First-Of-Its-Kind Dissolvable Stent to Improve Outcomes for Patients with Severe PAD

Peripheral artery disease (PAD) affects millions and presents serious health risks, particularly its severe form, chronic limb-threatening ischemia (CLTI). CLTI develops when arteries are blocked by plaque, significantly reducing blood and oxygen flow to the lower leg and foot. This condition can cause severe pain, and non-healing wounds, and may lead to amputation. CLTI's five-year survival rates are alarmingly lower than those for many major cancers, including breast, colorectal, and prostate cancer.

Traditionally, treatments for CLTI below-the-knee (BTK) have been limited. In the U.S., no stents or drug-coated balloons have been approved for this use, leaving balloon angioplasty as the standard of care. This method involves a small balloon delivered by a catheter to the blockage, compressing it against the arterial wall to open the vessel and restore blood flow. However, this treatment often has poor outcomes both in the short and long term, with many patients experiencing re-blockage and requiring further procedures.

Image: The Esprit BTK System has received FDA approval for arteries below the knee (Photo courtesy of Abbott)

The Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System) from Abbott (Abbott Park, IL, USA) is a first-of-its-kind dissolvable stent that is made of similar material used in dissolving sutures. The device is implanted during a minimally invasive procedure through a small incision in the leg. It serves to keep the artery open and deliver a drug that aids vessel healing, all before fully dissolving. This scaffold supports the vessel for about three years until it is capable of staying open independently.

The LIFE-BTK trial, which evaluated Abbott's Esprit BTK System, demonstrated that the Esprit BTK System improves medical outcomes and slows disease progression compared to the traditional balloon angioplasty. With the recent approval from the U.S. Food and Drug Administration (FDA), the Esprit BTK System now provides a new, viable treatment option for the over 20 million Americans suffering from PAD, marking a significant advancement in medical care for those with this challenging condition.

"At Abbott, we've recognized 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 revolutionizing treatments with resorbable scaffold technology below the knee," said Julie Tyler, senior vice president of Abbott's vascular business. "Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives."