TITLE: PERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF SERIAL, BALLOON-EXPANDABLE, PACLITAXEL-ELUTING RESORBABLE SCAFFOLDS (the Efemoral Device) 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 i s to conduct the first long-term, controlled, pre-clinical animal study using the device.
TITLE: PERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF SERIAL, BALLOON-EXPANDABLE, PACLITAXEL-ELUTING RESORBABLE SCAFFOLDS (the Efemoral Device) The pathological degeneration of arteries known as ?atherosclerosis? is responsible for one-third of all human mortality. It represents a tremendous current and future health burden accountable for >23 million projected annual deaths by the year 2030. Atherosclerosis involving lower extremity arteries, known as ?peripheral arterial occlusive disease? (PAOD), affects 74% of the population over 70 years old. Left untreated, symptomatic patients can sustain severe disability, limb loss and/or death. The standard-of-care for patients with symptomatic PAOD is percutaneous peripheral intervention (PPI) including the techniques of balloon angioplasty, drug-coated balloon angioplasty, percutaneous atherectomy, and bare and drug-eluting self-expanding stenting. Unfortunately, the effectiveness and durability of available devices is 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, serial, balloon-expandable, resorbable, paclitaxel- eluting scaffold designed to provide more immediately effective and durable endovascular treatment of symptomatic femoropopliteal occlusive disease. Unlike most peripheral intravascular devices that are simply adaptations and ?scale-ups? of coronary devices, the Efemoral scaffold system is specifically designed for the unique environment of the peripheral vasculature. Its design exploits known principles of vascular biology including that, (1) a rigid device that is deployed via balloon expansion represents the optimal design of an intravascular stent given its transient effect on the arterial wall and relative ease of precise implantation, (2) a long, rigid device cannot be safely implanted in an artery that bends and twists with skeletal motion, (3) long arteries that bend and twist could be effectively treated with multiple, short stents that allow the intervening, non-stented arterial segments to move unencumbered, (4) the length, number and spacing of the stent segments could be determined by the known bending characteristics of the target arteries, and (5) arteries need only be scaffolded transiently; late dissolution of the stent will have no effect on the effectiveness of treatment. This SBIR proposal describes the pre-clinical development of the Efemoral device; a serial, 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 animal study using this novel device. Efemoral Medical, Inc. was co-founded by a vascular surgeon and serial biotechnical entrepreneur with over fifty years of collective experience in vascular intervention, medical device development and early-stage start-up initiatives. The partnership and team brings a wealth of domain-specific knowledge and professional contacts for the application of new technologies for vascular disease. The company has already garnered private funding and made significant progress is reaching initial developmental milestones. This application seeks to extend these early observations through the conduct of a large scale, long-term, controlled pre-clinical study with the hypothesis that the vascular response to the Efemoral Device will be superior to the current standard-of-care.
