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The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to provide external Counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The Cardiomedics CardiAssist External Counter Pulsation System - Series 4000 is a non-invasive circulatory assist device, which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist External Counter Pulsation System - Series 4000 consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral patient chart printer, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 5-lead ECG cable and leads (12 lead optional) and blood pressure cuff. This CardiAssist ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels, which increases the driving pressure in the coronary vasculature.

The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

The CardioMedics CardiAssist™ ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, angina pectoris, myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads. This CardiAssist™ ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The CardioMedics, Inc., CardiAssist CounterPulsation System is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

The CardioMedics CardiAssist ECP System is a non-invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads. This CardiAssist ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature. The difference between the new device and the predicate device is the indication. The indication is being expanded to include the treatment of congestive heart failure patients. The treatment of congestive heart failure patients with the CardiAssist ECP System does not require any changes in software, device design, or treatment regimen. The treatment of this patient population does not significantly change the safety or effectiveness of the device.

The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

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