Abbott has delivered new, longer-term data from a clinical study of its dissolving stent for severe peripheral artery disease located below the knee, following the implant’s approval by the FDA earlier this year.
In patients with chronic limb-threatening ischemia, or CLTI, the Esprit BTK drug-eluting scaffold was able to cut the number of repeat vascularization procedures by about half through a period of two years—or 48%, compared to people who underwent standard balloon angioplasty.
The findings from the company’s randomized LIFE-BTK trial evaluated more than 260 people at risk of amputation and were presented as a late-breaking study at the VIVA conference in Las Vegas. One-year data were previously spotlighted at 2023’s TCT meeting, where Esprit BTK showed it could reduce the rate of the treated blood vessel re-narrowing by about 25%.
At the two-year timepoint, that improvement increased to about 35%; according to Abbott, 90% of Esprit BTK patients did not require a reintervention after 24 months, while about 61% were free from CLTI symptoms compared to 33% in the control arm.
The scaffold is made of a naturally dissolving material that is absorbed by the body over a period of about three years, similar to certain sutures. It also releases a dose of the immunosuppressant everolimus, similar to Abbott’s metal drug-laden stents.
The FDA gave Esprit BTK a green light this past April—delivering a new treatment option for below-the-knee patients, as there have been no other approvals of stents or drug-coated balloons for the lower legs’ small, twisting arteries.
However, earlier this week the agency gave the go-ahead for R3 Vascular to conduct a human clinical trial of its Magnitude sirolimus-eluting, bioresorbable scaffold. That Silicon Valley startup raised $87 million this past May in venture capital funding to deliver a potential competitor in the space.