Research Project
9301690
PROJECT SUMMARY ? Clinical Evaluation of a Resorbable Inferior Vena Cava Filter Pulmonary embolism (PE) is the 3rd leading cause of death, claiming the lives of at least 100,000 Americans annually ? more than breast cancer, AIDS, and vehicle fatalities combined. Metallic Inferior Vena Cava (IVC) filters have been proven effective in reducing PE to about 1-2% in at risk populations; however, they come with a heavy post deployment price, namely the expensive retrieval procedure and long term complications such as caval penetration and end organ puncture. Our proposal is the continued development to FDA clearance of the first totally absorbable IVC filter to prevent PE. Following dissolution of blood clots, the filter itself vanishes into CO2 and H2O within 8 months. The value proposition is the prevention of PE without requiring filter removal, and alleviation of life-threatening, long term complications of metallic IVC filters. The IVC filter prophylaxis market has been growing 26% annually and is currently $500M, with an untapped market opportunity of approximately 10-fold. This Phase IIB SBIR program is focused on advancing the totally absorbable IVC filter and delivery system through a clinical trial at leading US academic hospitals in the pursuit of FDA 510(k) clearance. Phase II feasibility has been established with MD Anderson Cancer Center and validated through 5 publications in leading peer-reviewed medical journals. These studies have demonstrated preliminary safety and efficacy in large animals where the filter provided 100% clot capture when challenged with thrombus, without filter migration (0%), caval penetration (0%), caval thrombosis (0%) or PE (0%). The FDA has been very receptive to our totally absorbable IVC filter and claimed our approach is both ?comprehensive? and ?well thought out? following our two Pre-submission meetings. Aim 1: Complete Filter and Delivery System - finalize filter and catheter delivery system with goals: ? Meet ISO medical device standards: 37137,10993,25539-3,17137,10555-1,11070,11135,11607-1, ? Demonstrate one-year shelf life in real-time aging studies, and 95% functionality with 100 units. Aim 2: Conduct US Pivotal Clinical Study ? conduct multicenter clinical trial (6 month follow up) with goals: ? Recruit 80 patients (70% with proven VTE and contraindicated to anticoagulants, 30% prophylaxis), ? 82% clinical success (successful technical deployment without subsequent PE or other complications), ? Pulmonary embolism ? 5%, IVC filter occlusion ? 10%, and filter migration ? 1% per SIR guidelines, Aim 3: File Regulatory Submissions ? file appropriate regulatory documents in collaboration with CRO: ? File IDE with FDA following completion of filter and delivery system preclinical studies and FIH, ? File 510(k) package for FDA clearance following multicenter pivotal clinical study, ? Seek strategic partner for world-wide sales and distribution.
