CytoSorbents Corporation (CTSO)

[Canes16]

Interesting. Very small test. Hope we are having the same discussion with the FDA.



Impella RP® System - P170011

Impella RP® System

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 (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 RP® System
PMA Applicant: ABIOMED, Inc.
Address: 22 Cherry Hill Drive, Danvers, MA 01923
Approval Date: September 20, 2017
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf17/P170011a.pdf

What is it? The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. It includes a mini heart pump 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 RP heart pump helps pump blood from a blood vessel outside the heart (inferior vena cava), bypassing the right heart (right atrium and right ventricle), into a blood vessel leading to the lungs (pulmonary artery). It is implanted into the right side of a patient's heart through a small incision in the major vein in the leg (femoral vein).

When is it used? The Impella RP may help patients who require emergency temporary support of right ventricular function. 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 fails after a heart transplant.
•Patients whose right 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 right ventricle must do. While the Impella RP is working, the patient's right heart has time to rest and recover its ability to pump blood. Once the right side of the patient's heart is working on its own again, the Impella RP can be removed. If the patient's 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 clinical studies totaling 60 patients, about 3 out of 4 patients survived for at least 30 days after the device was removed. The main complications observed in the clinical studies were bleeding during the pump placement procedure (48 out of 100 patients) and damage to red blood cells (hemolysis; 27 out of 100 patients).

When should it not be used? The Impella RP should not be used if the patient has the following conditions:
•Defects in their 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 rigid replacement heart valve, or a leaky or severely narrowed tricuspid or pulmonary valve;
•Loosely attached clot(s) in their blood vessels or heart, which may break off while the pump is in use and result in harm to the patient;
•Anatomic conditions that do not allow the blood pump to be inserted; and/or
•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 (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170011