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The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008 (under K063723). The predicate device, the IMPELLA 2.5, and the Impella 2,5 Plus have identical designs and materials of construction. The only design modifications made to the IMPELLA 2.5 for the Impella 2.5 Plus are slight increases in the diameters of the inflow can ula impeller and pump housing (from 12 F to 14 F). As a result of this increase, the Impella 2.5 Plus has approximately 30% higher flow than the IMPELLA 2.5.

The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments. The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller with Flow Control is identical to the IMPELLA Controller in its physical characteristics. The only difference is that an additional operating mode. Flow Control Mode, has been implemented via a software modification. Both the IMPELLA Controller and the IMPELLA Controller with Flow Control are identical microprocessor-based pump motor drivers incorporating an infusion system. They both are intended to be used by trained healthcare professionals in hospital and medical transport environments.

The IMPELLA Controller is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments. The IMPELLA Controller also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller is a microprocessor-based pump motor driver and purge system. It is designed to operate on AC current (110-240 VAC, 47-63 Hz) or on an internal, rechargeable battery. The IMPELLA Controller generates the signals required to power the drive motor of one of ABIOMED's IMPELLA Percutaneous Support Catheters (the IMPELLA RECOVER LP 2.5 (cleared under K063723), the IMPELLA 5.0 LP and the IMPELLA 5.0 LD (cleared under K083111). The IMPELLA Controller also serves to deliver an infusate of the catheter's drive motor, and to provide useful information regarding the catheter's performance. It is intended to be used by trained healthcare professionals in hospital and medical transport environments. It is lightweight, portable and has an accompanying cart for ease of transport within the hospital.

The IMPELLA 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.

The IMPELLA 5.0 catheter family (IMPELLA 5.0) is an extension of the IMPELLA Percutaneous Cardiac Support product line. The IMPELLA 5.0 is capable of providing up to 5 liters per minute blood flow. The IMPELLA 5.0 are catheter based pumps intended for placement in the left ventricle. There are currently two versions of IMPELLA 5.0 Catheters, one inserted through the femoral artery via cutdown (the IMPELLA 5.0 LP) and the other through the aorta (the IMPELLA 5.0 LD). The only difference between the two versions is the shape of the inflow cannula. The IMPELLA 5.0 catheters provide a means for temporary extracorporeal circulatory support that returns blood to the patient's systemic circulation. Each IMPELLA 5.0 Catheter runs as a system comprised of: 1) a catheter which contains an integrated pump motor/ infusate lumen, integrated intravascular pressure sensor and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.

The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.

The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System) provides circulatory support with the ability to deliver anticoagulant through an infusion system. The System is comprised of: 1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure lumen and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.

The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle. Indications for Use: Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from: - Unstable refractory angina . - Impending infarction ● - Post Infarction Angina or Threatening Extension of Myocardial Infarction . - Refractory ventricular failure . - Mechanical complications because of myocardial infarction ● - Cardiogenic shock . - Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures - Ischemic related intractable ventricular arrhythmias . - Septic shock . - Interoperative pulsatile flow generation - Weaning from cardiopulmonary bypass . - Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients - Prophylactic support in preparation for cardiac surgery . - . Post-surgical myocardial dysfunction - Cardiac Contusion . - Mechanical bridge to other assist devices ● - Cardiac support following correction of anatomical defects ● - Support for failed angioplasty and valvuloplasty

The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases. The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters.

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: - . Unstable refractory angina - Impending infarction . - Post Infarction Angina or Threatening Extension of Myocardial . Infarction - Refractory ventricular failure . - Mechanical complications because of myocardial infarction - Cardiogenic shock . - Support and stabilization of high risk patients undergoing . diagnostic and non-surgical procedures - Ischemic related intractable ventricular arrhythmias . - Septic shock . - Interoperative pulsatile flow generation . - Weaning from cardiopulmonary bypass . - Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients - Prophylactic support in preparation for cardiac surgery . - Post-surgical myocardial dysfunction . - . Cardiac Contusion - . Mechanical bridge to other assist devices - . Cardiac support following correction of anatomical defects - Support for failed angioplasty and valvuloplasty .

The SupraCor Balloon Catheter is a 40cc symmetrical polyurethane balloon attached to an 8 Fr dual lumen catheter, designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon, and the inner lumen is used for a guidewire and blood pressure measurement. The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.