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

cath lab, radiation exposure, glocoma
Feature | Radiation Dose Management| May 26, 2016 | Dave Fornell
May 27, 2016 — Radiation exposure to cath lab staff and physicians has seen growing concern in recent years, as the p
Edwards, Sapien 3, SOURCE 3 Registry, EuroPCR 2016
News | Heart Valve Technology| May 24, 2016
Thirty-day data from the European post-approval study of the Edwards Sapien 3 transcatheter aortic heart valve...
News | Cath Lab| May 24, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions took place May 4-7, 2016
HeartFlow, FFR-CT, ruptured coronary plaques, EMERALD study, EuroPCR 2016
News | CT Angiography (CTA)| May 23, 2016
First-in-human data presented at EuroPCR 2016 demonstrate that hemodynamic data from HeartFlow Inc. may help predict...
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016
News | Heart Valve Technology| May 20, 2016
Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR...
Bioventrix, Revivent-TC System, heart failure, first-in-man procedure
News | Heart Failure| May 19, 2016
BioVentrix announced the first-in-man use of its next-generation Revivent-TC System with an endovascular catheter-based...
St. Jude Medical, EuroPCR 2016 studies, FFR, LAAO, left atrial appendage occlusion, fractional flow reserve, Amplatzer
News | Cath Lab| May 19, 2016
St. Jude Medical Inc. announced results from two cardiovascular clinical trials presented at EuroPCR 2016.
bioabsorbable vascular graft, children, feasibility study, Bakoulev Center Moscow, AATS 2016 meeting

Image courtesy of Bakoulev Scientific Center for Cardiovascular Surgery

News | Stent Grafts| May 18, 2016
Bioabsorbable heart valves or blood vessels are designed to harness the body’s innate healing process, enabling the...
RDAVR, aortic valve replacement, Edwards Intuity, TRANSFORM Trial, AATS meeting
News | Heart Valve Technology| May 18, 2016
The TRANSFORM trial was designed to evaluate the safety and performance of an investigational rapid deployment aortic...
Overlay Init