Osprey gets FDA clearance for second-gen AVERT

Osprey Medical (ASX:OSP) has won US FDA approval for its second-generation AVERT system, a re-usable contrast modulator for the controlled infusion of dye during cardiac procedures.

With the product receiving FDA 510(k) clearance, Osprey now expects imminent sales of the system in Texas, where a number of hospitals are already routinely using the first-generation system.

Osprey CEO Mike McCormick said the second-generation version incorporates “a number of ease-of-use features that allow hospitals to use the AVERT without the need for Osprey support staff at each case”.

Osprey plans to use the Texas market to show the commercial potential, uptake and usage patterns of the product prior to a full US rollout.

McCormick said the company is now enrolling patients for a post-marketing study seeking to reinforce the company’s claim that AVERT can reduce the risk of contrast induced nephropathy (CIN), a type of kidney damage caused by exposure to the dyes used to assist with heart procedures.

AVERT is designed to cut down on the amount of dye injected during heart procedures, reducing the load that makes it to the kidneys.

Data from the trial will be used to submit an expanded CIN reduction marketing claim to the US FDA, and if the agency clears the claim the company will commence full US commercialisation in the second half of 2015, McCormick said.

Osprey Medical (ASX:OSP) shares were trading 1.19% lower at $0.083 as of around 1.30 pm on Tuesday.