Convatec technology is only medical device
of its kind
MEMPHIS,
Tenn., March 2, 2023 /PRNewswire/ -- Convatec has
received clearance from the U.S. Food and Drug Administration for
its InnovaBurn® placental extracellular matrix medical device
for management of complex surgical wounds and burns, including
partial-thickness second-degree burns.
FDA clears first placental extracellular
matrix medical device for management of second-degree burns
Each year, almost 500,000 people seek medical treatment for burn
injuries, according to the American Burn Association's
ameriburn.org, which cites the most recent estimates available from
the Centers for Disease Control and Prevention. Of these patients,
about 40,000 were hospitalized for their burn injuries.
The InnovaBurn® medical device joins Convatec's
InnovaMatrix® platform as the first and only placental-derived
medical devices designed for management of 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 U.S. 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. Physicians
tell us they appreciate the special sizing and
InnovaBurn's ease of use that help them manage larger wounds
like burns."
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, no specific placement
orientation, no tissue tracking and no special storage. It conforms
and adheres to the wound site.
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 the ECM's
structural proteins that can help with healing. This 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. 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. InnovaBurn® joins the InnovaMatrix® product
family, which also includes the InnovaMatrix® AC placental ECM
device that is available in several sizes; InnovaMatrix® FS,
the fenestrated form designed for wounds with heavy exudate;
and InnovaMatrix® PD, the particulate form.
Convatec's 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.
MKT-2022-0152E V01
AP-60801-USA-ENGU-v1 (v1.1)
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SOURCE ConvaTec