PERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF SERIAL, BALLOON-EXPANDABLE, PACLITAXEL-ELUTING RESORBABLE SCAFFOLDS (the Efemoral Device)

Efemoral Medical, Inc., Lake Forest IL

Investigators

Linked publications & trials

Abstract

Peripheral Arterial Occlusive Disease (PAOD), also known as Peripheral Vascular Disease, ?poor circulation?, or ?hardening of the arteries? is a worldwide plague. Symptomatic PAOD affects approximately 10% of the population over the age of 50 and 20% of the population over the age of 70. Left untreated, it can lead to severe disability and extremity amputation. Limb loss in the aging American population has reached epidemic proportions; the annual cost of managing the approximately 1.7 million citizens currently living with extremity amputations has been estimated at $4.3 billion. Currently, the treatment-of-choice for restoring patency to stenotic or occluded arteries in symptomatic patients with PAOD is percutaneous balloon angioplasty followed by implantation of permanent metal stents. Unfortunately, their effectiveness remains limited as up to 50% of conventional endovascular procedures will be complicated by arterial restenosis and recurrence within the first year. This research proposal describes the development of novel, balloon-expandable, resorbable, paclitaxel-eluting scaffold designed to provide more effective and durable endovascular treatment of symptomatic PAOD. Its Specific Aim is to conduct the first long-term, controlled, pre-clinical animal study using the device.