Abbott has received the US Food and Drug Administration (FDA) approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System).
The Esprit BTK System is a breakthrough dissolving stent system intended for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
It comprises a similar material as dissolving sutures and is designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing before completely dissolving.
The stent system is implanted into the arteries during a minimally invasive procedure using a catheter, through a small incision in the leg.
Once the blockage is open, the Esprit BTK scaffold helps the vessel heal and provides support for around three years until it gains the strength to remain open.
Abbott vascular business senior vice president Julie Tyler said: “At Abbott, we’ve recognised the significant burden of disease and limited treatment options available for people living with the most severe form of PAD.
“That’s why we’re revolutionising treatments with resorbable scaffold technology below the knee. Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.”
CLTI is a serious form of peripheral arterial disease (PAD) that occurs when arteries become clogged with plaque, preventing blood flow and oxygen from reaching the lower leg and foot.
Currently, no stents or drug-coated balloons are approved in the US, for opening the arteries below the knee.
Balloon angioplasty is the standard of care, in which a small balloon is delivered through a catheter to compress the blockage and open the vessel to restore its blood flow.
However, balloon angioplasty alone is associated with poor short- and long-term results, and in many cases, the vessels get blocked again, said the medical device maker.
Abbott evaluated its Esprit BTK System in the LIFE-BTK trial, which showed that the stent system reduces disease progression and improves outcomes compared to balloon angioplasty.
LIFE-BTK trial principal investigator Sahil Parikh said: “The FDA approval of Abbott’s Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide.
“By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”
