Sam Brusco, Associate Editor01.12.23
Medcura, a company focused on improving surgical bleeding management, has gained U.S. Food and Drug Administration (FDA) breakthrough status for its LifeGel absorbable surgical hemostat.
According to the company, LifeGel is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new, highly differentiated indication: “in surgical procedures (except in ophthalmic and urological) as an adjunctive hemostatic device when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical. Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.”
"We're very pleased for the opportunity to continue working closely with the FDA to improve a surgeon's ability to control and stop the wide range of bleeding scenarios for which the Breakthrough Designation was awarded," Medcura president and CEO Jim Buck told the press. "This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management."
Medcura’s formulation was designed not to swell on application to eliminate chance of spinal cord compression caused by swelling hemostatic agents. LifeGel contains no human or animal proteins and requires no pre-mixing, preparation, or cold chain storage.
"Over the past decade, there have not been meaningful advancements in the safe control of surgical bleeding using flowable technologies which are routinely used in many high-volume and high-value procedures," said Medcura's chief medical officer, neurosurgeon Dr. Ken Renkens. "With the experience we've gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control the wide range of challenging bleeding situations a surgeon often confronts."
According to the company, LifeGel is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new, highly differentiated indication: “in surgical procedures (except in ophthalmic and urological) as an adjunctive hemostatic device when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical. Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.”
"We're very pleased for the opportunity to continue working closely with the FDA to improve a surgeon's ability to control and stop the wide range of bleeding scenarios for which the Breakthrough Designation was awarded," Medcura president and CEO Jim Buck told the press. "This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management."
Medcura’s formulation was designed not to swell on application to eliminate chance of spinal cord compression caused by swelling hemostatic agents. LifeGel contains no human or animal proteins and requires no pre-mixing, preparation, or cold chain storage.
"Over the past decade, there have not been meaningful advancements in the safe control of surgical bleeding using flowable technologies which are routinely used in many high-volume and high-value procedures," said Medcura's chief medical officer, neurosurgeon Dr. Ken Renkens. "With the experience we've gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control the wide range of challenging bleeding situations a surgeon often confronts."