Clinical Evaluation of a Resorbable Vena Cava Filter

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL127734-03
Agency Tracking Number: R44HL127734
Amount: $1,754,160.00
Phase: Phase II
Program: SBIR
Awards Year: 2015
Solicitation Year: 2016
Solicitation Topic Code: NHLBI
Solicitation Number: HL16-009
Small Business Information
2315 DELTA BRIDGE DR., Pearland, TX, 77584-1566
DUNS: 078534407
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (760) 809-6390
Business Contact
Phone: (760) 809-6390
Research Institution
PROJECT SUMMARY Clinical Evaluation of a Resorbable Inferior Vena Cava Filter Pulmonary embolism PE is the rd leading cause of death claiming the lives of at least 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 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 CO and H O within 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 annually and is currently $ M with an untapped market opportunity of approximately 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 k clearance Phase II feasibility has been established with MD Anderson Cancer Center and validated through publications in leading peer reviewed medical journals These studies have demonstrated preliminary safety and efficacy in large animals where the filter provided clot capture when challenged with thrombus without filter migration caval penetration caval thrombosis or PE 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 Complete Filter and Delivery System finalize filter and catheter delivery system with goals Meet ISO medical device standards Demonstrate one year shelf life in real time aging studies and functionality with units Aim Conduct US Pivotal Clinical Study conduct multicenter clinical trial month follow up with goals Recruit patients with proven VTE and contraindicated to anticoagulants prophylaxis clinical success successful technical deployment without subsequent PE or other complications Pulmonary embolism IVC filter occlusion and filter migration per SIR guidelines Aim 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 k package for FDA clearance following multicenter pivotal clinical study Seek strategic partner for world wide sales and distribution PROJECT NARRATIVE Clinical Evaluation of a Resorbable Inferior Vena Cava Filter Between to Americans die annually from pulmonary embolism more than breast cancer AIDS and motor vehicle accidents combined representing the rd leading cause of death The US Surgeon General has recognized these alarming statistics and issued a formal Call to Action with the Director of the National Heart Lung and Blood Institute proclaiming There are few public health problems as serious as DVT PE yet these diseases receive so little attention The objective of the project is to conduct a multicenter clinical trial per FDA recommendation among leading US hospitals to demonstrate both the safety and efficacy of a novel totally absorbable inferior vena cava filter that prevents pulmonary embolism and then vanishes from the body without intervention

* Information listed above is at the time of submission. *

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