Commercialization of the Head Up CPR System for Improving Survival after Cardiac Arrest

Resuscitation Innovations Llc, Minneapolis MN

Investigators

Abstract

Abstract Sudden cardiac arrest (SCA) is a leading cause of death in the USA, with only 3-20% neurologically intact survival for >350,000 out-of-hospital SCA patients each year. Even after patients are initially resuscitated, many die within a week from severe brain injury. The goal of this application is to improve neurologically-intact survival rates after pre-hospital and in-hospital SCA through the commercialization of a novel method of CPR called Head Up Position (HUP) CPR. HUP CPR works by harnessing gravity to enhance venous blood flow from the brain to the heart, lower intracranial pressure, and enhance cardiac output. The first clinical HUP CPR device, the ELEGARDTM, was designed, built, and tested with Phase I funding support. The ELEGARD has been used to help treat >4500 SCA patients to date. Based upon early positive clinical outcomes, Phase II funding supported the development of a refined and more portable device to accelerate adoption (ELEGARD 3.0). A subsequent limited launch evaluation in 2024 was highly favorable. However, it revealed a compatibility issue where some shorter patients were slipping out of position during elevation, likely due to experiencing greater head and thorax elevation compared to taller patients. As a result, post-award efforts have focused on refining the head cradling mechanism to ensure consistent head elevation and minimize slippage for patients of all heights. Additionally, during this period, the device’s contract manufacturer suddenly closed, requiring the transfer of ELEGARD 3.0 assembly and processes to a new production facility. This transition requires significant additional resources to integrate the device into a new production facility and quality system. Given that the SBIR CRP program supports late-stage development activities, Resuscitation Innovations (RI) hopes to secure funding to 1) Optimize, manufacture, and validate an updated ELEGARD 3.0 head cradling mechanism and carrying case; and 2) Transfer manufacturing of ELEGARD 3.0 to a new ISO13854 certified production facility and complete process validations and design control transfer for commercial launch. Successful completion of these aims will accelerate commercialization and adoption of this innovative technology to improve neurologically-intact survival rates after SCA.