This program focuses on new devices that are used in the promotion of human health, such as in the diagnosis or treatment of human disease. The current award recipients involve devices that are undergoing a new stage of development, for example, from the lab to first time in humans, from pilot human studies to a formal clinical trial, or from clinical experience to commercial development. The 2013 award recipeints are Dr. Arash Khardavar and Dr. Thomas Ahlering.
Valvular heart disease is the third most common cause of heart problems in the United States.Two types of valves are currently used for replacement of the diseased valves: mechanical andbioprosthetic. Mechanical heart valves are recommended for patients aged 15-64 because theyare more durable; however, they significantly increase the risk of thromboembolism and requiresustained use of anticoagulant medication. In contrast, bioprosthetic valves do not require anysupplement drug due to their biocompatible surface and improved blood flow dynamics, whichminimizes red blood cell damage. However, they are less durable than mechanical valves andmainly used for older patients. None of these valves have the self-regenerating capacity.
To address this, we have developed a hybrid heart valve with the durability of mechanicalvalves and biocompatibility of tissue valves. This technology, which is protected by twopublished US patent applications (US20120244617 and US20120245706), a PatentCooperation Treaty (PCT) and multiple provisional patents describes a tri-leaflet heart valvewhose leaflets are hybrid, composed of an extra-thin superelastic Nitinol mesh core, tightlyenclosed by multiple, live biological layers grown similar to natural heart valve leaflets (Figure1). These hybrid leaflets possess a biological surface similar to a natural leaflet while their thinsuperelastic Nitinol mesh core replicates the strong natural extracellular matrix backbone of theleaflet to withstand the variety of loads applied to the valve in heart.The living valve tissue is composed of the smooth muscle cells (SMCs),fibroblasts/myofibroblasts and endothelial cells acquired from a peripheral vessel (e.g., thesaphenous vein) of the patient and grown over a super thin tri-leaflet Nitinol scaffold (25 micron;Figure 1a) to be surgically implanted in the patient’s heart. The ICTS grant will facilitate proof offunctionality, durability and biocompatibility of the valve in vivo in sheep. Favorable results of theanimal study will significantly accelerate our path to commercialization.The worldwide market for heart valve interventions is approximately $1.7B, and has grown at an8% CAGR over the past 5 years. Our Valve’s primary target market is patients aged 15-65. Ourvalve will be competitive in this market because it is as durable as mechanical valves but doesnot require lifelong use of anticoagulants.
The UroCool system is designed to apply targeted temperature control to the pelvic anatomy during RARP. The pelvis is cooled transrectally via a closed cycle recirculation of chilled sterile saline using a single-use disposable balloon catheter connected via a circulation IV set to a control console that is covered by a current 510(k) and commercially available. The UroCool system consists of three parts; endorectal cooling catheter, console and circulating cassette.
A single-use, non-sterile, endorectal cooling balloon catheter comprised of: dual balloons; a central shaft constructed of PVC with fluid supply and return lumens to which the two concentric polyurethane balloons are attached; and an electrically isolated YSI 400S type thermistor for sensing temperature. The smaller internal balloon termed the “cooling balloon” is made of inextensible polyurethane.
A control console that provides the cooling energy and control of temperature. It is comprised of a refrigeration system, an interface for the cassette’s circulating pump and heat exchange reservoir/bath and a pressure sensor, along with electronic hardware and control software which collectively serve to condition and circulate a heat transfer fluid in closed-loop fashion through the catheter for the purpose of removing heat from the pelvic space.