FDA closes out AngioDynamics NanoKnife warning letter

AngioDynamics (NSDQ:ANGO) said today it received a notice from the FDA closing out a warning letter it received in January 2011 in relation to its NanoKnife system.

The Albany, N.Y.-based company’s NanoKnife system uses high-voltage, low-energy electrical pulses which AngioDynamics said can permanently open pores in cell membranes.

The company received a warning in 2011 over allegedly over-zealous marketing of the NanoKnife system. The FDA accused AngioDynamics of making statements on its website promoting the use of the device beyond its approved indications.

Though the company did not state what the original compliance issues, it said it began shipping the devices in April 2012 after removing the Ablation Zone Estimator feature, saying the move was “pursuant to previously announced voluntary actions.”

“Over the past 4 years we have worked diligently to improve our quality and compliance systems, including product design, manufacturing and marketing. I am very proud of our team’s progress and this milestone is further evidence of our ongoing commitment to quality and compliance. Closing out the January 2011 Warning Letter related to NanoKnife marketing activities is another positive step in our commercialization of NanoKnife. Along with the Certificates to Foreign Governments that we attained at all our facilities earlier this year, we look to maintain our high quality standards as we build our business worldwide,”CEO Joseph DeVivo said in a press release.

In October, AngioDynamics said it won approval from South Korea’s Ministry of Food and Drug Safety for its NanoKnife system designed to ablate soft tissue.

The company said its NanoKnife has been approved in Malaysia, South Korea, Thailand and Vietnam in the past 60 days. The device has also won approval in China and has been cleared by the FDA.

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