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The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The CentriMag™ Blood pump for use with CentriMag™ Acute Circulatory Support System (hereafter referred to as the CentriMag System) is designed to provide assisted extracorporeal circulation and physiologic gas exchange of patients' blood for adult patients with acute respiratory and/or acute cardiopulmonary failure. The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The system includes: CentriMag 2nd Generation Primary Console, CentriMag Motor, CentriMag Blood Pump, Flow Probe, and Mag Monitor (optional). The CentriMag System features a centrifugal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology). The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.) The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours. The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. The CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - Mag Monitor (optional) The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System. The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, single use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - Mag Monitor (optional, not shown) The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271). The Cannula Kit includes the following accessories: QTY | Kit Component ---|--- 1 | Return (Arterial) Cannula Body 1 | Connector, 3/8-inch, barbed 1 | Introducer 1 | Hemostasis Seal 1 | Cap (with Umbilical tape) 1 | Porous Plug 1 | Guidewire Assembly 1 | Introducer Needle 4 | Suture Rings (small) 4 | Suture Rings (medium) 4 | Tip Rings

The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271). The Drainage Cannula Kit includes the following accessories: QTY Kit Component 1 Drainage (Venous) Cannula Body 1 Connector, 3/8-inch, barbed 1 Apical Sewing Ring with Umbilical Tape 1 Apical Sewing Ring Handle 1 Cap (with Umbilical Tape) 1 Apical Support Cuff 4 Suture Rings (large) 4 Suture Rings (medium)

The 2nd Generation CentriMag Primary Console and Mag Monitor are indicated for use with the CentriMag Extracorporeal Blood Pumping System. The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Mag Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Mag Monitor: however it can be also operated as a stand-alone unit. The Mag Monitor provides a redundant user interface containing a display and touch pads. The Mag Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console. The Mag Monitor is a 12V DC-powered device and receives its power directly from 200 Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Mag Monitor cannot be plugged into a hospital AC power outlet. The Mag Monitor's core function is to provide multi-color alphanumerical and graphical displays of information it receives from the 200 Generation CentriMag Primary Console. The Mag Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Monitor. The Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Mag Monitor is connected to the 200 Generation CentriMag Primary Console through one cable, which includes data and power lines. Power is provided by the 200 Generation CentriMag Primary Console. The redesigned Mag Monitor is compatible with both the current 200 Generation Console and the redesigned 2nd Generation Console. However, when plugged into the current Console, the redesigned Mag Monitor will only operate when the Console is connected to AC power. It will not operate when the current Console is run on Battery power