Convatec today announced it has received clearance from the U.S. Food and Drug Administration for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.
The medical device joins Convatec's existing InnovaMatrix AC product as the first and only next-generation placental-derived medical devices designed for management of complex surgical wounds, chronic stalled wounds and burns. It gives physicians a placental-derived particulate product that can replace the human particulate placenta products no longer on the market. The product is commercially available.
"Convatec is always proud to bring healing innovations to patients with hard-to-heal wounds," said David Shepherd, President and Chief Operating Officer of Advanced Wound Care at Convatec. "We're pleased to offer physicians this new particulate product that is the first of its kind. It gives physicians a new, important tool for healing hard-to-heal wounds, continuing our efforts to expand the InnovaMatrix platform as part of our 'forever caring' promise."
InnovaMatrix PD is indicated for the management of wounds, including full- and partial-thickness wounds, surgical wounds and traumatic wounds. It is a xenograft that has been controlled for genetic variability and environmental and lifestyle factors, such as diet and activity levels. The device can be used to treat traumatic lacerations, dehisced incisional wounds, pressure and venous ulcers, post-Mohs surgery wounds, partial thickness burns, post-surgical incisions and diabetic foot ulcers.
InnovaMatrix PD requires no preparation, no tissue tracking and no special storage. It offers the inherent benefits of the placenta plus the quality control, reliability and safety profile of a medical device.
"This new, first-of-its-kind medical device was cleared by the FDA through the 510(k) pathway, meaning it passed very rigorous review," said Divakar Ramakrishnan, Chief Technology Officer at Convatec. "It's just one example of Convatec's commitment to bringing patients innovative products of the highest quality. Physicians tell us they are excited to have a particulate placental-derived product that can support the healing process for patients with complicated wounds."
InnovaMatrix products are manufactured with Convatec's proprietary TriCleanse Placental Extracellular Matrix Process, which thoroughly decellularizes the ECM, disinfects the tissue and deactivates viruses while maintaining its structural proteins that help with healing. This creates a clean, efficient matrix for host cells to bridge across and remodel the defect.
Medical devices are products that are reviewed by the FDA and meet specific criteria via the 510(k) or Premarket Approval pathway. FDA-cleared devices undergo rigorous review.