Self-expanding injectable for for non-compressible wounds
BREAKTHROUGH BLEEDING CONTROL FOR THE BATTLEFIELD
From the advanced biomaterials for bleeding control from Medcura, comes another in an unprecedented series of FDA Breakthrough Device Designations from its LIFETM Hemostasis Technology platform, awarded for military and traumatic injury applications (LifeFoam,2019; formerly Gel-e).1,2
The goal of the FDA breakthrough devices program is to provide timely access to important breakthrough medical devices by accelerating the development, assessment, and review of the device or technology, within the standards for premarket approval, 510(k) clearance, consistent with the agency's mission to protect and promote public health.
Medcura’s LifeFoam™ Military is intended for use as an internal hemostatic device for the control of severe, life-threatening bleeding from wounds in the abdomen that are not amenable to compression or tourniquet application; most often found in battlefield conditions.
To qualify as a breakthrough product, a medical device must provide more effective treatment of a life-threatening or irreversibly debilitating condition, and (i) have no approved or cleared alternatives, or (ii) offer significant advantages over existing alternatives, or (iii) be in the best interest of patients.1
LifeFoam is designed to expand exponentially, once delivered into the abdominal cavity. Here, at tissue interface, it provides a matrix for platelet adhesion, aggregation and the unique mucoadhesion action of modified chitosan at the damaged tissue sites — to isolate and stabilize bleeding at its source.*
- Designed for non-compressible wounds
- Ready-to-use
- Engineered for severe, internal traumatic hemorrhage
- Inserted through small wound openings or incisions
- Fills large cavities
- Excess material easily removed (by suction)
- Offers inherent antimicrobial properties of chitosan
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Surgical Solutions
Surgical blood loss can lead to complications in the operating room, including increased mortality, morbidity, blood transfusions, infections, longer procedure time and cost. Our LIFE™ Surgical Portfolio of hemostasis options is engineered to solve these problems. We strive to provide safe, efficacious, and cost-effective hemostasis tools for minor, minimal, and moderate surgical bleeding.
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LifeGel and other LIFE Surgical Portfolio formats, including application devices and tips are currently in development or feasibility. All intended uses and/or indications for use for these medical devices have not been cleared or approved by the FDA.
LifeFoam Military, including application devices and tips are currently in development or feasibility. All intended uses and/or indications for use for these medical devices have not been cleared or approved by the FDA.
1FDA Breakthrough Device Designation, LifeFoam, May, 2019 https://www.prnewswire.com/news-releases/breakthrough-device-designation-received-from-the-fda-300869734.html
*Data on file at Medcura. Based on initial and ongoing development and testing.