FDA Approves World’s First Fully Absorbable Vascular Scaffold for Coronary Artery Disease

Today, the U.S. FDA announced approval for the marketing of Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold System. According to Abbott’s product page, this is also the world’s first vascular scaffold that can be fully absorbed by the human body.

According to the World Health Organization, cardiovascular disease is the leading cause of death globally. In 2012, 17.5 million people died from cardiovascular diseases, with coronary heart disease accounting for 42% of these deaths. Coronary heart disease results from the accumulation of cholesterol-containing deposits in the coronary arteries. These deposits narrow the coronary arteries, thereby reducing blood flow to the heart. This can lead to chest pain, shortness of breath, fatigue, and other symptoms of heart disease.

Physicians frequently employ a procedure known as "angioplasty" to treat coronary artery disease. During this procedure, a metal stent is implanted into the patient’s coronary artery to prop open the vessel, thereby dilating the narrowed segment and maintaining unobstructed blood flow. However, these foreign-body metal stents may induce the accumulation of scar tissue in the surrounding area, potentially leading to restenosis of the vessel.

The launch of Absorb is expected to provide a definitive solution for patients worldwide requiring coronary angioplasty. The primary component of Absorb is poly-L-lactide, a material similar to those used in many other bioresorbable medical devices. Unlike permanent metallic stents, this material is absorbed by the body within three years, leaving behind only four platinum markers to indicate the implantation site. Additionally, Absorb releases everolimus, an immunosuppressant that prevents the formation of scar tissue. Collectively, these features effectively mitigate scarring caused by foreign bodies and maintain vessel patency, thereby preventing restenosis.

▲In clinical trials, the blood vessels remained patent after stent degradation.

In clinical trials, Absorb demonstrated favorable prognostic outcomes. “Both physicians and patients highly favor this stent,” said Dr. Gregg Stone of Columbia University Medical Center, the principal investigator of the clinical trial. “It is fully resorbed, leaving no residue behind. Its non-metallic structure allows the coronary arteries to pulsate and expand naturally. Furthermore, it reduces the risk of future vessel re-occlusion and facilitates the implementation of subsequent treatment options.”

“Abbott’s goal is to help people around the world live better, fuller, and healthier lives,” said Dr. Deepak Nath, Senior Vice President of Abbott’s Cardiovascular division. “The Absorb system treats coronary artery disease without requiring patients to have a permanent metallic stent implanted. This provides greater peace of mind and enables them to return more fully to their daily lives without concerns about metallic implants. We are very excited about the launch of the Absorb system.”

References:

[1] FDA approves first absorbable stent for coronary artery disease

[2] FDA APPROVES ABBOTT'S ABSORB™ BIORESORBABLE STENT, THE ONLY FULLY DISSOLVING HEART STENT

[3] Absorb: The World’s First Fully Bioresorbable Vascular Scaffold