DevicePMAs@therightstef:P860019_S149 JSONTXT 11 Projects

Approval requested for the SCIMED REMEDY Coronary Balloon Dilatation Infusion Catheter . The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion , and to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atm. The REMEDY catheter (2.5 - 4.0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.