Performance Update for Sprint Fidelis® Leads
(Models 6930, 6931, 6948, 6949)
This attachment accompanies Medtronic’s physician letter dated October 15, 2007 and provides performance information on Sprint Fidelis leads. Below are the current performance data for Sprint Fidelis Model 6949 using Returned Product Analysis (RPA), System Longevity Study (SLS), and data from the Medtronic CareLink® Network. Refer to Appendix A for descriptions of the datasets.
Survival probability of Fidelis Model 6949 at 30 months was estimated using the RPA, SLS, and CareLink Network datasets. Survival at 30 months per RPA, SLS, CareLink Network datasets is 99.2%, 97.7% and 97.7%, respectively. Ranges shown in the graph designate 95%confidence interval. CareLink Network data offers a relatively large sample size at the leading edge. 95% Confidence range for SLS data is relatively large due to limited sample size at the leading edge (see table). CareLink dataset analysis overcomes this limitation.
Performance of Sprint Fidelis Model 6949 lead compared to other Medtronic ICD leads (Sprint Quattro Model 6947, Sprint™ Model 6945, and Transvene™ Model 6936). Cumulative survival based on Medtronic’s SLS.
We continue to analyze data in various subsets in order to determine possible factors influencing performance. The SprintFidelis Model 6949 survival rate at 30 months for different patient age groups is as follows. In patients 58 years of age and older, SprintFidelis 30-month survival rate is statistically better than in patients under 58 [98.4% versus 97.5%, respectively, with a 90% confidence interval], as determined by RPA and CareLink™ Network datasets. In patients under the age of 21, the Sprint Fidelis 30-month survival rate is statistically lower than Sprint Quattro® [96.2% versus 99.4%, respectively, with a 95% confidence interval] based on RPA; however, because of sample size limitations we cannot confirm this difference with the SLS or CareLink Network dataset.
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