EECP Products
Enhanced External counter-pulsation (EECP) device is a noninvasive circulation assist device for the treatment of ischemic heart disease. These devices apply external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and release of the external pressure during systole to reduce left ventricular workload. EECP Device Description
EECP system con
sists of three sets of inflatable pressure cuffs wrapped around the calves, the lower and upper thighs, including the buttocks. The cuffs are rapidly and sequentially inflated, starting from the calves and proceeding upward to the buttocks during the relaxation (diastolic) phase of each heartbeat, creating a strong arterial retrograde flow towards the heart and significantly increasing blood flow to the coronary arteries at a time when resistance to coronary blood flow is at its lowest level. The inflation of the cuffs also simultaneously increases the volume of venous blood returned to the right side of the heart, providing greater filling of the ventricle for ejection. Just before the beginning of the next cardiac cycle when the heart begins to contract, all three cuffs simultaneously deflate, leaving an empty vascular space in the lower extremities to receive blood ejecting from the heart, thereby significantly reducing the workload of the heart. The inflation/deflation activity is monitored constantly and coordinated by a microprocessor that interprets electrocardiogram signals, monitors heart rhythm and rate information, and actuates the inflation and deflation in synchronization with each cardiac cycle (see Figure 1). The inflation/deflation cycle is repeated every heartbeat, increasing energy supply to the heart, improving cardiac output, while at the same time reducing the workload of the heart. EECP Treatment Systems
There are six different EECP® Therapy models developed over the past 18 years, as shown in Figure 2. The first model was MC2 designed with five components: Display-Control Console, Power Supply Console, the Treatment Table with Inflation/deflation valves, the Compressor Console and the Patient-Cuffs/Bladders set. Model TS3 and TS4 are the second generation of the EECP® Therapy System with the Display- Control Console, the Compressor Console and the Power Supply Console integrated into a single unit. They were designed with digital regulation of the applied external pressure to control précised pressure application. Pulse Oximetry is used to monitor oxygen saturation of the patients as a safety measure of their oxygen level in their blood. The Control Console also accommodates a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing electrocardiograph (ECG), finger plethysmograph and oxygen saturation signals. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation, as shown in Figure 3. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is monitored with an internal pressure sensor. The operator selected the applied pressure set point and it will be maintained by a closed-loop control system. The touch screen employs “hardware-less keys” which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data. The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve assembly (TS3). The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses. The Model AngioNew V, AngioNew VI and Lumenair are the latest generation of the EECP Therapy Systems with single-component design. All necessary parts are housed inside a single console, namely: the Treatment Table in AngioNew V, and Lumenair, while the Mobile AngioNew VI comes even without the Treatment Table. These new models have all the performance characteristics as MC2, TS3 and TS4, but they are much smaller in footprint, save working space and easier to move around. AngioNew V is truly a mobile system that can be wheeled in hospital from room-to-room to patients’ bedside, especially to the emergency room or catheterization laboratory. Lumenair has a special patented curve-surface that prevents motion of the patients up and down the Treatment Table and provides comfort to the patients as well as the operators who don’t have to bent over to wrap the Cuffs/Bladders set around the extremities of the patients. Software
Software verification and validation, as follows:
• Functional requirements as defined in the EECP® Therapy System with Pulse Oximetry System Requirements Specification.
• Boundary values and stress testing as defined by FDA’s Guidance for the Content of Premarket Submission for Medical Devices Containing Software, CDRH, ODE, FDA, May, 1998.
• Safety requirements as identified in the safety risk analysis performed in accordance with EN 14971-1, Medical Device Risk Analysis, October, 1994, the “Essential Requirements of the Medical Devices Directives”, 14 June, 1993, and IEC 601-1-4, Medical Electrical Equipment Part 1: General requirements for safety, 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
• Testing in support of validation in accordance with the FDA’s General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11, 2002, and IEC 601-1-4, Medical Electrical Equipment Part 1: General requirements for safety, 4 Collateral Standard: Programmable electrical medical systems, 1996-05. Verification of System operation, as follows:
• Functional requirements as defined in the EECP® Therapy System with Pulse Oximetry System Requirements Specification to verify the performance of the modified device at the system level.
• Safety requirements as identified in the safety risk analysis performed in accordance with EN 14971-1, Medical Device Risk Analysis.
• Additional verification tests, as indicated, to verify performance at the component level.
• Biocompatibility testing in conformity with recognized standards ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12.
2. Regulatory
US Food and Drug Administration (FDA) has cleared all Vasomedical EECP systems to market internationally. In addition, all Vasomedical EECP systems have been designed, manufactured, installed and service according to International ISO 13485 standard. They have satisfied US Underwriters Laboratory (UL) Medical Electrical Equipment EN 60601 standards, certified with the European quality assurance CE mark, and passed all tested in accordance with Medical Device Risk Analysis EC 149971. Intended Use
The Vasomedical EECP® Therapy Systems are devices for the treatment of patients suffering from:
• Stable or unstable angina pectoris,
• Congestive heart failure,
• Acute myocardial infarction,
• Cardiogenic shock
Contraindications
The Vasomedical EECP systems should not be used for the treatment of patients with:
• Arrhythmias that interfere with machine triggering,
• Bleeding diathesis,
• Active thrombophlebitis,
• Severe lower extremity vaso-occlusive disease,
• Presence of a documented aortic aneurysm requiring surgical repair,
• Pregnancy. Precautions
• Patients with blood pressure higher than 180/110 mmHg should be controlled prior to treatment with enhanced external counterpulsation.
• Patients with a heart rate more than 120 bpm should be controlled prior to treatment with enhanced external counterpulsation.
• Patients at high risk of complications from increased venous return should be carefully chosen and monitored during treatment with enhanced external counterpulsation. Decreasing cardiac afterload by optimizing diastolic augmentation may help minimize increased cardiac filling pressures due to venous return.
• Patients with clinically significant valvular disease should be carefully chosen and monitored during treatment with enhanced external counterpulsation. Certain valve conditions, such as significant aortic insufficiency, or severe mitral or aortic stenosis, may prevent the patient from obtaining benefit from diastolic augmentation and reduced cardiac afterload in the presence of increased venous return. EECP patient selection and contraindications as well as precautions should be followed carefully to avoid risk of adverse clinical events. Blood pressure, respiration rate, oxygen saturation and weight should be monitored during EECP treatment to avoid exacerbation of heart failure, especially in patients with low ejection fraction. Physical assessment, especially peripheral skin condition, should be examined after every treatment session. Patients are advised to wear a stretchable treatment pants comprised of cotton and Lycra (Spandex) under the Cuffs/Bladders Set to avoid injury by constant rubbing of the skin, and to allow greater patient comfort during treatment. The treatment is administered to patients on an outpatient basis, usually in daily one-hour sessions, five days per week over seven weeks for a total of 35 treatments. EECP is equally effective if it is given twi
