Press Release

Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial

AbbottPosted on:17 Nov 09
Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial- New ABSORB EXTEND Trial to Study Performance of Revolutionary Bioabsorbable Device in Approximately 1,000 PatientsPR NewswireORLANDO, Florida, November 16

ORLANDO, Florida, November 16 /PRNewswire/ -- Abbott (NYSE: ABT) today announced three-year data from the first 30patients in the first phase of the ABSORB clinical trial, demonstrating thatits fully bioabsorbable drug eluting coronary stent successfully treatedcoronary artery disease and was absorbed into the walls of treated arteries.Patients in this first phase of the ABSORB trial experienced no stentthrombosis (blood clots) out to three years and no new major adverse cardiacevents (MACE(1)) between six months and three years (3.6 percent at threeyears). These results were presented at the 2009 American Heart Association'sScientific Sessions.

To build upon the promising results of the ABSORB trial, Abbott isinitiating a large-scale trial called ABSORB EXTEND, which will enrollapproximately 1,000 patients from up to 100 centers in Europe, Asia Pacific,Canada and Latin America. ABSORB EXTEND is a single-arm study designed tofurther evaluate the performance of Abbott's proprietary fully bioabsorbablestent technology. The study will enroll patients with more complex coronaryartery disease and is slated to begin enrolling before the end of the year.

"Abbott's bioabsorbable stent has the potential to be a majorbreakthrough for coronary artery disease patients. The data show thatpatients continue to do well three years after treatment with thebioabsorbable coronary stent," said Patrick W. Serruys, M.D., Ph.D.,professor of interventional cardiology at the Thoraxcentre, ErasmusUniversity Hospital, Rotterdam, the Netherlands, and principal investigatorfor the ABSORB trial. "The strong results confirm my belief thatbioabsorbable technology is the next revolution in interventionalcardiology."

Abbott also announced that patient enrollment is complete for the secondphase of the ABSORB trial. The second phase of the ABSORB clinical trialenrolled 101 additional patients from 12 centers in Europe, Australia and NewZealand, and incorporated device enhancements designed to improvedeliverability and vessel support.

Abbott is the only company with three-year clinical data evaluating thesafety and performance of a fully bioabsorbable drug eluting coronary stent.Abbott's bioabsorbable everolimus eluting coronary scaffold is made ofpolylactide, a proven biocompatible material that is commonly used in medicalimplants such as absorbable sutures. As with a metallic coronary stent,Abbott's bioabsorbable technology is designed to restore blood flow bypropping open a clogged vessel, and to provide support until the blood vesselheals. Unlike a metallic stent, however, a bioabsorbable scaffold is designedto be slowly metabolized by the body and is completely absorbed over time.

"Abbott continues to make advancements with its promising bioabsorbabletechnology," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vicepresident, Medical Affairs, and chief medical officer, Abbott Vascular. "Thesecond phase of the ABSORB trial enrolled very quickly, which is a testamentto the excitement among the clinical community around the potential shownwith this technology. We look forward to starting the ABSORB EXTEND trial tofurther evaluate promising attributes of our fully bioabsorbable technologyin a broader patient population."

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phasestudy designed to enroll approximately 130 patients from Australia, Belgium,Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Keyendpoints of the study include assessments of safety - MACE and stentthrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years,with additional annual clinical follow-up for up to five years, as well as anassessment of the acute performance of the bioabsorbable drug eluting stent,including successful deployment of the system. Other key endpoints of thestudy include imaging assessments by angiography, intravascular ultrasound(IVUS), optical coherence tomography (OCT), and other state-of-the-artinvasive and non-invasive imaging modalities at six months, one year and twoyears.

Abbott's bioabsorbable drug eluting coronary device delivers everolimus,a drug that inhibits tissue proliferation. Everolimus, developed by NovartisPharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensedto Abbott by Novartis for use on its drug eluting stents. Everolimus has beenshown to inhibit in-stent neointimal growth in the coronary vessels followingstent implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leadingvascular care businesses. Abbott Vascular is uniquely focused on advancingthe treatment of vascular disease and improving patient care by combining thelatest medical device innovations with world-class pharmaceuticals, investingin research and development, and advancing medicine through training andeducation. Headquartered in Northern California, Abbott Vascular offers acomprehensive portfolio of vessel closure, endovascular and coronaryproducts.

About Abbott

Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs more than 72,000 people and markets its products in more than130 countries.

Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.

1. MACE is a composite measure of key efficacy and safety endpoints andincludes cardiac death, heart attack (myocardial infarction) andischemia-driven target lesion revascularization.

PR Newswire
http://www.prnewswire.co.uk/

Comments

Loading Comments Engine...
Advertising