SBIR Phase I: A Diagnostic Catheter for Treating Obstructions/Occlusions Within a Body Lumen or Vessel

Embark Medical, Santa Clara CA

Investigators

Abstract

This SBIR Phase I project intends to design and develop an innovative medical device solution that can potentially save $1.16B to the overall US healthcare system by reducing the procedural time and decreasing the number of catheters and devices used in Peripheral Vascular lnterven6on procedures. Lower extremity peripheral arterial disease affects more than 8 million people in the United States alone. The annual healthcare expenditure spent on treating peripheral arterial disease is $4.37B. Since 2008, US Center for Medicare and Medicaid has been stressing for greater efficiency and lowering costs for Peripheral Vascular Intervention. Commonly performed Peripheral Vascular Intervention procedures in the CathLab, to treat PAD, encounter loss of guidewire access. This complication is amplified in the case of difficult to cross stenotic lesions and, in many cases, is frustrating for the physician as they have to spend several hours/procedures trying to regain guidewire access. Guidewire access is the key for a successful procedural outcome. The Project intends to reduce Peripheral Vascular Intervention cost by improving procedural efficiency by eliminating guidewire/catheter exchanges in current practice thereby reducing Cath Lab overhead costs and by reducing procedure time and effort required to acquire a good quality angiographic image. An important ancillary benefit of the innovation is that the radiation exposure to the healthcare providers and the patient can potentially be minimized due to the decreased fluoroscopic activity. The project aims to continue beyond SBIR Phase I to become a commercial product and be the standard of care for Peripheral Vascular Intervention procedures. This SBIR Phase I project is for the design and development of a .014-inch guidewire compatible low profile PTA balloon catheter with a proprietary contrast injection mechanism. This product is ideal for performing PTA interventions in difficult anatomical spaces e.g. below-the-knee peripheral vasculature. The proprietary inflation and injection system allows for treatment visualization without needing catheter exchanges or loss of guidewire access. The output of the Project intends to provide focused and sharper visualization along the entire treatment length and allows for judicious usage of radiopaque contrast in contrast sensitive patients. A feasibility prototype of the concept was tested in an animal model with promising results. The SBIR Phase I project is focused on overcoming technical challenges to design and develop the unique device design to maintain a statistically significant rated burst pressure, develop and evaluate device bond joints per ISO standard 10555-1 2013, Sterile Single Use Intravascular catheters, develop the manufacturing process and tools, to integrate the catheter multi functionality. The Project intends to design and fabricate a test fixture to simulate clinical usage of the Innovative device per FDA Class II Guidance Controls for Percutaneous Transluminal Balloon Catheters and confirm that the catheter satisfies customer requirements. The Development efforts as part of SBIR Phase I project involve utilization of iterative design process. 3-dimensional design modeling and optimization, creation of a test fixture to simulate clinical usage, iterative prototyping and testing efforts to ensure the desired device specifications are met. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.