This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Impella 2.5 System
Applicant: ABIOMED, Inc.
Address: 22 Cherry Hill Drive, Danvers, MA 01923 USA
Approval Date: March 23, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/p140003a.pdf
What is it? The Impella 2.5 System includes a mini heart pump mounted at the end of a thin, flexible tube (catheter), a console that drives the pump, and an infusion pump that flushes the pump. The heart pump can be implanted in the left side of the heart without open chest surgery to help pump blood in patients who need short-term support.
How does it work? The Impella System helps the heart pump blood by drawing blood out of the heart and pumping it into the aorta, the main blood vessel leading away from the heart that supplies oxygen-rich blood to the body. A heart doctor (cardiologist) loads the Impella 2.5 heart pump into the tip of the catheter. The catheter tip is inserted through a small incision in a major artery in the leg. The cardiologist guides the catheter tip through the patient’s arteries and the heart pump is positioned into the left side of the patient’s heart (left ventricle). Once in place, an external controller and monitor turns the pump on and off, measures heart function, and allows the cardiologist to adjust the pump as necessary to maintain stable heart function and circulation during the procedure.
When is it used? The Impella 2.5 System is intended to be used during high risk percutaneous coronary intervention (PCI) or stenting procedures (that is, angioplasty and/or placing of a stent in the coronary arteries) performed in high risk, elective or urgent, hemodynamically stable patients with severe coronary artery disease. To be eligible for this procedure, patients must be evaluated by a team of heart doctors, which includes a heart surgeon, that decide coronary artery bypass surgery is not an appropriate option.
What will it accomplish? The use of the Impella 2.5 System in these patients may prevent hemodynamic instability (such as a drop in blood pressure) due to temporary decreases in heart function that may occur during the stenting procedure, allowing more opportunity for a complete opening of the blocked arteries and may reduce adverse events, such as:
- Recurrent episodes of chest pain
- The need for additional stenting procedures
When should it not be used? The Impella 2.5 System should not be used if any of the conditions below apply:
- Defects in the patient’s veins and arteries, including calcium deposits or hardening of the blood vessel walls, which could block the open area available for the pump to pass.
- If the patient has 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;
- Loosely attached clot(s) inside the blood vessels or heart, which may break off while the pump is in use and result in harm.
- 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.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
