3. 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.
4. 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.
5. 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.
6.
7. 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
9. 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
10. 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.
11. Benefits:
Fast recovery, does not
require a surgical
procedure for insertion
Makers to show safety and
probable benefit in a population
of very sick patients
Relief from massive drug therapy
or surgical procedures
13. 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.
14. 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.
15. 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
cured
Overall, 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.
