Medcura Inc, a medical device provider devoted to revolutionarily advancing the management of surgical bleeding, has disclosed that the U.S. Food and Drug Administration (FDA) has given its Breakthrough Device Designation to its LifeGel Absorbable Surgical Hemostat. LifeGel is the first-of-its-kind hemostatic operator to be awarded the Breakthrough Designation for a brand-new and greatly distinctive usage: in surgical procedures (aside from ophthalmic and urological) as an aider hemostatic device when control of minimal, mild, and moderate bleeding by customary procedures is ineffective or arduous. Owing to its no-swell characteristics, LifeGel can be employed in procedures where swelling cannot be endured.
The FDA created the breakthrough program for therapeutic devices that are capable of providing more effective treatments for life threatening or disabling diseases or conditions. The program provides a number of benefits, including expedited regulatory review of applications, increased collaboration between the FDA and its experts throughout the review process, and improved opportunities for interaction. Additionally, the program gives manufacturers of breakthrough medical devices the chance to access a speedier review process and more readily engage with FDA experts. With Breakthrough Device designation, manufacturers are better able to align their product with FDA standards, ultimately leading to more efficient and improved potential treatments for patients in need.
According to Medcura’s press release, LifeGel is an innovative new hemostatic agent designed to provide superior performance against existing hemostatic agents on the market. Unlike many of its counterparts, LifeGel does not swell upon application and has been designed specifically not to cause compression in confined spaces such as the spinal canal where up to 60% of hemostatic agents are used. This proprietary and patented innovation eliminates the chance of nerve compression and the adverse events that can lead to such as paralysis. Additionally, LifeGel’s formulation contains no human or animal proteins, including thrombin, and is ready-to-use with no pre-mixing, preparation or cold chain storage required. As a result, it can help save precious time and money that would otherwise go toward controlling and resolving uncontrolled bleeding. Furthermore, it also offers considerable cost savings compared to other hemostatic products. Medcura believes that the various advantages and cost benefits offered by LifeGel can easily position it as a future standard of care for surgical bleeding management.