1 / 12

August 2010

Transforming Critical Care TM. Integrated Medical Systems, Inc. Matthew E. Hanson, Ph.D. Vice President Phone 562-498-1776 ext. 203 Fax 562-597-6423 Email matthewhanson@LSTAT.com. August 2010. Technology: LS-1™. LS-1 “Suitcase Intensive Care Unit” FDA-cleared CE Mark-cleared

kyria
Télécharger la présentation

August 2010

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Transforming Critical Care TM Integrated Medical Systems, Inc.Matthew E. Hanson, Ph.D.Vice PresidentPhone 562-498-1776 ext. 203Fax 562-597-6423Email matthewhanson@LSTAT.com August 2010

  2. Technology: LS-1™ • LS-1 “Suitcase Intensive Care Unit” • FDA-cleared • CE Mark-cleared • Airworthiness (pending) • Supplies • Per-Patient Disposable (PPD) packs • Additional batteries • Accessories • Auxiliary infusion pumps • Upgrades • Hardware and Software

  3. Technology: LS-1 Capabilities • Medical • Ventilator • Infusion • One (1) installed low rate pump • Up to four (4) additional low or high rate pumps • Physiological Monitor • SpO2, two temperature, two invasive pressure, one non-invasive pressure, 3/5-lead ECG, EtCO2 • Fluid Warmer • Data • Centralized control and display • Remote control and display (wired or wireless) • Network connectivity • USB port • Greater than 72 hours of continuous data recording from all devices • Utilities • Onboard “hot-swappable” batteries • Accepts off-board sources of power (facility or vehicle, US or EU) • Accepts off-board sources of oxygen (high pressure cylinder/line, or low pressure oxygen concentrator)

  4. Need / Indications: Military Requirements “ En Route Care consists of capabilities for continuing care begun at each echelon while a casualty is moving from echelon to echelon or place-to-place” (Lines 153-156) "Technological advances in attended, compact, self-contained enclosures with embedded diagnostic and interventional therapy features should be aggressively pursued." (line 586-587) As a minimum, alternatives should be included that incrementally increase capabilities (i.e., evolutionary acquisition), especially since medical technologies often advance faster than the time required for fielding a system. (Lines 667-670)

  5. Sustained Vision • LSTAT References In The June 2009 “AMEDD Futures 2039 Final Report”: • "Potential breakthroughs in resuscitative care include full development of the Life Support for Trauma and Transport (LSTAT)…." [Page 54] • "As forecast above, Life Support for Trauma and Transport (LSTAT) systems will be widely utilized." [Page 54] • "Full development of the Life Support for Trauma and Transport (LSTAT) high-tech mobile trauma pods." [Page 60] • Recommendations: "Set shorter term priorities for AMEDD R&D efforts, e.g …accessories for LSTAT system." [Page 60] • Recommendations: "Improve LSTAT so that it is light weight, self-contained, and has an adequate built-in power source." [Page 61] • Among Top Five Listed Major Accomplishments: "Life Support for Trauma and Transport (LSTAT) medical system." [Page 205] • Implications and Recommendations for AMEDD: "Improve LSTAT so that it is light weight, self-contained, and has built-in power source." [Page 205]

  6. Need / Indication:Civilian Status Quo • Critical care patients represent 20% of admissions, and generate 80% of hospital costs, including a substantial amount in capital expenditures • Overarching problems with status quo arrangements for dealing with critical care patients • Dangerous gaps in care reduce safety • Significant inefficiencies increase costs • Military experience is consistent with commercial experience

  7. Key Research • Clinical Studies • Palomar Pomerado Health • Start Fall 2010 • Validation of clinical and economic benefits of LS-1 applied to In-Hospital Transport and continuous care • Major Civilian Trauma Center • Start Fall 2010 • Validation of clinical and economic benefits of LS-1 remote control and continuous care • Applications in Low Resource Environments • Bench Top Studies • Integrated Clinical Environment (MassGen/ CIMIT) - completed • Closed-loop control ventilation (NMRC-SD) - underway • Data system interoperability (Moberg Research) - pending

  8. Connectivity • Port: Universal Serial BusProtocols: USB 1.1, USB2.0, various device classes implemented (e.g., mass storage, wireless, etc.) • Port: LAN Ethernet (RJ-45) TIA/EIA-568BProtocols: IEEE 802.3; 100BaseTX (IEEE 802.3u) , 10BaseT (IEEE 802.3i), TCP/IP, UDP/IP, SSH2, various others • Port: Wireless EthernetProtocols: IEEE 802.11b/g/n, TCP/IP, UDP/IP, SSH2, various others • Port: Auxiliary Port (proprietary)Protocols: proprietary • Company Vision for Interoperability • Standard output adapted to multiple information systems (Cerner, etc)

  9. Key Results • Clearance Status • FDA cleared • CE Mark • Export • Airworthiness (pending) • Market Availability • Ten (10) production units delivered to U.S. Army • Sales to international military medical customers have begun

  10. Key Results • Publications • “Integrated Diagnostic and Treatment Devices for Enroute Critical Care of Patients within Theater”, Palmer, R. RTO-MP-HFM-182, NATO Symposium on "Use of Advanced Technologies and New Procedures in Medical Field Operations“, April 2010, Essen, Germany • “Critical Care on the Go - Military Project Tests Portable Case Containing ICU Equipment”, R-Tech Newsletter, Department of Homeland Security, pp.3-5, Vol 3, Issue 4, April 2010 • “Interoperability through Integration”, MacLaren, R. FDA Workshop on Medical Device Interoperability, January 2010 • “Battlefield Hospitals Re-Envisioned”, Michel, J. Military Medical Technology, p. 7, Vol 13, Issue 8, December 2009 • “Military’s Influence Extends Beyond the Battlefield”, AAMI News, Association for the Advancement of Medical Instrumentation, P. 1, Vol 44, No. 9, October 2009 • “Integrated Medical Systems Puts up the MedEx for Military Testing”, Panaitescu, F., Softpedia, August 2009

  11. Key Results • News Releases • Former Air Force Surgeon General Roudebush Joins Integrated Medical Systems’ Advisory Board, February 2010 • Integrated Medical Systems Receives CE Mark for World's First 'Suitcase' Intensive Care Unit, September 2009 • Former Veterans Affairs Secretary Peake Joins Integrated Medical Systems' Advisory Board, August 2009

  12. LSTAT G6™The Obvious Solution • Initial Capabilities Document for Joint Theater Combat Casualty Care • "Technological advances in attended, compact, self-contained enclosures with embedded diagnostic and interventional therapy features should be aggressively pursued." (line 586-587) • AMEDD Futures 2039 Final Report (June 2009) • "Potential breakthroughs in resuscitative care include full development of the Life Support for Trauma and Transport (LSTAT)…." [Page 54] • Among Top Five Listed Major Accomplishments: "Life Support for Trauma and Transport (LSTAT) medical system." [Page 205] Ground Vehicles Hospital (Fixed or Field / TDA or MTO&E) Air Vehicles (Fixed-Wing/Rotor-Wing) This product is still underdevelopment, is not being offered for sale, and has not yet been cleared for marketing by the U.S. FDA

More Related