Soft K-Biopsy® – SFT-1000
SoftBiopsy® is a sterile single-use brush-curette is designed to be both minimally invasive and clinically effective for tissue sampling. The plastic applicator tip is coated with Kylon®, a patented medical fabric which dislodges and collects wound base tissue post-debridement, efficiently and effectively.
The SoftBiopsy® is designed with a trumpet shaped brush tip to easily press into the wound base surface and remove and trap a biopsy sample for anatomic pathology as curettings (tangential biopsy sample). When used post-debridement, it is optimal for molecular (PCR) or microbiological culture.
Organism ID Sampling Method
Once the biopsy is obtained, tissue samples for analysis are easily collected in the KYLON® hook tapered tip head and snapped off and placed into the vial to preserve tissue for organism (culture, PCR) or anatomic pathology lab analysis.
Request that your pathology lab that performs wound related tests contact us to become a Kylon® device “Center of Excellence”.
Benefits:
- Fabric pad on tapered applicator tip is designed for visible surface wounds that are visible on the body surface
- Versatile use, Ergonomic, and minimally invasive design facilitates user tactile control for targeting and guiding the brushing, sweeping and rotational movements – modulating tactile pressure and method allows for tissue. removal and trapping using a pressure-twisting motion of the wound surface
- Kylon® medical fabric hooks gently, yet substantially obtain abundant tissue samples that are trapped in the hook array, snapped free from the handle, and transported for laboratory analysis
- Designed for compassionate patient experience and compliance
Clinical Scenarios: (Refer to Instructions for Use)
The SoftBiopsy® is indicated for tangential biopsy of wounds on visual surfaces in order to obtain a sterile biopsy sample. Once the tissue filled tip is detached and placed in a vial, it is transported for histological analyses and further laboratory evaluation regarding infection or other pathology
Contraindications:
SoftBiopsy® is contraindicated for use with patients with known bleeding disorders or those on anticoagulant therapy, patients with an acute wound infection or condition that is not amenable to biopsy, patients with a known allergy to nylon or acrylic plastic, or patients who are pregnant or suspected to be pregnant when a wound biopsy would not be indicated
Warnings and Precautions:
Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.
Storage Requirements:
Consult manufacturer on special storage requirements outside of normal room temperatures.
How Supplied/Sizing:
Box of 25 minimum order
Recommended Use:
- Burns
- Chronic Wounds
- Diabetic Foot
- Graft Bed Preparation
- Non/Minimally Exudating Wounds
- Palliative Wounds
- Pressure Ulcers
- Non-Eschar/Solid/Fibrotic Wounds
- Sloughy Wounds
- Surgical Wounds
- Venous Ulcers
Mode of Use/Application:
See manufacturer’s website for detailed instructions for use (IFU)
Clinically Tested:
Latex-friendly
Product features:
- Single Use
- Disposable
- Instrument
- Sterile
Other features:
- Educational Material Available
- Free Samples/Trials Available
- Published Clinical Study Available
Manufacturer: Histologics LLC – www.histologicswc.com
Histologics LLC’s primary objective is to advance a compassionate approach to debridement and wound biopsy sampling with devices using Kylon®, a medical fabric enabling biopsy with tissue capture, or frictional tissue cleaning, and debridement.
Website:
Email:
Phone:
(888) 235-2275
Toll-free:
(888) 235-2275
Fax:
(888) 738-9757