Feature | April 06, 2011

Bioresorbable Stent Demonstrates Positive One-Year Results

April 6, 2011 – The second phase of a trial evaluating the world’s first drug-eluting bioresorbable vascular scaffold (BVS) showed positive one-year results. Data from the ABSORB Trial, which looked at Abbott’s BVS, were presented at the American College of Cardiology's (ACC) Scientific Session in New Orleans.

At one year, the device demonstrated a 6.9 percent rate of major adverse cardiac events (MACE) and no reports of blood clots (thromboses). In an analysis of 56 of the 101 patients, imaging results showed a late loss of 0.27 mm, which is comparable to past data on drug eluting stents. Importantly, of the patients' vessels that were assessed for vasomotor function, nearly all showed signs of vasomotion (constriction or dilation of the vessel) at one year. This indicates that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold, which had begun to be metabolized.

"The one-year data in these patients confirm earlier results seen at the six- and nine-month periods - that the ABSORB device has the potential to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way not possible with permanent metallic implants," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "In addition, the one-year late loss seen with ABSORB is similar to what has been seen in a historical series of drug eluting stents, which is an encouraging indication that a bioresorbable scaffold like ABSORB might be able to offer the performance capabilities of a metallic drug eluting stent but with the added benefit of eventually dissolving away."

The device is made of polylactide, a biocompatible material that is commonly used in medical implants such as dissolvable sutures. The device is designed to slowly metabolize and eventually be resorbed by the body after providing support to the vessel during the healing process. It received CE mark in Europe earlier this year and is not approved or available for sale in the United States.

Since a permanent metallic implant is not left behind, a patient's vessel may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes it a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research will show whether the need to administer long-term dual anti-platelet therapy to patients is necessary once the temporary scaffold is metabolized.

"The positive one-year clinical results from the ABSORB trial provide support for the clinical performance of the device and its potential to change the way coronary artery disease is treated," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "Abbott is committed to continuing to build the body of clinical evidence supporting this novel therapy, and we are planning additional clinical trials this year."

For more information: www.abbott.com

Related Content

News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
warfarin, long-term stability, atrial fibrillation, DCRI study, Sean Pokorney
News | Antiplatelet and Anticoagulation Therapies| August 16, 2016
August 16, 2016 — Warfarin prescribed to prevent strokes in...
Cardiovascular Systems Inc., LIBERTY 360 study, Amputation Prevention Symposium, PAD, peripheral artery disease, atherectomy
News | Peripheral Arterial Disease (PAD)| August 16, 2016
August 16, 2016 — Cardiovascular Systems Inc.
Blood flow fluid dynamics, impact of sheer stresses in blood vessels

An example of blood flow fluid dynamics showing sheer stresses on the vessel wall. Image courtesy of the British Heart Foundation. It is beleived sheer stress and fluid dynamics inside vessles play a role in vascular disease.

News | Cardiac Diagnostics| August 16, 2016
August 16, 2016 — New research from a fluid mechanics team in Greece reveals how blood flow dynamics within blood ves
regular exercise, heart enlargement, heart disease misdiagnosis, MRC Clinical Sciences Centre study

People who exercise regularly may develop hearts that are larger (right), with thicker muscle and bigger chambers, than those who are more sedentary (left). Image courtesy of MRC Clinical Sciences Centre.

News | Cardiac Diagnostics| August 10, 2016
Scientists have shown that people who exercise for even a few hours each week can enlarge their hearts. This is a...
Absorb, bioresorbable stent, FDA approval, FDA approves, FDA clears, most popular content, most popular stories, DAIC

The FDA clearance of the first bioresorbable stent, the Abbott Absorb, the first week of July has been the most popular story so far for all of 2016. It is the first fully dissolving stent approved for the U.S. market and many experts say this technology could be a paradigm shift in coronary and peripheral therapies in the coming years as the technology improves. 

Feature | August 05, 2016 | Dave Fornell
 
Overlay Init