Pooja Shah

Approved: January 23, 2015(Right-Sided Percutaneous Support)

Patient: Erin • Erin loves to run and do physical activities.

• One day she went out to the park with her sister and fell down while running. At first people thought she's having a heart attack, well she was.

• At a young age of 24 she needs a heart transplant since her right side of the heart is no longer able to pump enough to supply blood with oxygen and nutrients to the organs of the body. 

What is Impella RP? (Right-Sided Percutaneous Support)

The pump is designed to give the minority of heart patients lacking blood flow from the right side of their hearts the pressure needed to compensate for right heart failure. Impella RP gained Humanitarian Device Exemption (HDE) approval in January 2015

This innovative medical device is the first percutaneous single access heart pump designed for right heart support.

How does it work?

During use, the Impella RP Catheter is percutaneously placed across the tricuspid and pulmonic valves via a single femoral venous access through a small hole in the leg. It actively unloads the right ventricle by pumping blood from the inferior vena cava (IVC) into the pulmonary artery (PA)

The AIC generates the signals required to power the drive motor of the catheter and provides the user interface.

The AIC also incorporates the disposable Impella Purge Cassette purge system, which provides a pressure barrier to prevent blood from entering the catheter’s drive motor.

Who may use Impella RP??

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

F.A.B

Features: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 pump can provide up to four liters per minute for as long as two weeks in patients with acute right heart failure

Delivered through a catheter requiring only a small hole in the leg, circulatory assistance for up to 14 days in pediatric or adult patients

Advantages:

Helps pediatric and adult patients who require emergency support of the right heart.

Indicates to help 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.

Benefits:

Fast recovery, does not require a surgical procedure for insertionMakers to show safety and probable benefit in a population of very sick patients

Relief from massive drug therapy or surgical procedures

Training:

rigorous training will incorporate members of the heart team including:•the interventional cardiologist •cardiac surgeon•heart failure cardiologist•lead nurse

Pricing:

The list price for the new Impella RP is expected to be between $20,000 and $25,000

Impella revenues grew almost 37% year over year on a global basis

While an additional 21 hospitals purchased Impella heart pumps during the quarter, reaching the installed customer base to 931 sites at the end of the quarter. 

Contraindications:

Defects in the patient's veins and arteries •calcium deposits or hardening of the blood vessel walls

• which could block the open area available for the pump to pass.

Defect of a small channel in the patient's heart •could connect the blood flow between its chambers

• reduces the pump's output.  Clots in the patient's blood vessels or heart •may break off while the pump is in use

• result in harm to the patient.

A blood filter in a large veins •may block the open area available for the pump to pass.

Why you need Impella RP??One of the best inventions that is  minimally invasively and quickly able to insert a tube inside the heart

FDA initially approved the Impella RP for a subset of only about 4,000 patients based on the results of a clinical study that enrolled 30 patients, now about 25 hospitals own this device and over thousands patients have been curedOverall, the survival rate was 73 percent in the entire population at 30 days. Cohort A showed a survival rate of 83.3 percent and Cohort B showed a 58.3 percent survival rate at 30 days.

•Cohort A -  patients who developed RVF within 48 hours after implantation of a left ventricular assist device. •Cohort B - patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction shock.