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The AC3™ Range ™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: - 1. Acute Coronary Syndrome - 2. Cardiac and Non-Cardiac Surgery - 3. Complications of Heart Failure

The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The AC3 Range IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels for easy transport. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.

The AC3™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: - 1. Acute Coronary Syndrome - 2. Cardiac and Non-Cardiac Surgery - 3. Complications of Heart Failure

The AC3™ Series Intra-Aortic Balloon Pump (IABP) system is a professional use device that provides counterpulsation therapy to adult patients with impaired Left Ventricular (LV) Function. The AC3 Series IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.

The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) arc clinically indicated for use for the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

The AutoCAT Series IABP System, including the AutoCAT®2 and AC3™ Series IABP's, provide counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. They provide hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB. increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand. The AutoCAT Series IABP Systems consists of two main components: - The pump control/display module which incorporates a touch screen and keypad for . system operation, and - . The pneumatic drive module which is incorporated into the body of the device The AutoCAT Series IABP are designed to be used with 30, 40 and 50cc IAB catheters with the appropriate connectors. The primary difference between the AutoCAT®2 IABP and AC3TM series IABP is the user interface, where the display is a touchscreen.

The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon. The FiberOptix® IAB Catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface. The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The AC3™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: - · Acute Coronary Syndrome - · Cardiac and Non-Cardiac Surgery - · Complications of Heart Failure

The AC3™ Series IABP System provides counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers Helium (HE) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand. The AC3™ Series IABP System consists of two main components: - . The pump control/display module which incorporates a touch screen and keypad for system operation, and - The pneumatic drive module which is incorporated into the body of the device ● The AC3™ Series IABP is designed to be used with 30, 35, 40 and 50cc Intra-aortic balloons with the appropriate connectors.

UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

The UltraFlex IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) regulates the inflation and deflation of the balloon. The UltraFlex IAB catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.

FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon. The FIBEROPTIX IAB consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface. The FIBEROPTIX IAB has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE IABP (Hybrid Model) 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 an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB 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 counterpulsation. This is the same intended use as other IABPs.

The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices. The IABP 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 an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB 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 counterpulsation.

The AC3TM Series IABP (Intra-Aortic Balloon Pump) System is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

The AC3 Series Intra-Aortic Balloon Pump (IABP) System, which is the subject of this submission, is substantially equivalent to the previously cleared Arrow AutoCAT®2 IABP System which was previously cleared via K060309. The AC3 Series IABP System is the next generation platform which is based on the existing AutoCAT2 IABP System; cleared Device via K060309 on 6 April 2006. The AC3 Series IABP System (AutoCAT3) includes a new Graphical User Interface. The primary algorithms that control the therapeutic function of the device have not been altered from the AutoCAT2. The AC3 Series IABP system provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an IAB (Intra-aortic Balloon) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers Helium (HE) into the IAB during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand. The AC3 Series IABP System consists of two main components: The pump control / display module which incorporates a touch screen and keypad for system operation The pneumatic drive module which is incorporated into the body of the device. The AC3 is designed to be used with 30, 35, 40, and 50cc Intra-Aortic Balloons with the appropriate connectors. (UltraFlex™, Ultra 80, NarrowFlex®, and RediGuard® Catheters). The system offers two modes of operation: Autopilot Mode, where most functions are automatically selected and controlled by the IABP Operator mode, where an operator can control most settings and selections.