Team 10

SeptaNex: Septal Wall Closure Device for Complex Spaces

Team Members: Hannah Correa, Haylee Holland, Emma Rodriguez, Kyle Williams - SBHSE

Team Mentors: Dr. Stephen Pophal MD - Phoenix Children's Hospital
Dr. Jonathan Plasencia - Phoenix Children's Hospital

YouTube Link: View the video link below before joining the zoom meeting

Zoom Link: https://asu.zoom.us/j/91967348093

Abstract

SeptaNex is a medical device manufacturer dedicated to improving patient health by providing the most advanced septal wall closure device to physicians and patients and delivering exceptional value to stakeholders through our innovation and continued advancement. The current closure devices on the market for atrial and ventricular septal defects are catheter-based devices that open like umbrellas and contain circular contact surfaces to pinch the hole of the septal wall. However, these current devices do not effectively close elongated or irregular holes, or holes in complex spaces of the heart due to interference of nearby cardiac structures. SeptaNex is focused on delivering a novel septal wall closure device that will safely and effectively close irregular defects in complex spaces of the heart. We have conducted extensive research and are continuously innovating to deliver a prototype for our septal wall closure device. The technical specifications for our device are implantability, durability, safety, reactivity, with a stable insertion and efficient delivery that is immovable. We have identified relevant testing standards to validate these specifications in our prototype. Our septal occluder device will be deployed via a catheter inserted into the femoral vein, then deployed into the heart at a velocity of 28 cm/s and at a 64 degree angle. The nitinol wire used in our device has a Young’s Modulus of 75 GPa and a degradation rate of 2.226*10^-3 mm/year. Our device will have various different sizes, to treat different sized defects, ranging from a diameter of 14 mm to 30 mm. Through these specifications, we have successfully achieved the technical specifications of our septal occluder and verified the effectiveness of our device. SeptaNex is dedicated to ensuring a successful launch for the septal wall closure device for atrial and ventricular septal defects and is working diligently with academic and clinical mentors.

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