Novel Biological Tissue Lined Vascular Stent Crimping and Delivery System
Department of Health and Human Services
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Small Business Information
10265 Carnegie Avenue, Cleveland, OH, 44195
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Cardiovascular disease is the leading cause of death in the United States and atherosclerosis is its major cause. Based on statistics for aging population alone, a conservative prediction is there will be approximately 190,000 peripheral vascular procedures performed in 2020. This disease has significant adverse effects on the quality of life and survival, with mortality as high as 30% in 5 years and 50% in 10 years. A major component of peripheral arterial disease (PAD) is obstruction of blood flow to the lower extremities from atherosclerosis. Of the arteries in the lower extremity, the superficial femoral artery (SFA) is the most commonly affected by PAD with over 50% of all PAD involving the SFA. Despite enthusiasm fo r drug-coated stents and atherectomy devices, there is no ideal endovascular solution to treating lower extremity occlusive disease, as they have not yet proven to be efficacious in the SFA and in some cases have performed worse than bare metal stents. Per itec Biosciences has developed a novel peritoneum lined stent (PLS) and unique delivery system. The PLS has shown excellent performance in animal and early human clinical studies. The PLS is attached to a self expandable stent which must be crimped and att ached to the catheter at the time of surgery for deployment in the SFA. The unique tissue lined stent requires special handling in a novel delivery system developed by the company to maintain its physical and biological integrity. The existing PLS and deli very system is proficient in providing the stent for clinical application. But the process is time consuming, operator dependent, requires 4 to 6 minutes, and needs to be improved for clinical acceptance and commercial success. We have some unique and inno vative crimping system concepts for the PLS that permits a safe, simple, and fast process for mounting it on a catheter in the clinical setting. In Phase I, 3-D models of stent crimping concepts for a tissue lined stent will be developed, constructed, and evaluated for key performance parameters using laboratory models. Based on the screening of potential crimping techniques defined in Phase I, in Phase II, the best system(s) will be identified. Prototypes will be constructed and stents will be crimped with the new system which will be evaluated in vitro and in vivo to demonstrate that the new crimping system has not compromised the physical or biological integrity of the PLS. We will successfully design a new crimping method for the current PLS delivery sys tem that will decrease the preparation time in the surgical suite, be independent of operator skill, and require one half the current time to complete the steps prior to stent deployment. This will allow the use of the unique biocompatible PLS to meet a se rious and growing unmet need in the treatment of vascular atherosclerosis in the lower extremities. PUBLIC HEALTH RELEVANCE: With the rapid increase in the atherosclerosis associated with aging, obesity, and diabetes, there is a serious unmet need for trea tment of lower extremities artery disease resulting from obstruction of blood. This disease has significant adverse effects on the quality of life and survival, with mortality as high as 30% in 5 years and 50% in 10 years. The superficial femoral artery (S FA) is the most commonly affected artery in the leg. There is currently no ideal endovascular solution to treating lower extremity occlusive disease. The unique peritoneum lined stent can provide effective treatment to meet this serious and growing need in the treatment of vascular atherosclerosis in the lower extremities.
* information listed above is at the time of submission.