06
Cardiac
Decompensation
1 2.2% 1 0.06
All Observations 23 51.1% 26 1.54
Number of Patients = 45, Number of Patient‐Years = 16
Two patient deaths were reported during the HOME‐CARE Observational
Study. One death resulted from worsening heart failure and the second
death resulted from cardiogenic shock due to ischemic cardiomyopathy.
None of the deaths were related to the implanted CRT‐D system. There
were no device explants during the HOME‐CARE Observational Study.
1.5.2.2 Tupos LV⁄ATx Study
NOTE:
The clinical study information included in this Section and in
Section 1.6.2 was performed with the Tupos LV⁄ATx CRT‐D, which
is an earlier version of the Lumax CRT‐D⁄ICD families. The clinical
study data presented here is applicable because the Lumax family
are downsized versions of the Tupos LV⁄ATx CRT‐D and Tachos ICD
families. The Lumax family is slightly different as compared to the
Tupos LV⁄ATx (and Tachos family) in the following areas:
--
Reduced size from 50⁄48 cc to 40⁄35 cc
--
Addition of Home Monitoring functionality
--
Addition of triggered pacing for biventricular pacing modes
--
True three chamber pacing and sensing capabilities (CRT‐Ds)
The OPTION CRT⁄ATx study was a prospective, randomized, multi‐center
study to demonstrate the safety and effectiveness of the investigational
Tupos LV⁄ATx Cardiac Resynchronization Therapy Defibrillator (CRT‐D) in
patients with congestive heart failure (CHF) and atrial tachyarrhythmias.