Convatec has secured clearance from the US Food and Drug Administration (FDA) for its InnovaMatrix PD particulate placental extracellular matrix medical device for the management of wounds.
The next-generation placental-derived medical device has been created for the management of complex surgical wounds, chronic stalled wounds, burns, traumatic wounds, and full- and partial-thickness wounds.
Convatec said that the InnovaMatrix PD joins its current InnovaMatrix AC product, which is designed for acute, traumatic, and hard-to-heal wound management.
Available commercially, the InnovaMatrix PD device provides doctors with a human placenta-derived particulate product to replace the human placenta particulate products that are no longer available in the market.
Convatec advanced wound care president and COO David Shepherd said: “Convatec is always proud to bring healing innovations to patients with hard-to-heal wounds.
“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 said to be a xenograft that has been controlled for genetic variabilities and environmental and lifestyle factors like diet and activity levels.
As per the medical device firm, the device can treat traumatic lacerations, pressure and venous ulcers, dehisced incisional wounds, post-Mohs surgery wounds, partial thickness burns, diabetic foot ulcers, and post-surgical incisions.
Additionally, InnovaMatrix PD provides the natural advantages of the placenta along with the quality assurance, dependability, and safety features of a medical device. It requires no specific preparation, tracking, or storage, said the company.
Convatec chief technology officer Divakar Ramakrishnan said: “This new, first-of-its-kind medical device was cleared by the FDA through the 510(k) pathway, meaning it passed very rigorous review.
“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.”
The InnovaMatrix products are made using the proprietary TriCleanse Placental Extracellular Matrix Process.
