SBIR-STTR Award

Universal Medical Device Identifier to Improve Emergency Triage
Award last edited on: 2/1/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$2,745,349
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
John E Porterfield

Company Information

Bridgesource Medical Corporation (AKA: BMS)

8501 Rockwood Lane
Austin, TX 78757
   (612) 730-1091
   N/A
   www.bridgesourcemedical.com
Location: Single
Congr. District: 10
County: Travis

Phase I

Contract Number: 1R43AG059499-01
Start Date: 5/1/2018    Completed: 4/30/2019
Phase I year
2018
Phase I Amount
$224,954
Cardiovascular Implantable Electronic Devices (CIEDs) like a Permanent Pacemaker or Implantable Defibrillator are implanted in over 3 million Americans, with the average age of implantation in the 60s, 40% ? 70 years old, and 28% ? 80 years old. When a patient presents to the Emergency Department (ED) with an unknown CIED, reprogramming of the device is often necessary for their treatment. Every patient should know their device type and manufacturer. This information is particularly important, as every device can be interrogated only by a programmer (a custom computer and magnetic wand) from the CIED's specific manufacturer. However, in emergency situations, elderly patients may not have their device information or may be unable to communicate with hospital personnel, leading to delays in proper treatment. Most often, ED staff use an x-ray to attempt to read the manufacturer and device type, simply to help determine the correct manufacturer to ask for assistance. To facilitate prompt and thorough patient treatment, CIED manufacturers typically provide personnel who are on call in or near medical facilities to assist with any device-related issues. To solve this problem, BridgeSource Medical proposes a portable handheld device that can interrogate CIEDs from any manufacturer either in the ED, or in transit to the ED, eliminating the need for a time-consuming and unnecessary x-ray, and enabling first- line medical personnel. The proposed device identifier works by mimicking the “wakeup call” communication of the five major CIED programmers in sequence, and would identify each device by analyzing the response from the CIED.

Public Health Relevance Statement:
Project Narrative In the US, patients presenting to the Emergency Department with an unknown Cardiac Implanted Electronic Device represent a unique problem. Often correct treatment requires the reprogramming of the device by the manufacturer, but it is impossible to quickly determine the manufacturer of each device in the Emergency Department.

Project Terms:
Accident and Emergency department; Age; American; Arrhythmia; base; Boston; cardiac device; cardiac implant; Cardiovascular system; Caring; Clinical; clinical practice; commercialization; Communication; Computers; Consult; Custom; design; Device Designs; Devices; Diagnostic; Early treatment; Electronics; Emergency Department Physician; Emergency Situation; empowered; Engineering; Evaluation Studies; experience; Grant; handheld equipment; Health; Health Personnel; Hospital Personnel; Hospitals; Human; Human Resources; human study; Implant; Implantable Defibrillators; implantable device; implantation; Institutes; Leadership; Legal patent; Length of Stay; Magnetism; Manufacturer Name; Medical; Medical Device; Modeling; mortality; Names; novel; older patient; operation; Pacemakers; patient safety; Patients; Performance; Phase; portability; Principal Investigator; Problem Solving; Process; Productivity; programs; prototype; Reading; Research Personnel; response; Risk; Roentgen Rays; Saint Jude Children's Research Hospital; Small Business Innovation Research Grant; System; Techniques; Testing; Texas; Thoracic Radiography; Time; Translational Research; Triage; Work

Phase II

Contract Number: 2R44AG059499-02
Start Date: 5/1/2018    Completed: 7/31/2021
Phase II year
2019
(last award dollars: 2023)
Phase II Amount
$2,520,395

Cardiovascular Implantable Electronic Devices (CIEDs) like a Permanent Pacemaker or Implantable Defibrillator are implanted in over 3 million Americans, with the average age of implantation in the 60s, 40% ? 70 years old, and 28% ? 80 years old. When a patient presents to the Emergency Department (ED) with an unknown CIED, reprogramming of the device is often necessary for their treatment. Every patient should know their device type and manufacturer. This information is particularly important, as every device can be interrogated only by a programmer (a custom computer and magnetic wand) from the CIED’s specific manufacturer. However, in emergency situations, elderly patients may not have their device information or may be unable to communicate with hospital personnel, leading to delays in proper treatment. Most often, ED staff use an x-ray to attempt to read the manufacturer and device type, simply to help determine the correct manufacturer to ask for assistance. To facilitate prompt and thorough patient treatment, CIED manufacturers typically provide personnel who are on call in or near medical facilities to assist with any device-related issues. To solve this problem, BridgeSource Medical proposes a portable handheld device that can interrogate CIEDs from any manufacturer either in the ED, or in transit to the ED, eliminating the need for a time-consuming and unnecessary x-ray, and enabling first-line medical personnel. The proposed device identifier works by mimicking the “wakeup call” communication of the five major CIED programmers in sequence, and would identify each device by analyzing the response from the CIED.

Public Health Relevance Statement:
Project Narrative In the US, patients presenting to the Emergency Department with an unknown Cardiac Implanted Electronic Device represent a unique problem. Often correct treatment requires the reprogramming of the device by the manufacturer, but it is impossible to quickly determine the manufacturer of each device in the Emergency Department.

Project Terms:
Accident and Emergency department; Age; American; Area; Arrhythmia; base; Cardiac; cardiac device; cardiac implant; Cardiovascular system; Caring; Clinical; clinical practice; commercialization; Communication; Computers; Consult; Consumption; Custom; design; Device Designs; Devices; Diagnostic; Electromagnetics; Electronics; Emergency Department Physician; emergency service responder; Emergency Situation; empowered; Evaluation; experience; Goals; handheld equipment; Health; Health Personnel; Hospital Personnel; Hospitals; Hour; Human; Human Resources; human study; Implant; Implantable Defibrillators; implantable device; implantation; improved; innovation; Institutes; Internet; Length of Stay; Magnetism; Manufacturer Name; Marketing; Mechanics; Medical; Medical Device; Modeling; mortality; older patient; operation; Pacemakers; Patients; Phase; Pilot Projects; portability; Principal Investigator; Problem Solving; Process; Production; programs; prototype; Reading; Reporting; Research Personnel; response; Risk; Roentgen Rays; Role; Saint Jude Children's Research Hospital; Sales; Scientist; Services; Small Business Innovation Research Grant; System; Testing; Texas; Thoracic Radiography; Time; Training; Triage; Update; verification and validation; wasting; Work