FDA Clears Convatec’s Particulate Placental Extracellular Matrix

Convatec has received U.S. Food and Drug Administration (FDA) clearance for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.
 
According to the company, the newly-cleared product is the first and only next-gen placental-derived medical device designed to manage complex surgical wounds, chronic stalled wounds, and burns. It offers a placental-derived particulate product to replace human particulate placenta products no longer on the market.
 
“Convatec is always proud to bring healing innovations to patients with hard-to-heal wounds,” David Shepherd, president and chief operating officer of Advanced Wound Care at Convatec, told the press. “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 to manage wounds, including full- and partial-thickness wounds, surgical wounds, and traumatic wounds. The xenograft has been controlled for genetic variability and environmental and lifestyle factors likediet and activity levels. It 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.
 
It requires no prep, tissue tracking, or special storage.
 
“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 made with Convatec’s TriCleanse Placental Extracellular Matrix Process, which thoroughly decellularizes the ECM, disinfects the tissue, and deactivates viruses while maintaining structural proteins that help with healing. This creates a clean, efficient matrix for host cells to bridge across and remodel the defect.