The safety of AngioDynamics Inc.’s (NSDQ:ANGO) NanoKnife cancer-treatment device is being questioned by surgeons.
The NanoKnife technology, which was developed at the University of California, Berkeley, and licensed to AngioDynamics acquisition Oncobionics, was given FDA 510(k) clearance in 2008 for the treatment of heart ailments. Although it’s legal for physicians to use the device to treat other conditions, some doctors are questioning the risks associated with using the NanoKnife to treat cancer.
“There is growing concern in the interventional oncology community [that the NanoKnife] is being widely adopted prior to having gone through the necessary rigors of controlled investigations and clinical trials,” Northwestern Memorial Hospital chief of interventional oncology Riad Salem told the Wall Street Journal.
The NanoKnife uses so-called irreversible electroporation (PDF) surgical ablation technique in which "electrical fields are used to create nano-scale defects in a cell’s membrane." The pulses cause "cell death only in targeted tissue, while critical structures such as ducts, blood vessels and nerves remain functional," according to Queensbury, N.Y.-based AngioDynamics.
The device was first used to treat lung lesions and a lymph node metastasis in late 2008 by doctors in Melbourne, Australia. Dr. Ken Thompson, who performed the first procedures using the device, reported that the device triggered tachycardia, a fast heart rate, in four of 36 patients. The FDA reported a similar incident in early 2010. AngioDynamics said the cases were all treatable and that it has take steps to minimize the risk in its device. In July, a patient suffered chest bleeding after being treated with the NanoKnife that was severe enough to keep them in the hospital for 16 days, according to the Journal.
