BIOTRONIK Evia DR, Technical Manual

Page: 49 / 183

Evia Technical Manual 41
S
A F E T Y
There were no complications reported and there was only 1
observation reported; One patient reported feeling fatigued since
the reprogramming of his Protos pulse generator to AxVx. The
patient performed well during the CAEP treadmill, resulting in a
slope of 0.7. After the CAEP treadmill testing, his pacemaker
was reprogrammed to the settings before the AxVx download.
The calculated rate for observations is 0.05 observations per
patient which is within the clinically acceptable rate. This clinical
study demonstrates the overall safety profile of the AxVx
algorithm.
6.3.2.4 Clinical Study Conclusions
BIOTRONIK has shown that the Protos DR/CLS AxVx
rate-adaptive algorithm provides appropriate rate response as
tested during a symptom limited CAEP treadmill test for patients
exhibiting a high percentage of ventricular sensing (99.1% for
13 patients meeting the pre-defined analysis criteria).
6.3.3 Inos
2+
CLS
6.3.3.1 Primary Objectives
The clinical study included evaluation of the safety and
effectiveness of the device.
6.3.3.2 Methods
A total of 129 patients were implanted with the Inos pulse
generator in a controlled, prospective study. The investigation
was conducted at 15 centers. The average patient was a
73 year-old male, with a NYHA Classification of I and Sinus
Bradycardia.
Each patient was followed at hospital discharge and at one,
three and six month post-implant and every 6 months thereafter.
At the one month follow-up a Chronotropic Assessment Exercise
Protocol (CAEP) treadmill test and a 24 hour Holter recording
were performed.