Abbott has initiated Absorb BTK clinical trial to treat below-the-knee (BTK) critical limb ischemia.
The device is made of polylactide, a biocompatible material which restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves.
The multi-center, prospective, single-arm study is designed to assess the safety and efficacy of the the Absorb bioresorbable vascular scaffold (BVS) 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.
Absorb BTK trial principal investigator and University of Leipzig Medicine professor Dierk Scheinert said they will test whether this approach restores blood flow with a temporary scaffold – has the potential to improve the outcomes of patients with critical limb ischemia.
Abbott Vascular chief medical officer and Medical Affairs divisional vice president Charles Simonton said their efforts to apply this technology to the treatment of vascular diseases beyond coronary artery disease underscore their commitment to develop new products to improve vascular care for patients.