(RTTNews) -
Drug maker Abbott Laboratories (ABT:
News ), said Monday its fully bioabsorbable drug eluting coronary stent in the first phase of its Absorb trial successfully treated coronary artery disease and was absorbed into the walls of treated arteries. The results from the company's three year data from the first phase included 30 patients.
Abbott said patients in the trial did not experience any blood clots or stent thrombosis during the trial duration and there were no new major adverse cardiac events between six months and three years of the trial.
Commenting on the trial results Patrick Serruys, Professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the Absorb trial said, "Abbott's bioabsorbable stent has the potential to be a major breakthrough for coronary artery disease patients. The data show that patients continue to do well three years after treatment with the bioabsorbable coronary stent."
"The strong results confirm my belief that bioabsorbable technology is the next revolution in interventional cardiology," Serruys added.
Abbott's bioabsorbable drug eluting coronary stent is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures designed to restore blood flow by propping open a clogged vessel, and to provide support until the blood vessel heals.
Bioabsorbable stent, unlike metallic stent is designed to be slowly metabolized by the body and is completely absorbed over time.
Abbott claims to be the only company with three-year clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent.
The Absorb trial is a prospective, non-randomized or open label, two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland.
The company has completed patient additional 101 patients enrollment from 12 centers in Europe, Australia and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support.
Abbott said it was initiating Absorb Extend trial to evaluate the performance of its proprietary fully bioabsorbable stent technology. Absorb Extend trial is slated to begin enrolling before the end of the year.
Charles Simonton, Divisional Vice President, Medical Affairs, and chief medical officer, Abbott Vascular said, "The second phase of the ABSORB trial enrolled very quickly, which is a testament to the excitement among the clinical community around the potential shown with this technology. We look forward to starting the ABSORB EXTEND trial to further evaluate promising attributes of our fully bioabsorbable technology in a broader patient population."
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