Acute Myocardial Infarction (AMI) An obstruction in the blood supply to the heart muscle (usually as a result of clot formation in a coronary artery) which leads to damage to the heart muscle. The lay term is “heart attack”.
Anticoagulation Drug therapy with a class of drug which prevents blood coagulation and thrombus (clot) formation. The most commonly prescribed anticoagulation drug is Warfarin (Coumadin).
Antiplatelet A drug that acts against platelets, the cells that assist blood clotting.
Aorta The main artery from the heart to the rest of the body.
Axial Flow Pump A heart pump where the blood enters and exits in line with the axis of a rotating impeller (like a jet turbine).
Blood damage Destruction of the living cellular component of blood.
Bridge To Transplant (BTT) An LVAD is implanted to support a patient until a donor heart for transplantation becomes available.
Cannulae A tube for insertion into a duct or a cavity. In the case of the VentrAssist™ the tubing that connects the device to the heart and blood vessels.
CE Mark Conformité Européen. A mark applied to a product that is approved for sale in the European Union.
Centrifugal Flow Pump A heart pump where the blood enters in line with the axis of the impeller, but leaves at right angles to the axis of the impeller.
Cerebro-Vascular Accident (CVA) Also known as Stroke, CVA is often caused as a result of clots migrating to the blood vessels in the head, obstructing blood flow to the brain.
Clinical Trials A research study using human subjects which evaluates the safety and efficacy of a medical treatment, drug or device.
Congestive Heart Failure (CHF) A type of heart failure characterised by weakened heart muscle such that the heart can not empty properly and becomes congested with blood.
Destination Therapy (DT) An LVAD is implanted without any intention of replacing it with a transplanted heart.
Device Master Record (DMR) The body of information including the design, development, and manufacturing used for a device.
Dilative Cardiomyopathy (DCM) A chronic heart disease with slow degeneration which usually leads to sudden heart failure due to ventricular arrhythmia or severe heart failure after a long sub-clinical phase.
Dyspnea Shortness of breath.
Electrocardiogram (ECG) The recording of the electrical activity of the heart.
Haemolysis Destruction of red blood cells.
Heart Failure A situation characterised by loss of pumping function of the heart, often due to the consequences of myocardial infarction (“heart attack”).
Hemolysis The rupture of red blood cells. This is an undesirable outcome which can be caused by LVADs. The VentrAssist LVAS causes very low levels of hemolysis by comparison to older types of LVADs.
Hermetic Completely sealed.
Hydrodynamic Operated by the force of liquid in motion.
Impeller A rotating device used to force a fluid in a desired direction under pressure.
Incidence A statistical measure of the number of people who will be diagnosed with a specified disease or condition during a set time (e.g. annual).
Institutional Review Board (IRB) A group of people convened to review proposals for conducting clinical trials on humans. Sometimes called an Ethics Committee.
International Normalized Ratio (INR) A numerical figure used to estimate the clotting time of blood. A patient using Warfarin (e.g. for atrial fibrillation) would normally have a target INR of 2-3.
Investigational device exemption (IDE) A license that the US FDA grants device manufacturers to sell unapproved product in the USA for the purpose of clinical trialing.
Left Ventricular Assist Device (LVAD) A blood pump to aid the function of the left ventricle of the heart.
Medical Device Directive (MDD) A piece of EU legislation covering medical devices.
New York Heart Association (NYHA) The NYHA classifies heart failure, according to functional capacity of the patient, into four classes. Class IV is the most severe, the patients are unable to perform even basic activities of daily living.
Pacemaker A small battery operated device used to send electrical impulses to the heart to control the beating rate.
Percutaneous lead A lead which passes through the skin. In the case of the VentrAssist™ LVAD, the percutaneous lead connects the implanted pump to the external controller.
PM Panel Meeting Part of the PMA process during which the sponsor (i.e. Ventracor) presents data in a public forum to a panel of experts convened by the FDA.
Pre-market approval The process by which information is submitted to the FDA for review prior to the FDA granting permission to market.
Preperitoneal A layer in front of the organs of the lower abdomen but behind the muscles of the lower abdominal wall.
Prevalence A statistical measure of the number of people who have a specified disease or condition at any one time.
Stasis Stoppage of the normal flow of a bodily substance.
Third generation blood pump A blood pump which operates without mechanical contact bearings. This is opposed to a first generation pump, which operates with a pulsatile action, and a second generation device which employs contact bearings.
Thoracic cavity The space within the thoracic walls bounded below by the diaphragm and above by the neck.
Thrombolysis, thrombolytic Thrombolysis is the process by which a thrombus (clot) is broken down by the body’s own systems. A drug which mimics this is caused a thrombolytic.
Transcutaneous Energy Transfer System (TETS) The wireless transfer of electromagnetic energy from an external power source through a medium.
United Network for Organ Sharing (UNOS) A US body that develops and implements guidelines for eligibility and priority of organ transplantation.
Ventricular Fibrillation (VF) An abnormal heart rhythm characterised by chaotic movement of the ventricles which has little or no pump function. Untreated VF leads to death within minutes.
