News | November 17, 2009

New ABSORB EXTEND Trial Studies Bioabsorbable Stent in 1,000 Patients

Abbott's BVS bioabsorbable stent.

November 17, 2009 – Following positive three-year data from the first 30 patients treated with a fully bioabsorbable drug-eluting coronary stent, Abbott is initiating a large-scale trial with about 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America.

The ABSORB trial demonstrate the stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries. Patients in this first phase of the trial experienced no stent thrombosis out to three years, and no new major adverse cardiac events (MACE) between six months and three years (3.6 percent at three years). These results were presented Monday at the 2009 American Heart Association’s Scientific Sessions in Orlando.

Abbott also said yesterday it will soon begin the ABSORB EXTEND trial, a single-arm study designed to further evaluate the performance of Abbott’s fully bioabsorbable stent technology. The study will enroll patients with more complex coronary artery disease and is slated to begin enrolling before the end of the year.

“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,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “The strong results confirm my belief that bioabsorbable technology is the next revolution in interventional cardiology.”

The company also announced patient enrollment is complete for the second phase of the ABSORB trial. The second phase enrolled 101 additional patients from 12 centers in Europe, Australia and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support.

The bioabsorbable everolimus-eluting coronary scaffold is made of polylactide, a biocompatible material commonly used in medical implants such as absorbable sutures. Unlike a metallic stent, the scaffold is designed to be slowly metabolized by the body and is completely absorbed over time.

For more information: www.abbott.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init