Fibrillar Collagen Wound Dressing by Collagen Matrix Secures the Company Its 40th FDA 510(k) Clearance

Fibrillar Collagen Wound Dressing by Collagen Matrix Secures the Company Its 40th FDA 510(k) Clearance

Fibrillar Collagen Wound Dressing made from TruSource™ medical grade collagen. Photo courtesy of Collagen Matrix Inc.

Wound healing is an intricate process that involves multiple cell types such as chemokines, cytokines, fibroblasts, inflammatory cells and more. A wound healing process must sequentially undergo four stages which are hemostasis, inflammation, proliferation and remodeling. Wound healing may be delayed due to various factors such as age, obesity, diabetes, radiation therapy, infection at the wounded site, necrosis and others.

Some standard methods that augment wound healing are antimicrobial dressings, autolytic and chemical debridement, grafting and absorbent dressings for wounds that exudate.

Recent innovations have brought in many new procedures for wound healing such as hydrosurgery, plasma-mediated bipolar radio-frequency ablation therapy and the use of natural polymer materials such as chitosan, hyaluronic acid, gelatin and collagen.

Collagen is an abundant structural protein in animals. The pivotal role of collagen is for structural support of the extracellular space of connective tissue.

Collagen Matrix Inc., a leader in the development of collagen and other biomaterial-based medical devices for regenerative medicine, announced this week that the company received a 510(k) clearance from the US Food and Drug Administration (FDA) for their new Fibrillar Collagen Wound Dressing. This is the company’s 40th 510(k) clearance from the FDA.

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Collagen Matrix’s Fibrillar Collagen Wound Dressing — Principle and Design

The Fibrillar Collagen Wound Dressing is used to manage moderately to heavily exuding wounds and can also help control minor bleeding. The dressing is an absorbent microfibrillar collagen matrix that is applied directly to a wound bed to absorb the exudates from the wound and protect the wound bed and the delicate new tissue. The dressing can be used to manage venous stasis ulcers, pressure ulcers, diabetic ulcers, partial-thickness burns and acute wounds (such as trauma and surgical wounds).

The Fibrillar Collagen Wound Dressing by Collagen Matrix Inc. is available in different sizes and is non-pyrogenic, sterile and for single use only.

“This 40th 510(k) milestone is a testament to our team’s tireless commitment to developing meaningful innovation in regenerative medicine throughout our 25-year history. We’re excited to expand our portfolio into advanced wound care, a $9B global market with numerous opportunities for our technologies to make a difference for patients worldwide,” said Shawn McCarthy, CEO of Collagen Matrix, in the company’s press release.

“Significant unmet needs in this area demand more effective and proficient treatment of wounds of all types, especially chronic wounds, and with the synergies our technology platforms offer, Collagen Matrix is well positioned to gain approvals and commercialize products quickly with our partners in markets around the world,” added McCarthy.

The mission of Collagen Matrix is to “improve patients’ lives through the design, development and production of innovative regenerative implantable devices.” Since its founding in 1997, Collagen Matrix has introduced more than 75 products which have impacted more than 15 million patients in the world.

Non-Clinical Studies for Safety and Performance Evaluation

Several evaluation techniques were used to assess the safety and performance of Collagen Matrix’s Fibrillar Collagen Wound Dressing. These included tests published by the International Organization for Standardization (ISO) for the biological evaluation of medical devices: tests for in vitro cytotoxicity, tests for skin sensitization and tests for acute systemic toxicity. The US Pharmacopeia (USP) <151> Pyrogen test was also conducted. More sub-chronic toxicity testing of the predicate device was used to support the performance and safety of the subject device.

After testing the Fibrillar Collagen Wound Dressing with the above-mentioned methods, the product was found to be substantially similar to the legally marketed predicate device.