The ABSORB bioresorbable vascular scaffold (BVS) from Abbott will be tested in an international clinical trial to treat below-the-knee (BTK) critical limb ischemia that results from a severe form of peripheral artery disease. The ABSORB, which was the subject of a promising Phase 2 clinical trial last year, is made of polylactide, a material used in a variety of medical products including some dissolvable sutures.
The principal investigator of the ABSORB BTK trial, Dierk Scheinert, M.D., stresses that patients with critical limb ischemia have few treatment options other than amputation. “[W]e will test whether this novel approach – restoring blood flow with a temporary scaffold – has the potential to improve the outcomes of patients with critical limb ischemia,” he explained.
As the press release explains:
ABSORB BTK is a prospective, single-arm, multi-center trial designed to evaluate the safety and efficacy of the ABSORB device in up to 90 patients with below-the-knee critical limb ischemia at up to 10 clinical trial sites in Europe and New Zealand. The primary endpoint is a composite of freedom from major adverse limb events (major amputation or major re-interventions) within one year or death within 30 days of the procedure.
After the device is implanted and restores blood flow to a blocked vessel, it will dissolve in roughly two years. After it dissolves, vessel function may return to normal.
In January of this year, the ABSORB received the CE Mark and was permitted to be sold in Europe to treat coronary artery disease.
Flashbacks: Abbott Gets EU OK for World’s First Bioresorbable Drug Eluting Stent; Abbott’s Bioresorbable Stent Continues to Prove Itself in Trials; Abbott’s Bioabsorbable Stent Showing Promise at Three Years