Guidant Corporation has announced enrollment of the first patient into the ABSORB study, to evaluate the safety of Guidant’s proprietary fully bioabsorbable everolimus eluting stent for the treatment of coronary artery disease.
The press release comments on the stent technology and trial:
… 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.”