The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving.
Abbott says that before this approval, there were no stents or drug-coated balloons to treat below-the-knee chronic limb-threatening ischemia in the U.S.
The current standard of care, balloon angioplasty, relies on a small balloon delivered via a catheter. It compresses against the arterial wall, opening the blood vessel and restoring flow.
However, Abbott said blockages treated only with this method have poor short- and long-term results. Many cases result in the vessels becoming blocked again, requiring additional treatment.
The Espirit BTK system, a first-of-its-kind dissolvable stent, features a material similar to dissolving sutures. Implanted in a catheter-based, minimally invasive procedure, it goes through a small incision in the leg. Once it opens the blockage, the scaffold helps to heal the vessel and provides support for approximately three years. At that point, the company says the vessel is strong enough to remain open on its own.
Last October, Abbott shared data from its LIFE-BTK trial, which met both its primary safety and effectiveness endpoints. The study demonstrated a reduction in disease progression and improved medical outcomes compared to balloon angioplasty.
“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, SVP 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.”
The analysts’ view on the Abbott regulatory win
BTIG analysts Marie Thibault and Sam Eiber wrote that FDA approval for Espirit came in earlier than expected. They previously forecast approval in the second half of 2024.
The analysts say they still await details on launch timing but expect a slower rollout for the system.
“We expect it will be gradual since it is important for centers to be well-trained and for operators to prepare the vessel properly in order to replicate the trial’s excellent clinical results,” the analysts wrote. “Over time, we expect Esprit could enjoy consistent use given the difficult-to-treat patient population and limited effective alternative treatment options.”
The analysts estimate that the U.S. market consists of about 230,000 BTK procedures and could see that expanding with good treatment options. They said Abbott estimates that it has a 29% market share in the U.S. BTK market. The company expects to continue to keep accelerating growth on that front.
Thibault and Eiber maintained their “Buy” rating for Abbott.
