FDA Clears InspireMD’s CGuard Prime for U.S. TCAR Procedures

The Food and Drug Administration approved the device for transcarotid arterial revascularization, or TCAR, procedures, InspireMD said Thursday. The company expects the expanded use to roughly double its total addressable market in the U.S.

CGuard Prime treats carotid artery stenosis, a narrowing of the arteries, to reduce the risk of stroke. The new indication allows its use in minimally invasive procedures for artery disease. InspireMD expects to begin U.S. sales in the current fourth quarter.

To lead the U.S. launch, the company appointed Kathleen Kennedy as senior vice president of global sales and marketing. Chief Executive Marvin Slosman called the FDA approval for TCAR procedures a “transformative milestone” for InspireMD.

Separately, InspireMD commenced a proposed public offering.