News | October 25, 2006

Initial Results Reported from Fully Bioabsorbable Drug-Euting Coronary Stent Trial

Early clinical results from Abbott's ongoing ABSORB clinical trial, the world's first study to evaluate the safety and performance of a fully bioabsorbable drug-eluting stent platform for the treatment of coronary artery disease in humans, were presented during the 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. Initial results for the first 30 patients in the trial demonstrated no MACE (Major Adverse Cardiac Events, such as heart attack) and no stent thrombosis at 30 days for patients who received a bioabsorbable everolimus-eluting stent.

Abbott's bioabsorbable drug-eluting stent is made of polylactic acid, which is designed to be fully absorbed and slowly metabolized by the coronary artery. The everolimus-coated stent will release the drug into the artery and then slowly absorb over time. The goal is to leave a healed natural vessel behind.

"We are highly encouraged by these initial results from the ABSORB trial," said John Ormiston, M.D., Auckland City Hospital, New Zealand, and co-principal investigator of the study. "We are eager to explore Abbott's bioabsorbable technology as a potential clinical option for the treatment of coronary artery disease."

The ABSORB trial is designed to assess safety and performance of Abbott's bioabsorbable everolimus-eluting stent in the treatment of patients with single de novo, native coronary artery disease or untreated lesions. Everolimus has been shown to reduce tissue growth in the coronary vessels following stent implantation.

"Bioabsorbable technology holds great potential for many vascular applications," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. "We intend to use the data from the ABSORB trial to study and develop therapies that can better serve physicians and their patient. Abbott's support of this study further demonstrates the depth of our vascular pipeline and illustrates our commitment to investing in future technologies."

The ABSORB trial is a prospective, non-randomized (open label) study and has been designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. The key endpoints of the study include an assessment of the safety (MACE and stent thrombosis rate) at 30, 180, and 270 days, with an annual follow-up for up to five years, and successful deployment of the bioabsorbable drug-eluting stent. Additional endpoints of the study include angiography and intravascular ultrasound (IVUS) follow-up at 180 days and two years.

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
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...
Overlay Init