SEQUENT MEDICAL, INC. — Department of Health and Human Services SBIR Phase II: 101

Description

DESCRIPTION provided by applicant The long term goal of this Phase SBIR program is to provide a highly effective minimally invasive treatment option for patients suffering from small broad necked intracranial aneurysms To address the unmet clinical need for treating small broad necked aneurysms Sequent Medical Inc has developed the Woven EndoBridge or WEB device The WEB represents a fundamental change in the treatment of this important subset of aneurysms in its current form developed under a previous Phase SBIR the WEB is readily placed into broad necked bifurcation aneurysms and results in rapid cessation of flow into the aneurysm without need for an intraluminal support device or antiplatelet therapy The original WEB received regulatory approval for use in European Union countries as well as Chile Argentina Colombia Australia and the United Arab Emirates and has been placed into more than aneurysms worldwide mostly in medium sized aneurysms it is currently being studied under an Investigational Device Exemption IDE trial in the US Current safety and efficacy data are highly promising Notwithstanding the substantial success of the original WEB important issues patient groups and markets remain to be fully addressed Application of the WEB device to small aneurysms both ruptured and unruptured has been limited because of the relatively large sized access catheters required to place the current WEB devices The current WEB devices require catheters substantially larger than standard microcatheters of andquot inner diameter microcatheters used to treat aneurysms Over the past two years the Sequent engineering team has made rapid progress in down sizing the profile of later generation WEB devices The newest WEB devices Single Layer SL and Single Layer Spherical SLS can be placed through customized microcatheters which are still too large to facilitate treatment of the most common sizes of ruptured aneurysms Thus we propose here to proceed with development of an innovative WEB device targeting treatment of small broad necked aneurysm including those that are ruptured This will entail re engineering the WEB device for use with microcatheters Aim and retesting the device in a standard model system with Dr Kallmes at the Mayo Clinic Aim Our experience with the original WEB stands as a Phase I equivalent proof of concept that WEB devices are feasible and of great medical utility indeed our original work was so rapidly completed that we proceeded with development phases independently rather than waiting for a Phase II SBIR Thus while independently pursuing an IDE on the original WEB device our originally intended Phase II we now propose a Direct Phase II to adapt the WEB for use in standard sized access catheters in aneurysms of any morphology and thus markedly expand the anticipated utility of the device At the successful conclusion of this Phase II SBIR we will be poised to study the newly adapted WEB device in an IDE Notably the progress of the current WEB model reduces the regulatory and technical risk for the development of this new device which would provide a breakthrough in the treatment of small broad necked aneurysms PUBLIC HEALTH RELEVANCE The goal of this program is to provide a highly effective minimally invasive treatment option for patients suffering from a dangerously weak blood vessel in the brain cerebral aneurysms Despite many advances in treating cerebral aneurysms small aneurysms with wide neck openings remain particularly difficult to treat With our success in creating an effective minimally invasive device the Woven EndoBridge or WEB to treat larger wide necked aneurysms Sequent Medical now proposes to address these smaller aneurysms including those that occur at blood vessel junctions bifurcated aneurysms or that have ruptured with a smaller and more versatile device system the WEB