• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	7 yr	8 yr	9 yr	at 117 mo
%		99.5	99.4	99.4	99.1	99.1	97.9	97.9	97.9	97.9	97.9
#		656	513	387	318	274	202	157	116	76	49

System Longevity Study Results

Number of Leads Enrolled in Study	967
Cumulative Months of Follow-Up	39207
Number of Leads Active in Study	92

9

Qualifying Complications

Failure to Capture	6
Failure to Sense	1
Impedance Out of Range	1
Lead Dislodgement	1

ATRIAL PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	7 yr	8 yr	9 yr	10 yr
%		99.5	99.5	99.5	99.5	99.5	99.5	99.5	99.5	99.5	99.5
#		408	385	357	322	284	246	208	155	93	50

System Longevity Study Results

Number of Leads Enrolled in Study	424
Cumulative Months of Follow-Up	33362
Number of Leads Active in Study	156

2

Qualifying Complications

Failure to Capture	1
Lead Dislodgement	1

Advisories For This Model

• There are no advisories for this model.

Performance Notes For This Model

• Tests and Observations for Clinical Assessment of Chronic Pacing Leads