International Coronary Artery Disease Patients Have Access To Abbott’s Absorb™ Bioresorbable Vascular Scaffold

In short

Abbott is trumpeting the international availability of Absorb™, the world’s first drug eluting bioresorbable vascular scaffold (BVS), which it says is now widely available across Europe and parts of Asia Pacific and Latin America.

Background

Heart disease is the leading cause of death for men and women around the world, and Coronary Artery Disease (CAD) specifically remains the most commonly encountered heart condition.

We’ve all heard of stents and indeed written extensively about their development over the past few years. Abbott would like us to see its new device as the logical successor to the metallic stent and the US company is ahead of the game, albeit not alone as evidenced by our own coverage of offerings from France and Japan in recent months.

Like its metal parents, Absorb works by restoring blood flow to the heart by opening and holding open the target coronary artery. Absorb is different however and a first-of-its-kind device by then dissolving into the body, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent. Absorb is made of polylactide, a naturally dissolvable material and the most commonly used polymer in medical implants such as dissolving sutures over the past forty years.

Abbott says the potential long-term benefits of a scaffold that dissolves are significant and include a return of vessel function, allowing it to expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising. It’s possible, indeed likely that the need for long-term treatment with anti-clotting medications may be reduced. Finally any future intervention would be unobstructed by a permanent implant.

Abbott’s Absorb BVS delivers everolimus, an anti-proliferative drug used in Abbott’s Xience coronary stent systems. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

Studies

The international launch of Absorb is supported by a robust clinical trial program that encompasses five studies in more than 20 countries around the world. Study data indicate that Absorb performs similar to a best-in-class drug eluting stent across traditional measures such as major adverse cardiovascular events (MACE) and target lesion revascularisation (TLR), while providing patients with the added benefits associated with a device that dissolves over time.

Physician comments

“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,” said Patrick W. Serruys, M.D., Ph.D., 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.”

Company comments

“Absorb is a leading example of Abbott’s dedication to advancing patient outcomes through innovative technology. 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,” said John M. Capek, executive vice president, Medical Devices, Abbott. “We are proud to be the first company to commercialise a drug eluting bioresorbable vascular scaffold, which has the potential to revolutionise the way physicians treat their patients with coronary artery disease.”

Regulatory status

Absorb is neither approved nor authorised for sale in the United States. Absorb is authorised for sale in CE Mark countries. Absorb is now available in Europe, the Middle East, parts of Asia Pacific, including Hong Kong, Singapore, Malaysia and New Zealand, and parts of Latin America.

Source: Abbott