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The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has a clear medical grade polyurethane window and bulb that facilitates visualization of the puncture site, a clear medical grade PVC flexible tube, and a pressure sensitive, self-adhesive peel backing. A luer valve on the end of the fill tube enables a luer lock syringe to be connected to inflate and deflate the bulb with air to provide compression of the transradial puncture site.

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use: - Refractory Unstable Angina. - Impending Infarction. . - Acute Myocardial Infarction. . - Refractory Ventricular Failure. . - Complications of Acute MI (ie. Acute MR or VSD or papillary . muscle rupture) - · Cardiogenic Shock. - Support for diagnostic, percutaneous revascularization and . interventional procedures. - Ischemia related intractable ventricular arrhythmias. . - . Septic Shock. - Intraoperative pulsatile flow generation. . - Weaning from cardiopulmonary bypass. . - Cardiac support for non-cardiac surgery. . - Prophylactic support in preparation for cardiac surgery. . - . Post-surgical myocardial dysfunction/low cardiac output syndrome. - Myocardial Contusion. . - Mechanical bridge to other assist devices. - Cardiac support following correction of anatomical defects

The SENSATION PLUS™ 7.5 Fr. 40cc IAB Catheter is an enhanced MEGA® 7.5Fr IAB Catheter (K120868) device which includes a catheter, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change - the stylet wire (a packaging component) was removed. The SENSATION PLUS™ 7.5Fr. 40cc Insertion kit contains the same components as currently used with the MEGA® 7.5Fr 40cc IAB Catheter (K120868), with the sole exception that the SENSATION PLUS™ 7.5Fr. 40cc Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION PLUS™ 8Fr. 50cc Insertion Kit (K112327). The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the Intra-Aortic Balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to. the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpuisation. This is the same intended use as other IAB Catheters.

Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters. The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: - Refractory unstable angina - Impending infarction - Acute MI - Refractory ventricular failure - Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) - Cardiogenic shock - Support for diagnostic, percutaneous revascularization, and interventional procedures. - Ischemia related intractable ventricular arrhythmias ● - Septic shock - Intraoperative pulsatile flow generation - Weaning from bypass - Cardiac support for non-cardiac surgery - Prophylactic support in preparation for cardiac surgery - Post surgical myocardial dysfunction/low cardiac output syndrome - Myocardial contusion - Mechanical bridge to other assist devices - Cardiac support following correction of anatomical defects

Datascope's 8Fr. 50cc Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. The modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.