Angiodroid yanks 510(k) over FDA CO2 clearance issue

ADM Tronics Unlimited said last Friday Angiodroid Americas withdrew its FDA premarket notification 510(k) application for the Angiodroid CO2 injector for angiography over lack of clearance for CO2 related to the indication.

The Angiodroid device is an automatic injector for peripheral angiography that used CO2 gas which the company claims eliminates issues with iodine contrast medium that can be poorly tolerated by diabetic or nephropathy patients. The device also reduces the risks and pain associated with the manual injection of CO2.

Northvale, N.J.-based diagnostic and therapeutic med device company ADMT said CO2 gas has not been cleared by the FDA for the indication, and that it is currently researching what “would be required for CO2 gas to be approved for this use,” according to a press release.

The Angiodroid CO2 injector has approval in the European Union as well as markets in the Middle East and Asia, ADMT said.

ADMT owns 20% of Angiodroid America, a subsidiary set up to produce the device in the Americas in partnership with Triotech Ventures, the company said. Angiodroid America is a majority-owned subsidiary of Angiodroid, Srl, a privately owned Italian entity.

ADMT supplies engineering and regualtory services, as well as operates as the exclusive manufacturer of the device for the North American market, the company said.

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