Step-by-step guide to left heart unloading with the Impella 5.0 heart pump. A distal side port was attached to the arterial cannula so oxygenated blood could be supplied to the right lower extremity itself. Hemodynamic parameters improved immediately after device placement leading to an increase in mean cardiac index from 1.4 to 2.5 L/min/m2 and MAP from 71 mmHg to 83 mmHg. A seemingly ingenuous intravenous blood-flow assistance machine, Impella acts as sort of a miniature airplane propeller built into a catheter inserted through the femoral artery, one … Purge Cassette (0043-0001) A ventricular assist device (VAD) — also known as a mechanical circulatory support device — is an implantable mechanical pump that helps pump blood from the lower chambers of your heart (the ventricles) to the rest of your body. • White Connector Cable Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients (i.e. Historically, intra-aortic balloon pump (IABP) has been the most frequently used support device and has been shown to improve systemic blood pressure and increase coronary blood flow in nonstenotic arteries.1,2 Several studies, however, have demonstrated tha… It's placed inside a person's chest, where it helps the heart pump oxygen-rich blood throughout the body. • 23Fr x 6 cm peel-away introducer with hemostatic valve Mechanical circulatory support (MCS) devices are frequently used to maintain systemic perfusion in cardiogenic shock, acute myocardial infarction, and high-risk percutaneous coronary intervention (HRPCI). patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. Abiomed collaborates with hospitals on Heart Recovery Reunions, which reunite Impella patients with the medical teams who treated them. Delivers forward flow from the left ventricle to the aorta. The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor. Impella technology helps maintain hemodynamic stability and provides left ventricular unloading during a Protected PCI procedure, enabling PCI for patients with severe heart disease. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0®, Impella 5.5® with SmartAssist® and Impella LD® Catheters, in conjunction with the Automated Impella Controller™ (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, Impella 5.5 with SmartAssist and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). Hemodynamics improved in conjunction with a decreased need for inotropic medications. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. • 0.035” x 150 cm guidewire, Part number: 0052-0011 Protected stenting with Impella provides an option for patients who are at high-risk for surgical complications and those with severe heart disease. The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor. Impella 2.5 is a miniaturised, catheter-based, intravascular blood pump that supports a patient's circulatory system. The Impella heart pump is temporary heart support designed to help patients maintain blood flow to the heart, brain, and kidneys during a stenting procedure. Impella Connect enables clinicians to view the Impella control screen through a secure, HIPAA compliant website to track and review cases at any time from any internet-connected device. • 23Fr diameter x 6 cm length peel-away introducer • Impella 5.0 Catheter 4–6 A dextrose-based purge solution flows countercurrent to the blood flow through the device to create a pressure barrier that prevents blood … This active ‘unloading’ of the left ventricle increases blood flow … During Impella support the native left ventricle competes with Impella for volume, likely resulting n left ventricular unloading (True or False) microaxial blood pump, femoral artery The Impella CP is a ___________-that is inserted into the left ventricle through … The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. 2 The Impella … 18 An axial pump is composed of impeller blades, or rotors, that spin around a central shaft and move … This action provides hemodynamic support to the patient by increasing … The balloon keeps blood flowing by inflating and deflating in concert with a person's heartbeat. Echocardiography has an increasing role in ensuring successful implantation of left ventricular assist devices (LVADs) nowadays more extensively employed in patients unresponsive to conventional haemodynamics support. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. • Mounts to controller cart (not shown) for transport within hospital 5 Package: 0043-0003 It is designed to improve patient … • 60 minutes of battery backup power for mobile transport, Part number: 0052-3025 The Impella devices are minimally invasive, catheter-mounted, microaxial-flow pumps. “It can be … The Impella 2.5 aspirates up to 2.5 L/min of blood from the left ventricle and displaces it into the ascending aorta, rapidly unloading the left ventricle and increasing forward flow.It reduces myocardial oxygen consumption, improves mean arterial pressure, and reduces pulmonary capillary wedge pressure. “Impella has the ability to pump blood by pulling the blood directly from the left ventricle and propelling it with forward flow motion through the coronaries as well as to the … This is the first study to investigate the effect of the Impella® on renal blood flow, and with the Impella® device renal blood flow was higher compared to no support. