MINIMALLY INVASIVE HEMODYNAMIC SUPPORTStabilize. Unload. Recover.

Impella 5.0® Heart Pump

Safe and effective in patients presenting with post-cardiotomy and AMI cardiogenic shock1 Full hemodynamic support promotes myocardial recovery by stabilizing hemodynamics, unloading the left ventricle, and perfusing the coronaries and end organsActively unloads the LV and increases coronary perfusion, thereby improving the myocardium oxygen supply/demand ratio2,3

Impella 5.0 provides circulatory support to enable heart recovery

More than 65,000 patients have been treated with the Impella platform of heart pumps in the United States.4

Impella 5.0® Heart Pump For Patients with AMI Cardiogenic Shock

An intravascular microaxial blood pump offering full hemodynamic support. Catheter Diameter: 9 Fr

Micro-axial pump 21 FrFlow Rate: 5 L/min

Blood Inlet

Pump Motor

Micro-axial Blood PumpDelivers forward flow from the left

ventricle to the aorta.

Pigtail

Single Access PointMinimally invasive placement through a single artery and into the left ventricle.

Direct Ventricular Unloading Actively unloads up to 5 L/min

from the left ventricle.

Blood Outlet

Without hemodynamic support, patients with post-cardiotomy cardiogenic shock (PCCS) continue to have poor outcomes6

PCCS occurs in patients with normal preoperative myocardial function as well as those with pre-existing impaired function6

Refractory PCCS leads rapidly to multi-organ dysfunction and is often fatal6

of surviving patients recovered their native heart function1

93%

Patients and Methods1

Post-cardiotomy and AMI Cardiogenic Shock patientsBaseline EF 23% (±7%)93% Multi-vessel disease 70% either emergent or urgent

Post-Cardiotomy and AMI Cardiogenic Shock Approximately 0.2% to 6% of patients undergoing coronary or valvular cardiac procedures will develop PCCS.5

Clinical Results1

Hemodynamic indexes improved immediately once support was initiated. Less inotropes required post implantLow adverse events

RECOVER I1: FDA Pivotal Safety Study A prospective, single-arm study, involving 16 enrolled patients. The primary efficacy endpoint was survival of the patient to implementation of the next therapy, which included recovery at 30 days after device removal.

Blood Inlet

In-Hospital Mortality1

34%

12%

Predicted Observed

(N=16)

Survival1

Time of Follow-up

Surv

ival

%

30 Days 3 Months 1 Year

100

80

60

40

20

0

75%81%94%

STS Score1

MINIMALLY INVASIVE HEMODYNAMIC SUPPORTStabilize. Unload. Recover.

The Impella® 5.0 Heart Pump Allows for Patient Ambulation

2 Graft locks 23 Fr x 6 cm Peel-away introducer with hemostatic valve8 Fr Silicone-coated dilator

IMP-

021

ABIOMED, Inc.22 Cherry Hill Drive, Danvers, MA 01923 USAVoice: 978- 646-1400Facsimile: 978- 777-8411Email: marketing@abiomed.com

www.abiomed.com© 2018 ABIOMED, INC. ALL RIGHTS RESERVED.

Clinical Support 24 hours per day, 7 days a week:1- 800- 422- 8666 (US)

INDICATIONS FOR USE

Cardiogenic Shock The Impella 2.5®, Impella CP®, Impella 5.0®, 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 and Impella CP, and ≤ 6 days for the Impella 5.0, 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 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 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.Important Risk Information for Impella devices CONTRAINDICATIONSThe Impella 2.5, Impella CP, Impella 5.0 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 0.6 cm2 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** This condition is a contraindication for the cardiogenic shock indication only. POTENTIAL ADVERSE EVENTSAcute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injuryIn addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit www.abiomed.com/important-safety-information

Learn how the Impella device provides hemodynamic support. Download the Impella® App Avaliable on iTunes® or Google play.

The Axillary insertion kit

References: 1. Griffith, Journal of Thoracic and Cardiovascular Surgery, 2012 2. Garatti A, Colombo T, Russo C, Lanfranconi M, Milazzo F, Catena E, et al. Different applications for left ventricular mechanical support with the Impella Recover 100 microaxial blood pump. J Heart Lung Transplant. 2005;24:481-5. 3. Siegenthaler MP, Brehm K, Strecker T, Hanke T, N€otzold A, Olschewski M, et al. The Impella Recover microaxial left ventricular assist device reduces mortality for postcardiotomy failure: a three-center experience. J Thorac Cardiovasc Surg. 2004;127:812-22. 4. Abiomed Data on File. 5. Sylvin EA, Stern DR, Goldstein DJ. Mechanical support for postcardiot-omy cardiogenic shock: has progress been made? J Card Surg. 2010;25:442-54. 6. Khorsandi et al. Journal of Cardiothoracic Surgery (2016) 11:29.