For the treatment of second-degree burns, the US FDA approves the medical device InnovaBurn from Convatec.

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The InnovaBurn placental extracellular matrix medical device from Convatec has been approved by the US Food and Drug Administration for the care of difficult surgical wounds and burns, including partial-thickness second-degree burns. According to the American Burn Association’s ameriburn.org, which uses the most recent data available from the Centers for Disease Control and Prevention, about 500,000 people seek medical attention each year for burn injuries. Over 40,000 of these people had to be hospitalised for burn wounds.

As the first and only placental-derived medical device created for the management of burns, complicated surgical wounds, and difficult-to-heal wounds, the InnovaBurn device joins Convatec’s InnovaMatrix platform. InnovaMatrix products, such as the brand-new InnovaBurn ECM, are manufactured using Convatec’s patented TriCleanse Process, providing doctors with a next-generation medical device that maintains the placenta’s inherent advantages in addition to a medical device’s dependability, reproducibility, and safety. It is possible to buy InnovaBurn commercially.

Debra Noble, sales director of Convatec’s US Burn Division, described InnovaBurn as an inventive development in ECM technology for patients with partial-thickness, second-degree burns. “InnovaBurn gives burn patients access to the most cutting-edge and effective placental ECM technology. Our distinctive source material enables us to produce some of the largest ECM sizes in the market at substantially lower costs, enabling more patients to benefit from this cutting-edge technique. InnovaBurn’s unique sizing and user-friendly design are valued by doctors who use it to treat bigger wounds like burns.

InnovaBurn is a xenograft indicated for the therapy of wounds that is managed for genetic variability, environmental conditions, and lifestyle parameters, such as food and activity levels. In addition to traumatic lacerations, dehisced incisional wounds, pressure ulcers, venous ulcers, post-Mohs surgical wounds, post-surgical incisions, and diabetic ulcers, the device can also be utilised on these conditions. No particular preparation, placement orientation, tissue tracking, or storage is needed with InnovaBurn. It adapts to the wound location and clings to it.

With Convatec’s patented TriCleanse Placental Extracellular Matrix Process, which effectively decellularizes the ECM, cleans the tissue, and inactivates viruses while preserving the ECM’s structural proteins that can aid in healing, InnovaMatrix products are produced. In order to bridge over the defect and remodel it, host cells need a clear, effective matrix. Using the 510(k) medical device process, InnovaBurn was approved by the FDA. The 510(k) or Premarket Approval process is used by the FDA to assess and approve items that meet certain requirements for medical devices. FDA-approved gadgets go through a thorough review process. InnovaBurn is the newest member of the InnovaMatrix product family, which also comprises the particle InnovaMatrix PD and the placental ECM device InnovaMatrix FS, both of which are suited for wounds with high exudate. In order to address unmet clinical requirements in surgical wounds, chronic wounds, and burns, Convatec’s Advanced Tissue Technologies, formerly Triad Life Sciences, focuses on regenerative medicine and producing biologically derived novel products.

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