Arobella Wound Therapy System

The Qoustic Wound Therapy System™, patented and patent pending, uses ultrasonic energy for the selective dissection and fragmentation of tissues, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing saline irrigation of the site for the removal of debris, exudates, fragments, and other matter. Not only does the Qoustic Wound Therapy System™ provide a superior debriding process, but it also allows for more control over the procedure. The unique domed shape of the Qoustic Qurette™ significantly advances state-of-the-art technology by permitting controlled volumetric removal of unwanted tissue while focusing ultrasonic energy directly on the area of the wound being treated.

The Qoustic Wound Therapy System™ allows:

• Selective, precise, and gentle fragmentation of soft and hard tissues
• Preservation of healthy tissue through ultrasonic separation of damaged tissue
• Cleansing of the wound area with less pressure and pain
• Reduction of splash created by residuals of sharp debridement and saline wash
• Improvement in granulation of treated tissue
• Stable delivery of ultrasound energy during procedure

This process is directed for single (1) treatment, and total recommended treatment shall be no more than three (3) times per week; typically treatment regimen is approximately two (2) weeks or more, depending on the size and nature/condition of the treated area as well as other subject dependent factors, but may be prescribed longer on the order of a physician. 

• This product has been cleared by the FDA for sale in the United States. Cleared indications for use (K062544)
  • Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.
• This product has been cleared by the FDA for sale in the United States. Cleared indications for use (K131096)
  • Selective and non-selective dissection and fragmentation of soft and/or hard tissue
  • Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter
  • Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue)
  • Contact and/or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter
  • Preparing the wound bed for graft or other subsequent procedures using contact and/or non-contact techniques to achieve wound debridement
  • It is prescribed for patient population of any age with one or more wounds and/or that may also exhibit Diabetes Mellitus (DM)
• Ideal for:
  • Wound Management
  • Treating specific types of wounds including:
    • Diabetic foot ulcers
    • Pressure ulcers
    • Venous Insufficiency Ulcers
    • Arterial Wounds
    • Compromised Surgical Wounds
    • Burns
    • Osteomyelitis
    • Fistulas
    • Infected, Eczematous, Ulcerated or Devitalized Skin

The Qoustic Wound Therapy System™ can be used with the following irrigation (lavage) fluids:

• Sterile 0.9% saline (which is widely available for purchase from medical suppliers)
• Sterile de-ionized water
• Vashe™ Wound Cleanser solution (which is produced from PuriCore’s Vashe™ Generator)
• Other solutions approved for wound therapy or debridement

• Generator power source: 90-264~, 2.5A, 50-60Hz
• Converter Power Output: <140 watts
• Amplitude: 0 – 75 μm
• Frequency: 35kHz (±2kHz)
• Storage Temperature: -20 to 50°C at a maximum relative humidity of 90% (non-condensing)
• Operating Temperature: 0 to 40°C at a maximum relative humidity of 90% (non-condensing)
• Weight:
  Generator: 13.5 lbs (6.1kg) [AR1000B];
  Handheld Applicator: 13.5 oz (0.4kg) [AR1000] / 11.5 oz (0.3kg) [AR1000D]
• Dimensions:
  Generator: 15.50 in (W) x 14.25 in (D) x 5.25 in (H);
  Handheld Applicator: 9 in x 1.4 in (Ø)

The Qoustic Wound Therapy System™ is indicated for producing and delivering low frequency ultrasound used to promote wound healing via: 

• Selective and non-selective dissection and fragmentation of soft and/or hard tissue 
• Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, brin, tissue exudates, bacteria and other matter 
• Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) 
• Contact and/or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, brin, excised or fragmented tissue, and other matter 
• Preparing the wound bed for graft or other subsequent procedures using contact and/or non-contact techniques to achieve wound debridement Medical Billing Codes for QWTS Surgical Debridement 

It is prescribed for patient population of any age with one or more wounds and/or that may also exhibit Diabetes Mellitus (DM).*

*FDA 510(k) clearances K062544, dated January 3, 2007 and revised July 2, 2009, and K131096, dated May 16, 2014.