The world's first drug-eluting bioresorbable plastic vascular scaffold (BVS) is now widely available across Europe and parts of Asia Pacific and Latin America.
The Absorb BVS from Abbott (Abbott Park, IL) is described as a first-of-its-kind device for the treatment of coronary artery disease (CAD). Functionally, it is similar to metal stents. It restores blood flow to the heart, but then dissolves into the body.
|Stent inspection at Abbott.|
Abbott says that the treated coronary artery may resume more natural function and movement because it is free of a permanent metallic stent. It is made of polylactide, a naturally dissolvable material commonly used in medical implants such as dissolving sutures. Competing bioresorbable stents use other types of plastics.
"This innovation represents a true paradigm shift in how we treat coronary artery disease. With the launch of Absorb, a scaffold that disappears after doing its job is no longer a dream, but a reality," says Patrick W. Serruys, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "Patients are excited about Absorb since it may allow blood vessels to return to a more natural state and expand long-term diagnostic and treatment options."
The international launch of Absorb follows a medical trial program that encompasses five studies in more than 20 countries. Abbott says that study data indicate that Absorb performs similar to a best-in-class drug-eluting stent on tests such as major adverse cardiovascular events (MACE) and target lesion revascularization (TLR).
"Abbott has remained committed to meeting the growing physician and patient demand for a bioresorbable vascular scaffold--from the initial device developed nearly 10 years ago to the expansion of our manufacturing capabilities to support this international launch," says John M. Capek, executive vice president, Medical Devices, Abbott. "We are proud to be the first company to commercialize a drug-eluting bioresorbable vascular scaffold, which has the potential to revolutionize the way physicians treat their patients with coronary artery disease."
Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a stent, which is a permanent implant. The scaffold provides support to the vessel until the artery can stay open on its own, and then dissolves naturally. Abbott's BVS delivers a drug called everolimus to inhibit in-stent thickening in the coronary arteries.
Absorb is not yet approved for sale in the United States. It is authorized for sale in CE Mark countries: Europe, the Middle East, Hong Kong, Singapore, Malaysia, New Zealand, and parts of Latin America.