FDA clears first particulate placental extracellular matrix medical device for wound management

Rhea-AI Summary

Convatec has received FDA clearance for its InnovaMatrix® PD particulate placental extracellular matrix medical device, marking it as the first of its kind for wound management. This innovative device is designed specifically for managing complex surgical wounds, chronic stalled wounds, and burns. Joining Convatec's existing InnovaMatrix® AC product, it provides physicians with a reliable tool that replaces older human-derived products no longer available. The device requires no preparation or special storage, leveraging Convatec's TriCleanse™ technology for enhanced safety and effectiveness in healing.

Positive

• First FDA-cleared particulate placental ECM medical device for wound management, offering a new treatment option.
• Does not require preparation, tissue tracking, or special storage, enhancing usability for healthcare providers.
• Leverages proprietary TriCleanse™ technology, ensuring safety and efficacy.

Negative

• None.

Convatec product is only medical device of its kind

MEMPHIS, Tenn., Feb. 23, 2023 /PRNewswire/ -- 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.

FDA clears first-ever particulate placental ECM 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.

Convatec Advanced Tissue Technologies, formerly Triad Life Sciences, focuses on regenerative medicine and developing biologically derived innovative products to address unmet clinical needs in surgical wounds, chronic wounds and burns. Regenerative medicine and biologically derived therapies are frequently used to treat hard-to-heal wounds, which affect about 8.2 million Medicare patients each year in the U.S., according to Advances in Wound Care's May 2021 publication 'Human wound and its burden: Updated 2020 Compendium of Estimates.' Founded in 2017, Triad Life Sciences, based in Memphis, Tennessee, was acquired in 2022 by Convatec Group Plc.

For more information about InnovaMatrix^® products, visit www.triadls.com and follow on LinkedIn @ConvatecWound, on Twitter @ConvatecWoundUS and on Facebook @ConvatecInc.

Convatec Group Plc

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE:CTEC) and in 2021 revenues were over $2 billion. To learn more about Convatec, please visit http://www.convatecgroup.com. 

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SOURCE Convactec

FAQ

What is the significance of Convatec's InnovaMatrix® PD clearance by the FDA?

The FDA clearance signifies that Convatec's InnovaMatrix® PD is the first particulate placental extracellular matrix medical device for wound management, providing a new treatment option for complex surgical and chronic wounds.

When was Convatec's InnovaMatrix® PD device cleared by the FDA?

The InnovaMatrix® PD device was cleared by the FDA on February 23, 2023.

What conditions can the InnovaMatrix® PD device treat?

InnovaMatrix® PD is indicated for various wounds, including full- and partial-thickness wounds, surgical wounds, traumatic lacerations, ulcers, and burns.

What technology is used in the InnovaMatrix® PD device?

The device is manufactured using Convatec's proprietary TriCleanse™ technology, which decellularizes placental tissue and disinfects it while preserving essential structural proteins for healing.

Is the InnovaMatrix® PD device commercially available?

Yes, the InnovaMatrix® PD device is commercially available following its FDA clearance.