Shots:

• The LIFE-BTK study is the first IDE trial in the US to evaluate a fully resorbable device for treating blocked arteries below the knees- or CLI- in people with advanced stages of PAD. The study will assess Esprit BTK resorbable scaffold in 225 patients across the globe
• The focus of the study is to evaluate the safety & efficacy of the device in CLI patients with up to two lesions in separate infrapopliteal vessels. Currently- there are no stents or drug-coated balloons approved for use below the knee in the US
• The Esprit BTK System consists of a thin strutted scaffold which measures 99 microns made from PLLA- a semi-crystalline bioresorbable polymer engineered to resist vessel recoil- providing a platform for drug delivery and has received the US FDA’s BDD- which streamlines the review and pre-market approval timelines

­ Ref: Abbott | Image: Abbott