Medcura, Inc., an innovative medical device company committed to improving surgical bleeding management, announced that the U.S. Food and Drug Administration has awarded the Breakthrough Device Designation to its LifeGel ™ Absorbable Hemostat. LifeGel ™ was the first hemostatic agent to be granted Breakthrough Device Designation. It is intended for a highly differentiated and new indication in surgical procedures, except in ophthalmic or urological, as an adjunctive device hemostatic when conventional methods are ineffective or not practical. LifeGel’s no-swelling properties allow it to be used during surgical procedures that cannot tolerate swelling.
The FDA Breakthrough Devices Program offers a range of therapeutic devices with the potential to treat life-threatening diseases or conditions in a more effective manner. Breakthrough designation offers several benefits including a faster and more collaborative review for future regulatory submissions, as well as a greater opportunity to communicate with FDA experts during the review process.
Medcura’s President and CEO Jim Buck said, “We are very happy for the opportunity of continuing to work closely with FDA to improve the surgeon’s abilities to control and stop a wide range bleeding scenarios for whom the Breakthrough Designation has been awarded.” This designation allows for a closer collaboration with the FDA, which will expedite access to LifeGel by patients as a revolutionary new solution for surgical bleeding management.
Some hemostatic agents cause swelling after application. Hemostatic agents can cause nerve compression in small spaces, such as the spinal canal where they are used up to 60%. This can result in severe adverse effects, including paralysis. Medcura’s proprietary and patent formulation is designed to not swell when applied, reducing the risk of spinal cord compression due to swelling hemostatic agents.
LifeGel, unlike many hemostatic agents that contain animal or human proteins, such as thrombin and require pre-mixing or preparation, does not require cold chain storage or any other kind of preparation. LifeGel is ready-to-use, which can reduce costs, delays, risks and complications that are associated with uncontrolled blood loss. It also helps to reduce waste of expensive hemostatic material in the operating theatre. Medcura’s LifeGel platform, with its unique features and disruptive cost advantage will become the future standard for surgical bleeding control.
Ken Renkens, MD, Medcura Chief Medical Officer and neurosurgeon, said that there had been no significant advancements made in the control of surgical blood loss using flowable technology, which is routinely used for many high-volume, high-value procedures. LifeGel is easy to use and intuitive, with a proven ability to control a wide range of bleeding situations.
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