World’s First Subcutaneous Implantable Defibrillator Gets FDA Panel Vote

There was just enough doubt to make this one interesting, but now it’s been confirmed that the FDA’s Circulatory Devices Expert Panel has voted in favour of the world’s first subcutaneous defibrillator that doesn’t rely on intravascular leads to function, opening the door to subsequent FDA approval.

The panel reportedly voted 7/1 that the risks associated with Cameron Health’s S-ICD® device, as identified during the IDE study, were outweighed by the benefit of having a device deliver therapeutic energy to the heart without the need for intravascular leads.

For a full resume of the expert panel’s comments and findings, click here for coverage provided by theheart.org’s Reed Miller.

Full FDA approval for the device is likely to occur within the next 12 months, at which time a second tranche of money reported to be $150m will arrive at Cameron Health as part of its payout following acquisition by Boston Scientific as we reported back in March here.

Source: theheart.org