ABSORB Clinical Trial Begins for Treatment of Below-the-Knee Critical Limb Ischemia
September 8, 2011 – Abbott announced the initiation of ABSORB BTK, an international clinical trial evaluating the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) for the treatment of below-the-knee (BTK) critical limb ischemia. Critical limb ischemia, a severe form of peripheral artery disease (PAD), occurs when blocked vessels impair blood flow to the lower extremities, which can eventually lead to limb amputation. Absorb restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves within approximately two years. The first patient was enrolled into the ABSORB BTK trial by Marc Bosiers, M.D., head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium.
"Patients with critical limb ischemia often progress to where they have few options beyond limb amputation, so there is a tremendous need for new therapies to prevent this outcome," said Dierk Scheinert, M.D., professor of medicine, the University of Leipzig, Germany, and principal investigator of the ABSORB BTK trial. "The Absorb device represents the next generation in revascularization therapies that may hold promise for patients with vessel disease in the lower leg. With the ABSORB BTK trial, we 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."
The Absorb device is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Because a permanent metallic implant is not left behind, naturally occurring vessel functions may be restored, which is one of the features that make this device a significant innovation. In January 2011, Abbott announced that ABSORB received CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. Absorb currently is under development and is not available for sale in the United States.
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.
About Critical Limb Ischemia
Critical limb ischemia is a severe form of peripheral artery disease (PAD) that is characterized by chronic pain, even at rest, as well as ulcers and gangrene (tissue death) that develop as a result of chronically poor blood flow to the lower limbs. Endovascular treatments of below-the-knee arteries, including balloon angioplasty and stenting, have emerged as effective forms of therapy. For some patients, surgical bypass procedures are performed. If left untreated, the disease can eventually lead to amputation and limb loss.
For more information: www.abbott.com