Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923. 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. In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. • 8 Fr silicone-coated dilator. 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. Vascular access kit used for axillary insertion sheath of the Impella catheter. with SmartAssist®. • Purge Cassette (0043-0001) Impella 5.0® and Impella LD®. The Impella 2.5, Impella CP, Impella CP with SmartAssist ®, Impella 5.0 ®, Impella LD ®, and Impella 5.5™ with Smart Assist ® are U.S. FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella heart pump is an intravascular microaxial blood pump that supports a patient’s circulatory system. The latest innovation on the Impella platform integrates the trusted performance of the Impella CP heart pump with state-of-the-art SmartAssist technology. Part number: 0043-0002 Visit ProtectedPCI.com to learn about training opportunities, watch case reviews featuring real world data and outcomes with the Impella … 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). The Impella CP with SmartAssist is designed to run at a constant motor speed in response to the real-time changes in pressures in the aorta and left ventricle. Die Impella CP mit SmartAssist Herzpumpe wurde von der amerikanischen Gesundheitsbehörde FDA als sicher und wirksam für den Einsatz bei PCI-Prozeduren mit hohem Risiko und für Patienten im kardiogenen Schock eingestuft. • 2 Silicone Plugs, Part number: 0042-0010-US Visit www.abiomed.com/impella and to learn more. Impella 2.5® Impella CP® with SmartAssist® ... Abiomed collaborates with hospitals on Heart Recovery Reunions, which reunite Impella patients with the medical teams who treated them. Next Generation Heart Recovery Technology. Learn more about the features of the Impella 5.5 with SmartAssist heart pump. • Inserted percutaneously through the femoral artery • Inlet directly unloads the left ventricle reducing ventricular work for up to 5 days for indications including support during high-risk PCI and support post AMI CGS Designed for surgeons with forward flow and intelligent patient management. Easier management and repositioning: SmartAssist sensor allows for precise positioning in the aorta and left ventricle and repositioning in the ICU without the need for catheterization lab or ultrasound imaging. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with Smart Assist are the US FDA approved heart pumps for the treatment of heart attack or cardiomyopathy patients in cardiogenic shock. 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. Impella 5.5 with SmartAssist delivers full cardiac support with maximum unloading, allowing the heart to rest and recovery. Impella 5.5 with SmartAssist for use during cardiogenic shock. Cardiogenic shock is a life-threatening situation that occurs when the heart’s inability to function causes organs in the body to begin to fail. 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 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). with SmartAssist®. * This condition is a contraindication for the cardiogenic shock indication only. DANVERS, Mass. Answer a few questions to see if you may be a candidate. Minimally invasive heart pump with intelligent technology to improve patient outcomes with peak flows up to 4.3 L/min, Providing education and training to help health care professionals. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. -- (BUSINESS WIRE)--May 16, 2019-- Abiomed (NASDAQ:ABMD) announces today that the Impella CP with SmartAssist, which is designed to improve patient outcomes with advanced algorithms and simplified patient management, will be commercially available beginning at the 2019 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions through … In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Abiomed announces today that the Impella CP with SmartAssist, which is designed to improve patient outcomes with advanced algorithms and … Watch Video Instructions for Use. A study published in the journal ASAIO examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. 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. At the forefront of innovation, according to a press release, these advances in technology and software are designed to improve productivity, ease of use, and patient management to ensure optimal patient care. 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. with SmartAssist. The controller provides an interface for monitoring and controlling the function of all Impella catheters. By completing this form, you are consenting to receiving emails regarding updates to the program, downloadable templates, case reviews, specialists opinions, and best practices. It is a microaxial, surgically implanted heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow recovery and early assessment of residual myocardial function. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Impella CP. This heart pump is designed for long-duration support, enables patient mobility and … 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* Overview. • Axillary Insertion Kit (0052-3009) • 10.4” color display for easy viewing Impella CP. The Impella 2.5 ®, Impella CP ®, Impella CP ® with SmartAssist, Impella 5.0 ® and Impella LD ® are FDA-approved heart pumps used to treat heart attack or … The pump features an … Part number: 0052-3005 The Impella CP with SmartAssist heart pump is designated as safe and effective by the FDA for use during high-risk PCI procedures and for patients in cardiogenic shock. Device: Impella CP with Smart Assist (Circulatory Support System) Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). 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. Abiomed (NSDQ:ABMD) said today it is launching its Impella CP with SmartAssist, which won FDA approval last March.. The Impella CP® with SmartAssist heart pump is designed to improve outcomes by using real-time intelligence to optimize positioning, managing and weaning of the Impella device for better patient care. Guidewire with a radiopaque, shapable tip used for placement of Impella catheter into left ventricle. • 60 minutes of battery backup power for mobile transport, Part number: 0052-3009 The Impella 5.5 with SmartAssist heart pump delivers full cardiac support, allowing the heart to rest and enabling the heart to achieve its natural pumping function without additional support. Neuenhofer Weg 3 The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. A heart pump designed for surgeons with forward flow and intelligent patient management. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. Learn How to Improve Outcomes with the Impella Platform. This next generation heart pump is designed to improve patient outcomes by using real-time intelligence to optimize positioning, managing and weaning of the Impella … The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved … The Impella 2.5®, Impella CP®, Impella CP®with SmartAssist, Impella 5.0® and Impella LD® are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to … Call for 24-hour Clinical Support1-800-422-8666, A heart pump designed for surgeons with forward flow and intelligent patient management, Providing education and training to help health care professionals. 0107 Impella CP SmartAssist Brochure 2019 V02. It is a microaxial, surgically implanted heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to … 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, … It is a minimally invasive, temporary heart pump that uses real-time intelligence associated with improved survival and heart recovery. Protected PCI, or protected stenting, is a proven and widely accepted procedure using Impella® to temporarily assist the pumping function of the heart. 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* Visit www.abiomed.com/impella and to learn more. * This condition is a contraindication for the cardiogenic shock indication only. Impella CP with SmartAssist is the only mechanical circulatory support device that calculates and displays LVEDP, MAP and CPO. 5 Package: 0043-0003 Smaller access for unloading the left ventricle. During treatment for cardiogenic shock, Impella supports the heart’s pumping function, providing blood and oxygen to vital organs. • 2 graft locks Learn more about the SmartAssist platform, new features, the Automated Impella Controller and specifications. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. Study authors and cardiac surgeons Ed Soltesz, MD, Mark Anderson, MD, and Danny Ramzy, MD, conclude Impella 5.5 with SmartAssist is clinically appropriate for a number of challenging scenarios, including AMI cardiogenic shock.1, Survivors recovered native heart function1, Part number: 0550-0008 The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved … It is a minimally invasive, temporary heart pump that uses real-time intelligence associated with … • Impella® Catheter (0550-0007) The Impella CP with SmartAssist heart pump is designated as safe and effective by the FDA for use during high-risk PCI procedures and for patients in cardiogenic shock. • 23Fr x 6 cm peel-away introducer with hemostatic valve The Impella 2.5 ®, Impella CP ®, Impella CP ® with SmartAssist, Impella 5.0 ® and Impella LD ® are CE-marked and FDA-approved heart pumps used to … The CP Smart Assist, the latest innovation on the Impella platform which integrates the trusted performance of the Impella CP heart pump with state-of-the-art Smart Assist technology. The Impella system varies the amount of current supplied to the motor to maintain a constant motor speed and that variation correlates with the differential pressure (AoP – LVP) across the pump. The launch will begin alongside the … • 0.018” x 260cm Placement Guidewire (0052-3005)