Medtronic files for new approval of IN.PACT Admiral balloon

Medtronic has submitted its first pre-market approval module to the US Food and Drug Administration for the IN.PACT Admiral drug-eluting balloon.

The device is designed to treat atherosclerotic lesions in the superficial femoral artery and remains limited to investigational use in the US, though the company is hoping to be able to launch the product in this territory during the second half of 2015.

Several IN.PACT drug-eluting balloons received European CE Mark approval in 2008 and 2009 and are available in many countries around the world.

An ongoing global clinical study programme for the balloons for the treatment of peripheral arterial disease in the lower extremities has included 24 studies involving more than 4,200 patients at approximately 230 sites worldwide to date.

Tony Semedo, president of Medtronic's endovascular therapies business, said: "We will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology."

This comes after the firm announced the launch and first implantations of its RestoreSensor SureScan MRI neurostimulation system earlier this month.