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0®, Impella 5.5® with SmartAssist® and Impella LD® Catheters, in conjunction with the Automated Impella Controller™ (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, Impella 5.5 with SmartAssist and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). These heart pumps … The technology. Overview. • White Connector Cable Actively unloads up to 5.0 L/min from the left ventricle. GMDN Preferred Term Name GMDN Definition; Intracardiac circulatory assist axial-pump catheter A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood … A VAD is used in people who have weakened hearts or heart failure.Although a VAD can be placed in the left, right or both ventricles of your heart, it is most frequently used in the left v… * This condition is a contraindication for the cardiogenic shock indication only. Impella CP®. Top, Device and components: electric engine proximally placed moves blood from endoventricular suction chamber to ascending aorta (outlet area). RECOVER I was a prospective, single-arm, feasibility trial to investigate the safety and feasibility of Impella 5.0 in patients experiencing cardiogenic shock after cardiac surgery.1 Impella 5.0 was successfully placed in all of the 16 patients. • 0.018” x 260cm Placement Guidewire (0052-3005) The Impella 5.5 with SmartAssist will be introduced in the United States through … The Impella LV Support Systems have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. • 14Fr x 13 cm and a 14Fr x 25 cm peel-away introducers with hemostatic valve 0.018” x 260 cm Placement Guidewire (0052-3005), Part number: 0042-0010-US Poorly oxygenated blood passing through the pulmonary circulation to the LV was then pushed forward by the Impella's 1 L/min flow … Guidewire with a radiopaque, shapable tip used for placement of Impella catheter into left ventricle. However, the mean blood pressure should be adequate and in the 60–75 mmHg range and skin color and/or arterial blood gas analysis should reveal acceptable systemic oxygenation. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade* The Impella CP with SmartAssist heart pump allows for sustained peak flows of up to 4.3 L/min (>85% of a normal cardiac cycle). Part number: 005062 Part number: 0043-0002 The Impella heart pump is inserted through a small incision and advanced through the arteries into the heart. The use of Impella heart pumps during a … • 2 White Silicone Plugs, • Impella LD Catheter The controller provides an interface for monitoring and controlling the function of all Impella catheters. Cath Lab Digest talks with Wissam Gharib, MD, FACC, FSCAI, West Virginia University Heart Institute, West Virginia University Hospitals, Morgantown, West Virginia, about his use of the left ventricular assist Impella device … Call for 24-hour Clinical Support1-800-422-8666, Heart pumps that deliver forward blood flow from the left ventricle, Providing education and training to help health care professionals, Resting the left ventricle has proven to increase heart recovery while keeping other therapeutic options open, Integrated microaxial impeller pulls blood from the ventricle into the aorta, After the closing of the sternum, patients can be ambulated with Impella LD while resting their left ventricle. The Impella 5.0 and Impella LD heart pumps are intravascular, microaxial blood pumps that deliver up to 5.0 L/min of forward flow from the left ventricle to the aorta. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of Impella CP Introducer with the single-access approach for interventional procedures. Impella 5.0 is inserted through the axillary artery or femoral cut down. Impella 5.0 is minimally invasive with placement through a single artery and into the left ventricle. Once the impella … 5 Package: 0043-0003 Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury When patients have left heart failure, their doctors may decide to insert an Impella blood pump into their heart to potentially stop the heart failure. * This condition is a contraindication for the cardiogenic shock indication only. •The socket at the gray end of the cable connects to the Impella catheter plug. Clinicians may see a drastic drop or a “zero” value calculated for SpO2, regardless of the true arterial oxygen saturation. Vascular access kit used for axillary