The US Food and Drug Administration has officially given its approval to Abbott’s Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), which is a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK), a condition that falls under the umbrella of PAD. In case you weren’t aware, PAD is a highly-prevalent medical disease, with more than 20 million in the US understood to be suffering from it at the moment. However, despite such a big projection, only 10% of these people have actually received a formal diagnosis. Coming back to CLTI, it happens to be a serious form of PAD that occurs when arteries become clogged with plaque, thus preventing blood flow and oxygen from reaching the lower leg and foot. Hence, people supposedly living with CLTI often experience extreme pain, open wounds that don’t heal, and in some severe cases, may even have to resort to amputation. Making matters worse is a piece of data where it is revealed that over a five-year period, CLTI has a lower survival rate than breast, colorectal, and prostate cancer combined. But how will Abbott’s latest brainchild solve this problem? Well, the answer resides in its ability to keep arteries open and deliver a drug called Everolimus. By doing so, it supports vessel healing prior to completely dissolving within the body.
“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,” said Sahil A. Parikh, M.D., Columbia University Irving Medical Center, and one of the principal investigators of the LIFE-BTK trial. “By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”
Talk about the stated device on a slightly deeper level, Esprit BTK System is a first-of-its-kind dissolvable stent made from material similar to dissolving sutures. In practice, you basically implant it during a catheter-based minimally invasive procedure via a small incision in the leg. Once that bit is duly completed, Esprit BTK scaffold gets down to healing the vessel, delivering support for approximately three years until the vessel is strong enough to remain open on its own. The FDA approval for this device came after a LIFE-BTK trial, where it was discovered that Esprit BTK System reduces disease progression, and at the same time, helps improve medical outcomes compared to balloon angioplasty, the current standard of care. More on the latter bit would reveal how, considering US hasn’t had any stents or drug-coated balloons approved for use below the knee, balloon angioplasty has been the go-to alternative for care. This method involves delivering a small balloon through a catheter to the blockage to compress it against the arterial wall, thus opening the vessel and restoring blood flow. However, the problem here is that blockages treated only with balloon angioplasty have poor short- and long-term results. In fact, across many cases, vessels have shown to become blocked again, and therefore, require more treatment.
“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.”