FDA Clears New Ablation Technique
AngioDynamics, Inc. has announced FDA 510(k) clearance for Oncobionic, Inc. to market Irreversible Electroporation (IRE) — a technology approved for the surgical ablation of soft tissue, including cardiac and smooth muscle.
AngioDynamic’s acquisition of Oncobionic for a total of $25 million will be completed following successful human use of its IRE technology, testing that is expected to begin mid-year 2007.
Like thermal ablation, irreversible electroporation uses needles and image guidance, but instead of "cooking" or "freezing" the targeted tissue, IRE disrupts the cell membrane, thereby destroying the targeted cells, according to a Business Wire report. Needles electrodes placed through the skin by image guidance near the targeted tissue transmit an electrical field to create permanent nanoscale pores in cell membranes. These impaired cells are left for the body’s immune system to remove.
Possible advantages of IRE over radiofrequency and cryoablation include: faster delivery of ablation energy, clearly defined and predictable treatment margins and complete destruction of tissue adjacent to large vessels (no heat sink effect)
The IRE technology was invented at the University of California, Berkeley, by the group of Professor Boris Rubinsky, and is exclusively licensed to Oncobionic for commercial development within this field of use.