The FDA cleared Convatec’s InnovaBurn placental extracellular matrix medical device for managing second-degree burns.
Convatec has received clearance from the US Food and Drug Administration for its InnovaBurn placental extracellular matrix medical device for managing complex surgical wounds and burns, including partial-thickness second-degree burns.
The InnovaBurn is a placental-derived medical device designed to manage burns, complex surgical wounds, and hard-to-heal wounds.
Manufactured with Convatec’s proprietary TriCleanse Process, InnovaMatrix products, including the new InnovaBurn ECM, give physicians a next-generation medical device that preserves the inherent benefits of the placenta along with the reliability, reproducibility, and safety of a medical device. InnovaBurn is commercially available.
“InnovaBurn is an innovative advancement in ECM technology for patients with partial-thickness, second-degree burns,” said Debra Noble, sales director of Convatec’s US Burn Division. “InnovaBurn allows burn patients the benefits of the latest and best placental ECM technology. Our unique source material helps us to manufacture some of the largest ECM sizes in the industry much more affordably, so more patients have access to this brand-new technology.”
Indicated for the management of wounds, InnovaBurn is a xenograft controlled for genetic variability and environmental and lifestyle factors, including diet and activity levels.
The device also can be used on traumatic lacerations, dehisced incisional wounds, pressure and venous ulcers, post-Mohs surgical wounds, post-surgical incisions, and diabetic ulcers.
InnovaBurn requires no preparation, specific placement orientation, tissue tracking, or special storage. It conforms and adheres to the wound site.
Convatec’s proprietary TriCleanse Placental Extracellular Matrix Process thoroughly decellularizes the ECM, disinfects the tissue, and deactivates viruses while maintaining the ECM’s structural proteins that can help heal. It creates a clean, efficient matrix for host cells to bridge across and remodel the defect.
InnovaBurn was cleared by the FDA through the 510(k) medical device pathway. FDA-cleared devices undergo rigorous review.
Photo courtesy of Convatec