Minneapolis, Minn.(June 25, 2016) – In accordance with Health Canada Medical Devices Regulations, Section 36, Arobella Medical, LLC issued Medical Device Licence (Class 2 MDL LN97205) for the Qoustic Wound Therapy System™ platform, its variants and accessories.
This licence represents another major milestone for Arobella Medical’s passionate pursuit to advance the standard of care when it comes to treating and healing wounds.
Eliaz Babaev, CEO and President of Arobella Medical, LLC, “Currently in negotiations with several distributors, we are trying to bring this technology all across Canada and all the various provinces.”
He added, “We are glad we can finally bring this improved standard of care to current wound care practices and facilities and offer another tool to improve the quality of life for patients with a wide variety of chronic and other types of troublesome wounds.”
The Qoustic Wound Therapy System™, Model AR1000 Series and its variants had previously received, under FDA 510(k) clearance (K131096), new and expanded claims and indications for use, as indicated below:
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, 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)1
We are very excited at what this represents in the advancement of wound care, improved treatment methodologies and trajectories, and better patient compliance and outcomes.