Millipede Percutaneous Annuloplasty Ring

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DESCRIPTION (provided by applicant): Heart valve regurgitation is a serious condition related to heart disease. The most common and effective surgical method for treating this disease is with the use of an annuloplasty ring, which reduces the size of a dilated valve annulus to restore normal function. Many patients do not receive this procedure, however, either because they are too sick to undergo open heart surgery, or their condition has not yet progressed to the point at which surgery is justified. To address this large untreated patient population, many efforts have been undertaken to develop technology to repair leaky valves via catheter. Of these, the Millipede concept is the only device which can perform a true ring annuloplasty. This concept uses a ring that can both expand and contract under a radial force and has many small barbed anchors around its perimeter. The ring is mounted on the proximal end of an expandable, cone- shaped delivery tool prior to delivery. The collapsed dilator-ring assembly is advanced toward the annulus and the apex of the cone is pushed through the valve orifice. The cone is then expanded, which simultaneously expands the ring to a known diameter and forces the annulus into a circular shape with the same diameter, resulting in automatic alignment of the ring and the annulus. Once aligned, a simple forward push of the delivery tool drives the barbed anchors into the tissue and secures the ring in place. The dilator tool is then contracted down and removed. In Phase I of this project we will build functional prototypes of the ring and delivery tool and test their performance on the benchtop in pig hearts. In Phase II we will further develop this device and conduct testing necessary to achieve regulatory approval for surgical use. Also in Phase II, we will develop the delivery system needed to implant the device percutaneously. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop a sutureless annuloplasty ring for the treatment of dilated, leaking heart valves. This will lead to an annuloplasty ring that can be implanted without surgery, which will benefit a significant number of patients who have valve disease but are not candidates for surgery.