Biotronik completes enrolment for Spirit-ICD study
6 July 2012 15:06 in Medical Company Product News
Biotronik has announced the completion of enrolment of its implantable cardioverter defibrillator (ICD) study Spirit-ICD, with 503 patients in 11 countries now registered.
The trial is designed as a follow-up to Madit II, an earlier study which showed that patients receiving treatment using an ICD that was implanted for primary prevention had a significantly increased risk for all-cause mortality.
Spirit-ICD aims to investigate whether this high-risk group might benefit from an intensified diagnostic follow-up and timely therapeutic intervention, with patients to be tracked for at least a year using the Biotronik Home Monitoring system.
Christoph Bohmer, managing director at Biotronik, said: "The Spirit-ICD study will enhance our body of knowledge of ICD therapy and provide valuable insights into how early intervention after an appropriate shock may be beneficial to the patient."
This comes after the firm recently announced encouraging data from 4Ever, a clinical study assessing the efficacy of the Pulsar stent system among 120 superficial femoral artery patients.
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