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The External Counterpulsation System, Soulaire device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The External Counterpulsation System, Soulaire device has similar design to the External Counterpulsation System Model ECP-MC3. The Soulaire system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastde begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

The OM-A device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

Enhanced External Counterpulsation Device Plus OM-A is a computer-controlled system that applies external pressure via cuffs to the patient's lower extremities in synchronization with the patient's cardiac cycle. When the heart is in its relaxed state (diastole), pressure is applied sequentially; distal to proximal, from the lower legs (calves) to the lower thighs and then the upper thighs and buttocks, to propel blood back to the heart. The consequence is an increase in arterial blood pressure during diastole (diastolic augmentation) resulting in increased coronary perfusion pressure and coronary blood flow. Compression of the extremities also results in an increase in venous return to the heart. Just before the heart ejects blood (systole), air is released rapidly from all the cuffs simultaneously to release the externally applied pressure, allowing the compressed vessels to recover to their normal shape, thereby reducing vascular impedance. As a result, arterial pressure during systole is reduced (systolic unloading), as is cardiac workload. The patient's calves, lower thighs and buttocks are wrapped with cuffs containing air bladders. The patient's ECG is monitored via conventional, high-quality electrodes and detection of the R-wave is used to signal the System when to command sequential inflation of the cuffs. The start and duration of inflation, as well as the start of deflation, are adjustable by the Operator, within limits determined by the System. An algorithm is used to prevent the start of inflation during ejection of blood from the heart and to end inflation and begin deflation prior to the occurrence of the next heartbeat. The pressure applied by the cuffs is also adjustable by the Operator from 150mmHg to 300mmHg (for a patient with a heart rate of 60 bpm). The device also utilizes the following cleared components: ECG/EKG and SpO2: K123711

The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

ECP-MC3 is the most updated designed External Counter Pulsation System for non-invasive treatment of certain cardiovascular and other ischemia related diseases. The ECP-MC3 system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastole begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload. The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors. PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist. The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896

The Renew NCP-5 External Counterpulsation System is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.

The intended use of the ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

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Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat: Poor arterial flow in extremities associated with: - . Ischemic ulcers - Rest pain or claudication (pain with walking) ◆ - t Threatened gangrene - # Insufficient blood supply at an amputation site - Persisting ischemia after embolectomy or bypass surgery - . Pre- and post-arterial reconstruction to improve runoff # Diabetes complicated by the above or other conditions possibly related to arterial insufficiency including: - Nocturnal leg cramps . - Necrobiosis diabeticorum # Venous diseases (once risk of emboli minimized): - . Prophylaxis of deep vein thrombophlebitis - Edema and induration associated with chronic venous stasis . - Venous stasis ulcers . #### Athletic injuries: "Charlie horses", pulled muscles, and edematous muscles

The Circulator Boot Systems are designed to allow pneumatic compression therapy to any extremity (its whole or a part) as prescribed by a physician. A computer within a heart monitor delays compressions after the detection of the QRS complex to allow maximum inflow of blood into the extremities and signals release of the extremity 0.04 seconds before the time of the next QRS complex to maximally reduce afterload and heart work. The part to be treated is first placed into a double-walled plastic disposable bag (legs or arms) or enclosed by a small cuff (such as an elbow). The bagged extremity is then placed within a rigid plastic boot which is adjusted to limit the dead space around the leg. In the case of K792354, adjustment for differences in the length of the extremity is made by applying one of three different length Long Boots ("A". "B" or "C") while adjustments in the width of the extremity is made by moving inner walls snuggly against the part; adjustments for the A-P (anterior-posterior) dimension are accomplished by arcing the thick plastic aprons attached to the inner side of the lateral movable walls tightly down over the extremity. The new "Multicrus" boot K082134 is likewise a rigid plastic boot but telescoping and adjustable in all three dimensions: length, height and width to minimize the space around the bagged leg. It is composed of eight overlapping right-angled plastic pieces which are applied firmly against the extremity. Thus, a piece might be placed under the thigh and knee and against the inner part of the leg (as high up the leg as desired). A second piece may be placed against the lateral aspect of the thigh and knee with its bottom section under the first part. These two parts are pushed together to snuggly hug the inner and lateral parts of the extremity. A third part may then be placed against the inner calf and under the heel and distal part of the first part. A fourth part is placed against the lateral calf and foot and under the heel and the third part and under the second part. The third and fourth parts are again pushed together to snuggly hug the calf and foot. The vertical wall of the fifth part is placed between the vertical walls of the first and third parts while its horizontal wall is placed over the upper leg, again as far up the leg as desired. The vertical wall of the sixth part is placed between the vertical walls of the second and fourth parts and its horizontal part is placed to overlap the thigh and the fifth part. Finally, a seventh and eighth part are placed over the top of the lower leg and foot and over the distal horizontal aspects of the fifth and sixth parts and again are pushed together to minimize the dead space around the lower leg. All are held in place by Velcro patches between the overlapping parts and by straps surrounding the assembled boot. The valve assembly is attached to a plate included on the top of the eighth part and connected then to the compressed air line and the heart monitor. The technician adjusts the pressure knob of the valve assembly as needed to achieve the desired pressure in all of the boot systems. Desired pressures were gained in every patient treated with the Multicrus boot during its five weeks of clinical usage. With all of our boot systems, the physician is encouraged to improvise as necessary to treat patients with special needs (e.g. deformed legs that cannot be straightened out sufficiently to enter our rigid boots). A small cuff is one such improvisation that has allowed treatment of portions of any extremity in concert with treatment of the legs in the Long Boots. This small "Cuff Boot"consists of a juvenile blood pressure cuff to surround the extremity (perhaps a tennis elbow) with a bladder from an adult blood pressure cuff connected to both it and a air-bulb. The bladder is placed over the thigh and beneath the plastic airbag of the Long Boot and, hence, is compressed simultaneously with the leg. The small cuff applies pressure in end-diastole with the same pressure introduced into the Long Boot.

The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.

The intended use of the ECP Health System Model 2005 is for the treatment of patients with: (1). Stable or unstable angina pectoris. (2). Acute myocardial infarction (3). Cardiogenic shock (4). Congestive heart failure

ECP Health System Model 2005 is a positive and negative pressure integrated, non-invasive medical device for performing external sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three parts of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs /buttocks to achieve the desired therapy.

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.