Guidant Corp. Begins Enrollment in SPIRIT II Drug-Eluting Stent Clinical Study

Guidant Corp. has initiated enrollment in the SPIRIT II clinical study, a 300-patient trial evaluating its XIENCE V everolimus-eluting coronary stent system. This study will compare the effectiveness of XIENCE V to the TAXUS Express 2 Paclitaxel Eluting Coronary Stent System in treating coronary artery disease. The results of the study will provide additional data to support the launch of XIENCE V in several countries outside the United States. The first patient was enrolled by Dr. Gert Richardt of Segeberger Kliniken, GmbH, in Germany.

Key Takeaways:

• The SPIRIT II study is a 300-patient, single-blind, randomized, controlled trial evaluating the XIENCE V everolimus-eluting coronary stent system.
• The study will compare the effectiveness of XIENCE V to the TAXUS Express 2 Paclitaxel Eluting Coronary Stent System in treating coronary artery disease.
• The results of the study will provide additional data to support the launch of XIENCE V in several countries outside the United States.
• Guidant recently announced the initiation of SPIRIT III, a large-scale, pivotal, clinical trial evaluating XIENCE V in the United States.
• XIENCE V is an everolimus-eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION Coronary Stent System platform.

Statistics:

• 300 patients will be enrolled in the SPIRIT II clinical study.
• The study will compare the effectiveness of XIENCE V and TAXUS Express 2 Paclitaxel Eluting Coronary Stent System in treating coronary artery disease.
• The SPIRIT III study will be a large-scale, pivotal, clinical trial evaluating XIENCE V in the United States.

Sources:

• "Guidant Announces Initiation of SPIRIT II Clinical Trial for XIENCE V Stent." Hematology Week, 2005.