First clinical trial data of fully bioabsorbable drug-eluting stent publishedMarch 14th, 2008 - 1:30 pm ICT by admin
London, March 14 (ANI): The results of the worlds first clinical trial on a fully bioabsorbable drug eluting stent show that 30 patients treated with it had a low rate of major adverse cardiac events (MACE), and no event of thrombosis through one year.
Published in the journal The Lancet, the one-year results for Abbott’s bioabsorbable everolimus eluting stent were consistent with performance demonstrated by the system at six months, as previously reported in October last year.
ABSORB, the clinical trial, is designed to evaluate the overall safety and performance of a fully bioabsorbable everolimus eluting stent out to five years.
“Abbott’s bioabsorbable everolimus eluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease,” said Dr. Patrick W. Serruys, Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study.
“The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodelling,” he added.
The results show that the overall MACE rate in the ABSORB trial was 3.3 per cent at six months; and the overall MACE rate at one year was 3.4 percent, adjusted for one patient who withdrew from follow-up.
Abbott’s bioabsorbable everolimus eluting stent also demonstrated 100 per cent procedural success and 94 per cent device success in the ABSORB trial.
“Patients and physicians like the idea of a stent that does its job and is then absorbed away,” said John A. Ormiston, cardiologist at Auckland City Hospital, in Auckland, New Zealand and principal investigator in the ABSORB trial.
“Abbott’s bioabsorbable stent has the potential to hold an artery open long enough for healing to occur, and we would expect an artery that is healed to function as it did before it became diseased,” he added.
Unlike a metallic stent, a bioabsorbable stent is designed to be slowly metabolised by the body and completely absorbed over time.
“Abbott’s bioabsorbable drug eluting stent system is a great example of scientific innovation leading to a breakthrough treatment for heart disease that has the potential to improve patients’ lives,” said Dr. John M. Capek, executive vice president of medical devices, Abbott.
“We look forward to continuing to evaluate the safety and effectiveness of our bioabsorbable stent platform in additional patients in the coming months,” he added. (ANI)
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