GDT Guidant Corp

Guidant Corporation (NYSE:GDT) today announced enrollment of the first patient in a first-in-man clinical trial designed to evaluate the safety of a fully bioabsorbable everolimus eluting stent platform for the treatment of coronary artery disease. The trial, called ABSORB, will enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. "As the world's first clinical trial evaluating a fully bioabsorbable drug eluting coronary stent, this initial implant marks a significant milestone for Guidant. This study will lay the foundation for our continued work toward offering a valuable alternative to current drug eluting stent implants that reside permanently in the treated coronary artery," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "We are excited about our bioabsorbable drug eluting stent program, which is aligned with Guidant's strategy of leveraging bioabsorbable technologies to provide innovative site-specific therapy for the treatment of heart disease." The ABSORB trial will study the safety of bioabsorbable drug eluting stents developed by Bioabsorbable Vascular Solutions, an entrepreneurial subsidiary of Guidant Vascular Intervention established in 2003 in the Silicon Valley. These stents are designed to be fully absorbed by vascular tissue following the restoration of blood flow and drug elution in patients with coronary artery disease. Guidant has completed extensive preclinical studies on its bioabsorbable stent, gathering data on safety, drug dosing, and the mechanical properties of the stent. The ABSORB clinical trial is a non-randomized study with an initial assessment of safety (MACE and stent thrombosis rate) at six months and a follow-up period of five years. The first implant was performed by a team headed by Drs. John Ormiston and Mark Webster at Auckland City Hospital, New Zealand. Dr. Ormiston and Professor Patrick Serruys, of the Thoraxcenter, Erasmus University Hospital, Rotterdam will serve as the study's co-principal investigators. "With patients receiving an ever-increasing number of coronary stents in more challenging vessel anatomies, we need clinical solutions that reduce the amount of permanent metallic stent platforms being implanted, and provide for increased flexibility in monitoring and treating patients over an extended period of time," said Dr. Ormiston. "We are highly encouraged by the progress thus far with Guidant's bioabsorbable technology, and look forward to further exploring its potential as part of the ABSORB trial." Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Guidant develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com. NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. This release includes forward-looking statements. The statements are based on assumptions about many important factors, including the company's expectations concerning the clinical data that will result from the trial, and other factors identified in Item 1A of the company's most recent filing on Form 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.