Feature | April 16, 2014

Abbott Completes Enrollment of Absorb Trials in United States, Japan and China

April 16, 2014 — Abbott announced it has completed enrollment of three clinical trials to support approvals of the company's Absorb bioresorbable vascular scaffold (BVS) in the United States, Japan and China. Combined, the U.S., Japan and China account for more than 50 percent of the world's heart stent market. Absorb received CE mark in 2011 and is available in more than 60 countries around the world. 

"The randomized clinical trials for Absorb demonstrate Abbott's commitment to provide the highest level of clinical evidence possible to assess Absorb compared to metallic drug-eluting stents, the current standard of care," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "We look forward to evaluating the results of these trials, which we intend to submit to support regulatory approvals of the device." 

Absorb works by opening a blocked vessel and restoring blood flow to the heart similar to a metallic stent; however, unlike a metallic stent, Absorb dissolves over time, potentially leaving behind a more flexible vessel because it is free from a permanent metallic stent which cages the vessel. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

The ABSORB III clinical trial, which enrolled approximately 2,000 people in the United States, will evaluate the potential benefits of Absorb in people with coronary artery disease, a narrowing of one or more arteries that supply blood to the heart. The primary endpoint of ABSORB III is target lesion failure (TLF), a combined measure of the safety and effectiveness of Absorb in comparison to the company's Xience family of drug-eluting stents at one year.

"The rapid completion of enrollment in the Absorb randomized trials is a testament to the interest among doctors and patients in advancing new options to treat heart disease," said Gregg Stone, M.D., FACC, FSCAI, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital. "Absorb represents an entirely new approach to helping people with heart disease by doing the job of a metallic stent, but then disappearing after its work is done, giving people the opportunity to live their lives free of a permanent metallic device implanted in their arteries."

The ABSORB Japan and ABSORB China trials enrolled approximately 400 people each, and the primary endpoint is TLF at one year and late loss at one year, respectively, in comparison to the Xience family of drug-eluting stents.  The ABSORB II trial enrolled approximately 500 people, mostly in Europe, and one-year clinical results are anticipated later this year.  

"The medical community eagerly awaits the results of the randomized trials for Absorb," said Dean Kereiakes, M.D., FACC, FSCAI, medical director of the Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati, and professor of clinical medicine at Ohio State University. "We have made tremendous progress in interventional cardiology with the advances in metallic stents. A device that could provide similar benefits but not leave behind a permanent implant has the potential to transform the way coronary artery disease is treated."

For more information: www.abbott.com

Related Content

medical imaging, low-dose radiation, cancer, LNT model study
News | Radiation Dose Management| February 04, 2016
The widespread belief that radiation from X rays, CT scans and other medical imaging can cause cancer is based on an...
caffeine consumption, extra heartbeats, UCSF study, UC San Francisco, Journal of the American Heart Association
News | EP Lab| February 04, 2016
Contrary to current clinical belief, regular caffeine consumption does not lead to extra heartbeats, which, while...
sleep apnea, heart failure readmissions, Thomas Jefferson University study
News | Heart Failure| February 04, 2016
Early diagnosis and treatment of sleep apnea may reduce six-month readmissions for patients hospitalized with heart...
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
News | Heart Failure| February 04, 2016
New research from scientists at Sanford Burnham Prebys Medical Discovery Institute (SBP) published in the journal...
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Medtronic, CE Mark, Resolute Onyx DES, drug-eluting stent, expanded sizes and indications
News | Stents Drug Eluting| February 02, 2016
Medtronic plc announced the recent CE Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES,...
Allegheny General Hospital, MRI, patients with implantable cardiac devices, safety and effectiveness
News | EP Lab| February 01, 2016
The findings of a major study led by cardiovascular imaging specialists at Allegheny General Hospital (AGH) suggest...
News | EP Lab| January 29, 2016
Diseased hearts may be thrown out of rhythm by structural differences, now visible for the first time, in protein...
TOBA-BTK study, six-month results, LINC 2016, Tack Endovascular System
News | Peripheral Arterial Disease (PAD)| January 29, 2016
Intact Vascular Inc. announced that positive six-month results from its Tack Optimized Balloon Angioplasty – Below-the-...
Overlay Init