Microvention Non-fluoroscopic endovascular aortic balloon occlusion device

This announcement is to provide notice that The U.S. Army Contracting Command, Aberdeen Proving Grounds, Natick Contracting Division, Ft. Detrick, on behalf of Naval Medical Research Center intends to negotiate the sole source award under FAR 6.302-1 (b)(1)(i), Only one responsible source and no other supplies or services will satisfy agency requirements, to Microvention, Inc. to support the product development and delivery of a non-fluoroscopic endovascular aortic balloon occlusion device to stop massive hemorrhage. The product development will be conducted through a protocol supported by the Advanced Medical Development (AMD) office at the Naval Medical Research Center (NMRC). This technology is proprietary to Microvention. Microvention is the only responsible source capable of effectively supporting this requirement, based on the following rationale: 1. The Microvention temporary occlusion balloon catheter (TOBAC) device for stabilization of massive torso hemorrhage in the field is a unique device that has no equivalent when considered against other current designs. There is currently an unmet need of endovascular stabilization of incompressible hemorrhage while patients are being transported to a hospital for further management. This device addresses key issues with other devices, which chiefly include, the capability for use in a fluoroscopy free environment, provision of direct feedback concerning internal anatomic landmarks, and protection against aortic injury that may result from over inflation of standard devices in the field. This device has emerged through joint planning and invention between Microvention, Inc and the University of Virginia (UVA). Microvention, Inc possesses unique engineering and production capabilities which are critical to the design of this device. 2. Microvention is the proprietary owner of the technology and endovascular device, thus, the only company that can produce and further develop the TOBAC. Microvention, Inc., Tustin, California, was founded in 1997 to develop and manufacture unique therapeutic devices for the neurovascular embolization market. Utilizing unique materials and innovative processes, Microvention's products are intended for the treatment of a wide spectrum of vascular diseases that, because of their morphology, location, or patients general medical condition, are considered high risk for management by traditional operative techniques. 3. Microvention has developed and utilizes a number of unique proprietary processes for catheter construction and microbraiding that will facilitate the development and manufacturing of the proposed Temporary Occlusion Balloon Catheter (TOBAC) system. These techniques cannot be replicated at other manufacturing facilities and are critical to the production of the aortic balloon occlusion system. While this notice is not a request for competitive proposals, responsible parties purporting to have the requisite credentials and capabilities to provide this service in fulfilling the agency's requirements must furnish, in writing, factual information, which clearly supports and demonstrates their ability to sufficiently provide these services, within 15 days to Mr. Jeremy Michaels, Contract Specialist, by email at Jeremy.d.michaels.civ@mail.mil. Any questions regarding this notice must be in writing only; no telephonic replies will be accepted. A determination not to compete this proposed action based on any responses to this notice is solely within the discretion of the Contracting Officer. The Contracting Officer for this action is Ms. Sandra O'Connell.