Impella Ventricular Support Systems - P140003/S018
Product Name: Impella Ventricular Support Systems
PMA Applicant: Abiomed, Inc.
Address: 22 Cherry Hill Drive, Danvers, MA 01923
Approval Date: February 7, 2018
Approval Letter: Approval letter
What is it? The Impella Ventricular Support Systems are left-side heart pump systems intended to help pump blood in patients who need short-term support (up to 6 days). The system includes a mini heart pump (Impella 2.5, Impella CP, or Impella 5.0/LD) mounted at the end of a thin, flexible tube (catheter), a console that drives the pump, and an infusion system that flushes the pump.
How does it work? The Impella Ventricular Support System helps pump blood by drawing blood out of the heart and pumping it into the aorta, partially or fully bypassing the left ventricle. It is implanted into the left side of a patient's heart through a small incision in the femoral artery (major artery in the leg). It can also be implanted through a small incision in a subclavian artery (an artery in the chest).
When is it used? Cardiogenic shock is a condition in which the left ventricle of the heart fails to pump enough blood to the body, resulting in inadequate circulation, progressive severe damage to other organs, and even death. When patients with cardiogenic shock are not responsive to conventional treatment measures, additional short term mechanical support of the circulation may be required. The Impella Ventricular Support System may be used temporarily (four days or less for the Impella 2.5 and Impella CP, and6 days or less for Impella 5.0 and LD) to treat cardiogenic shock. Impella device therapy is intended to provide adequate circulation of blood (replace or supplement left ventricle pumping) while also allowing the damaged heart muscle the opportunity to rest and recover. Depending on the severity of the underlying damage to the heart, the device may either be weaned (slowly turned down and removed), or may provide a bridge to additional, more permanent forms of circulatory support. The device has been approved for use in the treatment of sudden episodes of cardiogenic shock that may occur immediately (within 48 hours) after a heart attack or open heart surgery, or in the setting of acute left heart failure in an already diseased heart (cardiomyopathy), during pregnancy, post-partum (following childbirth) (post-partum), or as the result of myocarditis (a viral heart infection).
What will it accomplish? 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 flow to critical organs in patients with cardiogenic shock. This allows the left ventricle to rest and hopefully recover and resume pumping without support. Clinical evidence demonstrated that 58% of patients with cardiogenic shock who received the Impella device survived the procedure, and 67% of patients who left the hospital experienced myocardial recovery (they did not have another heart failure event) within 30 days of the procedure.
When should it not be used? The Impella Ventricular Support System should not be used if the patient has any of the conditions noted below:
- Clot(s) in the left side of the heart, which may break off while the pump is in use and result in harm;
- A replacement heart valve or other heart device, which could block the open area available for the pump to pass;
- Severe narrowing of one of the heart valves, which could block the open area available for the pump to pass;
- A problem with the aortic valve that allows blood to leak back into the left ventricle from the aortic artery—this can cause the heart to work harder and over time may decrease the ability of the heart to supply enough fresh blood to the rest of the body;
- Defects in the patient's veins and arteries, including calcium deposits or hardening of the vessel walls, which could block the open area available for the pump to pass;
- A severe problem with the right side of the heart, which caused it to fail to efficiently pump blood;
- A severe problem with the lungs which prevents the lungs from providing oxygen to circulating blood;
- A defect, such as a small channel in the heart, which could shunt the blood flow between its chambers and reduce pump output;
- A split or rupture of the left side of the heart which results in the leakage of blood out of the left side of the heart;
- A build-up of blood into the space surrounding the heart which blocks its ability to fill with blood.
Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data (SSED) and labeling are available online.