Efemoral Medical, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Project Summary Abstract TITLEPERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF SERIALBALLOON EXPANDABLEPACLITAXEL ELUTING RESORBABLE SCAFFOLDSthe Efemoral DeviceAbstract Peripheral Arterial Occlusive DiseasePAODalso known as Peripheral Vascular Diseasepoor circulationorhardening of the arteriesis a worldwide plagueSymptomatic PAOD affects approximatelyof the population over the age ofandof the population over the age ofLeft untreatedit can lead to severe disability and extremity amputationLimb loss in the aging American population has reached epidemic proportionsthe annual cost of managing the approximatelymillion citizens currently living with extremity amputations has been estimated at $billionCurrentlythe 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 stentsUnfortunatelytheir effectiveness remains limited as up toof conventional endovascular procedures will be complicated by arterial restenosis and recurrence within the first yearThis research proposal describes the development of novelballoon expandableresorbablepaclitaxel eluting scaffold designed to provide more effective and durable endovascular treatment of symptomatic PAODIts Specific Aim is to conduct the first long termcontrolledpre clinical animal study using the device Project Narrative TITLEPERCUTANEOUS TREATMENT OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WITH IMPLANTATION OF SERIALBALLOON EXPANDABLEPACLITAXEL ELUTING RESORBABLE SCAFFOLDSthe Efemoral DeviceThe pathological degeneration of arteries known asatherosclerosisis responsible for one third of all human mortalityIt represents a tremendous current and future health burden accountable for andgtmillion projected annual deaths by the yearAtherosclerosis involving lower extremity arteriesknown asperipheral arterial occlusive diseasePAODaffectsof the population overyears oldLeft untreatedsymptomatic patients can sustain severe disabilitylimb loss and or deathThe standard of care for patients with symptomatic PAOD is percutaneous peripheral interventionPPIincluding the techniques of balloon angioplastydrug coated balloon angioplastypercutaneous atherectomyand bare and drug eluting self expanding stentingUnfortunatelythe effectiveness and durability of available devices is limited as up toof conventional endovascular procedures will be complicated by arterial restenosis and recurrence within the first yearThis research proposal describes the development of novelserialballoon expandableresorbablepaclitaxeleluting scaffold designed to provide more immediately effective and durable endovascular treatment of symptomatic femoropopliteal occlusive diseaseUnlike most peripheral intravascular devices that are simply adaptations andscale upsof coronary devicesthe Efemoral scaffold system is specifically designed for the unique environment of the peripheral vasculatureIts design exploits known principles of vascular biology including thata 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 implantationa longrigid device cannot be safely implanted in an artery that bends and twists with skeletal motionlong arteries that bend and twist could be effectively treated with multipleshort stents that allow the interveningnon stented arterial segments to move unencumberedthe lengthnumber and spacing of the stent segments could be determined by the known bending characteristics of the target arteriesandarteries need only be scaffolded transientlylate dissolution of the stent will have no effect on the effectiveness of treatmentThis SBIR proposal describes the pre clinical development of the Efemoral devicea serialballoonexpandableresorbablepaclitaxel eluting scaffold designed to provide more effective and durable endovascular treatment of symptomatic PAODIts Specific Aim is to conduct the firstlong term animal study using this novel deviceEfemoral MedicalIncwas co founded by a vascular surgeon and serial biotechnical entrepreneur with over fifty years of collective experience in vascular interventionmedical device development and early stage start up initiativesThe partnership and team brings a wealth of domain specific knowledge and professional contacts for the application of new technologies for vascular diseaseThe company has already garnered private funding and made significant progress is reaching initial developmental milestonesThis application seeks to extend these early observations through the conduct of a large scalelong termcontrolled pre clinical study with the hypothesis that the vascular response to the Efemoral Device will be superior to the current standard of care