• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	7 yr	at 93 mo
%		99.7	99.5	99.5	99.5	99.5	99.5	99.5	99.5
#		541	388	329	304	242	154	85	47

System Longevity Study Results

Number of Leads Enrolled in Study	956
Cumulative Months of Follow-Up	30769
Number of Leads Active in Study	691

3

Qualifying Complications

Failure to Capture	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	at 90 mo
%		99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1
#		200	189	183	171	146	112	73	52

System Longevity Study Results

Number of Leads Enrolled in Study	214
Cumulative Months of Follow-Up	14960
Number of Leads Active in Study	137

2

Qualifying Complications

Failure to Sense	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