Abbott's Absorbable Esprit BTK Stent Receives Approval in Canada for CLTI Treatment

Oct 06, 2025 10:02 CST Updated 10:02

Abbott

Diagnostic and pharmaceutical product manufacturers

Abbott Announces Its Bioresorbable ScaffoldEsprit BTKObtainApproved for marketing by Health Canada。Esprit BTKIt is a product specifically designed for patients with chronic limb-threatening ischemia (CLTI) below the knee, which keeps arteries open and releases the drug everolimus to promote...Into the blood vessel healing, and ultimately completely degrades after completing its mission. Before this,Esprit BTKApproved for marketing by the FDA and CE.

Expert Evaluation

"Health Canada's approval of Abbott's Esprit BTK represents a significant milestone in our journey to combat below-the-knee peripheral artery disease and ushers in a new era of improved clinical outcomes for patients worldwide. By offering a treatment option superior to balloon angioplasty, Abbott is reshaping the therapeutic landscape for CLTI."

---Brian DeRubertis New York Presbyterian-Weill Cornell Medical Center

Executive Evaluation

"We deeply understand that patients with severe PAD not only endure immense suffering from the disease but also face limited treatment options—existing solutions are often caught between high-risk surgeries and minimally invasive therapies with limitations. Our revolutionary bioresorbable stent technology for below-the-knee applications is filling this clinical gap, ultimately helping PAD patients regain a higher quality and more complete life."

---Julie Tyler Senior Vice President of Abbott's Vascular Business

Although peripheral artery disease (PAD) affects a large number of people, public awareness is severely lacking. Currently, more than 800,000 patients in Canada suffer from this condition, but only a small fraction have received a definitive diagnosis. Critical limb-threatening ischemia (CLTI), the most severe clinical manifestation of PAD, results from the buildup of arterial plaque that obstructs the delivery of blood and oxygen to the lower legs and feet. Patients often endure excruciating pain and suffer from non-healing open wounds. Approximately one in five CLTI patients ultimately require amputation, and over 50% of those undergoing amputation have never had a vascular assessment prior to the procedure. Moreover, 60% of amputees face a risk of death within five years post-surgery.

InEsprit BTKBefore its approval for marketing, the clinical standard treatment was balloon angioplasty—a technique that uses a catheter to deliver a tiny balloon to the site of the blockage, compressing the plaque against the arterial wall to restore blood flow.Flow. However, the short-term and long-term outcomes of treating vascular occlusion with balloon angioplasty alone are not ideal, and in most cases, restenosis occurs, leading to the need for repeated treatments.

Last year, Abbott announced clinical data showingEsprit BTK is significantly superior toBalloon Angioplasty.Esprit BTKNot only can it significantly improve patient outcomes, but it also reduces the need for repeat surgeries by 48% during the study period.

Esprit BTK

Esprit BTKIt is a product developed based on the technology of the previous generation of absorbable coronary stents --- Absorb BVS.Esprit BTKIncluding absorbable stents and delivery systems, its core technology – the absorbable stent – is made from poly-L-lactic acid (PLLA). PLLA is a semi-crystalline bioabsorbable polymer that can resist vascular recoil and provide a platform for drug delivery. The stent wall thickness is only 99μm, and the surface of the stent is uniformly coated with poly-D,L-lactic acid (PDLLA) and the cytostatic drug everolimus. PDLLA is an amorphous bioabsorbable polymer coating used for controlled drug release. Everolimus is a drug that inhibits cell proliferation, which can reduce the occurrence at the affected site.The growth of endothelial tissue, preventing vascular occlusion.

Esprit BTK can provide approximately three years of support in the blood vessel until the vessel is strong enough to remain open on its own.

The absorbable stent has two platinum markers at the distal and proximal ends, respectively, for precise positioning.

Abbott

Abbott, as a global leader in the healthcare industry, helps people live better at all stages of life. We bring cutting-edge technology to health and wellness, with leading products spanning diagnostics, medical devices, nutrition, and pharmaceuticals. Abbott's 109,000 employees worldwide empower people in more than 160 countries and regions to live life to the fullest.