Resected tissue was sent for pathological review and a pathologist blinded to the treatment assignment reviewed all tissue and provided grading on the degree of thermal artifact
based in the percentage of affected tissue (Grade I: 0%, Grade II: <25%, Grade III: 25% to 50%, Grade IV: 50% to 75% and Grade V: >75%).
Initial reports from our clinical trial sites indicate that there is virtually zero thermal artifact
on pathology slides made from specimens retrieved from the Intact Advance wand, making our percutaneous specimens of a similar quality to a surgical biopsy.
Spoon said, "The Company believes that the bipolar system is the first major advancement in the procedure marketed in over eight years and offers several advantages over current monopolar systems including: improved safety; lower procedure cost; and the potential for reduced thermal artifact
of tissue, allowing for improved diagnosis of tissue samples.
False variation in readings can be caused by thermal artifacts
that result from air drafts, patient positioning or movement, medical treatments, variation in haired or feathered areas, or other exogenous causes of warm and cool zones.
The thermal artifacts
are removed using conventional machining.