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Integrated Maglev Pump-Oxygenator for Respiratory Support

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42HL084807-02
Agency Tracking Number: HL084807
Amount: $1,395,480.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Timeline
Solicitation Year: 2008
Award Year: 2008
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
45 FIRST AVENUE
WALTHAM, MA 02451
United States
DUNS: 130456952
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 KURT DASSE
 (781) 622-5073
 KDASSE@LEVITRONIX.COM
Business Contact
Phone: (781) 622-5073
Email: kdasse@levitronix.com
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): Chronic lung disease remains America's third largest cause of death. Adult respiratory distress syndrome (ARDS) alone afflicts approximately 150,000 patients every year with a mortality rate between 30-70%. Current ther
apy for respiratory failure includes mechanical ventilation and extracorporeal membrane oxygenation (ECMO). Mechanical ventilation is effective for short term support, yet the sustained tidal volumes and airway pressures often used may also damage the lung
s via barotrauma, volutrauma, and other iatrogenic injuries. While ECMO systems simulate physiological gas exchange, these systems are limited by the complexity of its operation, bleeding, and reduced patient mobility. These factors lead to the need for hi
gher than desired priming volumes and membrane surface areas. In order to overcome these limitations, we propose to develop an integrated maglev pump-oxygenator (IMPO), which incorporates durable membranes and magnetically levitated blood pump technology t
o produce a highly efficient respiratory support system with low priming volumes. The IMPO is intended to be a self-contained blood pump and blood oxygenator assembly enabling rapid deployment for a patient requiring ECMO or trauma support for 3 to 14 days
or longer. In Phase I of the project, we modeled, fabricated and tested a prototype IMPO device and assessed its gas transfer efficiency and biocompatibility in vitro and in vivo. In the current Phase II research, we intend to complete the design and vali
dation of the IMPO device, to assess in vivo performance and biocompatibility, and to launch device readiness testing in anticipation of clinical trials. Accordingly, our specific aims include: Specific Aim 1: Design the IMPO system with optimized pump- im
peller and fiber configuration to maximize oxygen transfer and biocompatibility. Specific Aim 2. Complete IMPO fabrication and perform in vitro assessment of oxygen transfer and biocompatibility. Specific Aim 3. Demonstrate hemodynamic performance and bioc
ompatibility of the IMPO in an animal model. Successful completion of this project will result in the development of a portable pump oxygenator system characterized by improved hemocompatibility and oxygen efficiency. We anticipate that such as system will
be capable of providing long term respiratory support (weeks to months) and thus should have significant impact on the reduction of mortality due to severe, acute respiratory disorders.7. Narrative Lung disease is the third largest cause of death
in the United States of America, accounting for approximately 1 out of every 7 adult deaths. It is estimated that 30 million Americans are living with chronic lung disease. The current technology for respiratory failure is complex, is associated with multi
ple complications and is very costly. The proposed Integrated Membrane Pump Oxygenator (IMPO) is a simple, portable and affordable technology designed to provide a better option for the treatment of these patients with severe, acute potentially reversible
respiratory failure.

* Information listed above is at the time of submission. *

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