insertion sheath of the Impella catheter. • Axillary Insertion Kit •The white plug at the opposite end of the cable is inserted into the blue catheter plug on the front of the Automated Impella Controller, Impella® ventricular support systems for use during cardiogenic shock and high-risk PCI. • 10.4” color display for easy viewing The Impella (Fig.2) then pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta at a maximum rate of 2.5 L… Impella® Catheter (0048-3092) Images of the heart, assessment and quantification of its function together with evaluation and optimization of LVAD's performance are proven issues in this setting. The Impella®RP will be inserted into your femoral veinthrough a small incision in your leg. • 10.4” color display for easy viewing The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. • Purge Cassette (0043-0001) § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The purge cassette delivers rinsing fluid to the Impella catheter. • Mounts to controller cart (not shown) for transport within hospital Visit www.abiomed.com/impella and to learn more. The controller provides an interface for monitoring and controlling the function of all Impella catheters. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by … Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury Methods: From January 2001 to September 2002 inclusive, 16 patients in cardiogenic shock (maximal inotropic support and with IABP in 11 cases) underwent left ventricle unloading with the Impella … The rotor pumps blood from the left ventricle into the ascending aorta, thereby unloading the left ventricle and reducing myocardial oxygen consumption and demand. Background: We planned a study to assess the safety, feasibility, and efficacy of the Impella micro-axial blood pump in patients with cardiogenic shock. Part Number: 0043-0002 The Impella device works by running a small tube up through blood vessels … The white connector cable connects the Impella catheter to the Automated Impella Controller. The left ventricular assist device, LVAD or VAD, is a kind of mechanical heart pump. Impella ventricular support systems for use during cardiogenic shock and high-risk PCI. The Impella axillary insertion kit facilitates placement of the Impella CP with SmartAssist catheter via the axillary artery. Impella provides hemodynamic stability by increasing coronary flow, end organ perfusion, cardiac output and decrease LVEDP to reverse the downward spiral of cardiogenic shock. Impella LD is inserted via the ascending aorta. Reducing Impella® s… Vascular access kit used for percutaneous insertion of the Impella catheter. • Purge Cassette (0043-0001) Introducer Kit (0052-3025) It provides continuous forward flow to increase overall cardiac output, unload work from the ventricle (decreasing myocardial oxygen demand) and improve coronary flow … Learn more about the SmartAssist platform, new features, the Automated Impella Controller™ and specifications. • 8 Fr silicone-coated dilator. • 2 graft locks. Benefits include: Impella LD can be an open-chested, direct support option with 5.0 L/m of flow, when post-cardiotomy cardiogenic shock (PCCS) is unanticipated and fluoroscopy is not available. Visit www.abiomed.com/impella and to learn more, Call for 24-hour Clinical Support1-800-422-8666, Percutaneous insertion, increased flow and intelligent patient management, Providing education and training to help health care professionals. Impella pulls blood from the left ventricle and releases it into the aorta, providing pumping support. Sustained blood flow … Reduces the amount of work your heart has to do Maintains adequate blood flow and blood pressure One problem I had upon admission to the ER, was severe tachycardia. The Impella device works by running a small tube up through blood vessels and into the heart … Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients (i.e. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Impella provides hemodynamic improvements, enables early support, and yields favorable outcomes in the setting of post-cardiotomy cardiogenic shock. While on Impella® support, a patient’s blood flow inherently loses its pulsatile nature, which may cause a patient’s pulsatility to drop or disappear completely. 1–6 We describe the contribution of echocardiography in the use of a new LVAD: th… • Sterile Incision Template, Part number: 0042-0010-US Because the Impella Ventricular Support System acts as a blood pump that effectively bypasses the left ventricle, it supports blood pressure and provides increased blood … • 8,10, 12, 14 Fr dilators An intigrated microaxial pump in the proximal end of the cannula rotates to pull blood from the ventricle into the aorta. In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.
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