bio-ConneKt® Wound Matrix (Q4161)

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Key Features & Benefits:

• Composed of reconstituted Type I collagen derived from equine tendon, chemically crosslinked to resist early proteolytic degradation.  
• Sterile, conformable, porous, hydrophilic scaffold that can absorb fluids (≈0.5 cc per cm²) and conform closely to wound beds.  
• Stabilized collagen matrix allows the product to remain intact longer, reducing the need for frequent reapplications.  
• Room-temperature storage (dry), no need for refrigeration. Long shelf life.  
• Minimal preparation: hydrated in sterile saline before application, ready to use.  
• Biocompatible and cell-friendly; designed to integrate with host tissue over time (gradual remodeling) while supporting new tissue growth.

Indications / Use Cases:

bio-ConneKt is intended for managing moderately to heavily exuding wounds. 

It is used in a broad spectrum of wound types, including:

• Partial and full thickness wounds.
• Draining and tunneling wounds.
• Pressure ulcers, venous ulcers, chronic vascular ulcers.
• Diabetic ulcers.
• Traumatic wounds (abrasions, lacerations, partial thickness burns, skin tears).
• Surgical wounds (donor sites, transplant/graft sites, post-laser / Mohs surgery, dehisced incisions).

Mechanism / Performance:

• As a porous collagen scaffold, bio-ConneKt facilitates host cell infiltration, allows nutrient / oxygen diffusion, and serves as a temporary framework for cellular ingrowth.  
• The crosslinking reduces proteolytic breakdown in the wound environment, preserving structural integrity during early healing.  
• Over time, the dressing becomes incorporated and replaced by the body’s own collagen, leaving regenerated tissue.  

Contraindications / Warnings:

• Not for use in patients with known hypersensitivity to equine-derived collagen.  
• Should not be applied to actively infected or untreated wounds until infection is controlled.  
• Not designed for third-degree burns.  
• Single use only; product cannot be re-sterilized.  

Application / Handling Instructions:

1. Inspect the sterile pouch; use only if intact.
2. Open the inner pouch in a sterile field, remove the dry matrix and place in sterile saline (or 0.9% sterile saline) for ~2 minutes to rehydrate.  
3. Trim to slightly larger than wound size; overlapping for adjacent pieces if needed.
4. Place the rehydrated matrix onto the wound, ensuring full contact (avoid folds).
5. Cover with an appropriate non-adherent secondary dressing to maintain a moist environment.
6. Monitor and change secondary dressing as needed; do not forcibly remove the bio-ConneKt if it adheres.  

Regulatory / Reimbursement:

• The product is FDA cleared under 510(k) (K140456) as a collagen wound dressing.  
• Assigned HCPCS code Q4161 for billing / reimbursement.