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 Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Impella RP System
HDE Applicant: ABIOMED, Inc.
Address: 22 Cherry Hill Drive, Danvers, MA 01923
Approval Date: January 23, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/H140001a.pdf
What is it? The Impella RP 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 right 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 RP is implanted into the right side of a patient's heart through a small incision in the major vein in the leg (femoral vein). It helps pump blood from outside the heart, from a blood vessel called the inferior vena cava, through the heart into a blood vessel leading to the lungs, called the pulmonary artery.
When is it used? The Impella RP may help pediatric and adult patients who require emergency support of the right heart. Typical patients who may use the device include:
- Patients whose right heart fails after receiving a heart pump to support the left side of the heart.
- Patients whose right heart fails because of a heart attack.
- Patients whose right heart fails after a heart transplant.
- Patients whose right heart fails after heart surgery.
The Impella RP is implanted in a hospital. Patients who receive the device must stay in the hospital until it is removed, which may be up to 14 days.
What will it accomplish? The Impella RP helps reduce the amount of work a patient's own heart must do. While the Impella RP is working, the patient's heart has time to rest and recover its ability to pump blood. Once the patient's right heart is working on its own again, the Impella RP can be removed. If the patient's right heart does not recover within two weeks, the patient may need a different treatment such as a permanent heart pump or a heart transplant. In the U.S. clinical trial, about 3 out of 4 patients who received the device survived to at least 30 days after the device was removed.
When should it not be used? The following physical conditions may interfere with the placement or performance of the device:
- 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.
- A replacement heart valve, which could block the open area available for the pump to pass.
- A faulty heart valve which could cause blood flowing in the wrong direction and reduce the pump's output.
- Severe narrowing of one of the patient's heart valves which could block the open area available for the pump to pass.
- A defect, such as a small channel in the patient's heart, which could connect the blood flow between its chambers and reduce the pump's output.
- Loosely attached clot(s) in the patient's blood vessels or heart, which may break off while the pump is in use and result in harm to the patient.
- A blood filter in one of the patient's large veins which may block the open area available for the pump to pass.
Additional information: The Summary of Safety and Probable Benefit and labeling are available online.