Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee

Abbott earned a groundbreaking FDA approval on Monday for its dissolving stent designed to unclog arteries below the knee. 

The device, called the Esprit BTK System, is meant to treat patients who have chronic limb-threatening ischemia below the knee. This condition is characterized by insufficient blood flow to the lower extremities, which leads to persistent pain, ulcers and tissue necrosis — with a significant risk of limb amputation if left untreated

Chronic limb-threatening ischemia below the knee may be the most severe form of peripheral artery disease, said Jennifer Jones-McMeans, divisional vice president of global clinical affairs at Abbott’s vascular business.

“This is really a landmark moment,” she said in an interview. “We’re looking at the first dissolving stent to treat below-the-knee arterial disease. And really, when you look at this severe form of upper artery disease, it’s considered kind of the terminal end of this disease — meaning that these patients have very limited options and their lifespan is going to be impacted.”

About 20 million people in the U.S. live with peripheral artery disease, and only about 10% of them are diagnosed with this severe form, Jones-McMeans noted.

Until Monday, the FDA had never approved a stent or drug-coated balloon to help arteries stay open below the knee. The common standard of care for patients with chronic limb-threatening ischemia typically involves endovascular interventions, such as angioplasty and stenting, to restore blood flow in the affected arteries.

Abbott developed a dissolvable device that keeps arteries open, as well as delivers a drug — Everolimus —  to support vessel healing. The device, which is made of a material similar to dissolvable stitches, is implanted using a catheter during a minimally invasive procedure.

Abbott’s device is designed to provide support for about three years. After that point, the artery should be able to remain open on its own  and the device dissolves, Jones-McMeans explained.

She added that by opening blood flow below the knee, the device can help wounds heal better, as well as prevent the development of new wounds. Patients face the “devastating risk” of amputation when a wound can’t heal properly, she pointed out.

“[The device] will be the first of its kind approved in the United States to treat this devastating condition — where currently, patients go in and have a plain balloon angioplasty that is extremely limiting, with which the patient is really kind of on a pathway to have retreatment after the treatment,” Jones-McMeans said.

Abbott’s newly approved device gives providers and patients a new tool that will keep patients healthier for longer, she declared.

Photo: Michael Burrell, Getty Images