NanoKnife generator by AngioDynamics Inc.: ©AngioDynamicsA medical device called the NanoKnife by AngioDynamics, an innovator in the medical device field, is being questioned by members of the medical community because the device was fast-tracked by the Food and Drug Administration (FDA), and was approved without clinical studies in 2008. Essentially, the device went from animal testing straight to the market of hospital interventional radiologists and oncologists. But...
While more than 300 persons in the U.S. and other countries have had surgical removal of tumors via the NanoKnife, very few patients reporting side effects - mostly fast heartbeats. The side effects are treatable and usually only last for a day or two, and AngioDynamics took subsequent steps to minimize that side effect.
There was a more serious occurance; one patient experienced a serious artery puncture during his surgery, a complication that AngioDynamics reported is a possible complication of any similar surgery. The man was treated and survived.
The doctor who helped support the device's use, radiologist Gary Onik, treated about 30 cancer patients with the NanoKnife in 2008, and all but two patients are still cancer free. After all, the electronic surgical tool was developed to remove cancers that could not be successfully treated with other means; perhaps some of these patients might not even be alive today if no other means of treatment could succeed.
The NanoKnife system is a minimally invasive tissue ablation technology that uses a technology called irreversible electroporation (IRE), "a non-thermal ablation method designed for the precise, fast and effective ablation of soft tissue." (source) Electrical probes are inserted into the patient through the skin and the practitioner places the probes around the tumor, essentially shocking it to death. The whole procedure takes about four minutes with no cutting involved, and the healthy surrounding tissue is preserved. Patients are usually released from the hospital the same day.
Up to six NanoKnife electrodes can be used to surround and stabilize the tumor.: ©AngioDynamics, image via Wall Street Journal
The NanoKnife, which comes with an amazingly thorough 170-page user manual, including ways to minimize side effects from the procedure, is now used in 13 hospitals, and practitioners do not seem to be complaining about their results. If this technology is saving lives, it was a good thing that the FDA pushed the NanoKnife through the system. But maybe now, without denying current patients this cancer treatment with NanoKnife, AngioDynamics can conduct the appropriate clinical trials and report results to the FDA and the medical community.
For a fascinating visit with the NanoKnife, watch this YouTube video.
Wall Street Journal, Angiodynamics, NanoKnife User's Manual