The C-Pulse System

Every Pulse. Every Day.

C-Pulse device componentsThe C-Pulse Heart Assist System leverages the known concept of counterpulsation. The C-Pulse system applies this concept in an innovative way. Through the application of a balloon wrapped around the outside of the aorta, the C-Pulse System inflates and deflates the balloon in rhythm with the natural heartbeat, applying a “secondary pulse” with the intent to augment (strengthen) the heart’s function.

The C-Pulse is designed to improve the heart function in three ways:

  • Increase coronary blood flow with more oxygenated blood flowing to the blood vessels and heart muscle
  • Decrease cardiac afterload reducing how hard the heart has to work to pump blood through the body
  • Increase cardiac function with more blood being pumped from the heart to the rest of the body

The C-Pulse system is also designed to reduce clinical symptoms associated with moderate to severe (Class III/ambulatory Class IV) heart failure. These symptoms include shortness of breath, dizziness, fluid retention, and limited ability to perform and/or engage in normal day-to-day activities.

The C-Pulse System is being evaluated through clinical studies in the United States and Europe. Early clinical evidence has shown improvement in heart failure patients quality of life and cardiac function. Learn More


C-Pulse System Components

The C-Pulse System includes a non-blood contacting cuff (polymer wrap) with polyurethane balloon, ECG sensing leads, Percutaneous Interface Lead (drive line), and an external driver (pump).

C-Pulse DiastoleThe C-Pulse cuff pumps in rhythm with the natural heartbeat, which is monitored using the ECG sensing leads placed near the left ventricle. The C-Pulse cuff (with balloon) is timed to inflate in between heartbeats, once the heart has finished pumping blood. This allows the balloon inflation to act like a “second pulse,” producing a surge of blood flow to the heart muscle.  The C-Pulse balloon deflates just before the heart pumps blood, reducing the workload of the heart.

The C-Pulse Heart Assist System’s unique design and therapy are intended to:

  • Improve cardiac function
  • Improve patient’s quality of life
  • Reduce re-hospitalizations due to heart failure symptoms
  • Allow patients flexibility to disconnect for short periods (< 15 minutes) of time if needed (e.g. personal hygiene)

How is C-Pulse Different?

Smiling Mature WomanUnlike other technologies that replace the heart’s function and require constant use, the C-Pulse system is designed to assist the current heart’s function by increasing coronary blood flow while decreasing cardiac afterload. The C-Pulse can be implanted using minimally invasive surgical techniques and is typically performed in 90 minutes with no need for cardiopulmonary bypass (stopping the heart)².

For patients the C-Pulse is not life sustaining, meaning they can disconnect from the system for short periods of time. Patients are able to shower or perform other activities independent from the system. The C-Pulse therapy is designed to reduce overall heart failure symptoms, improve quality of life, and reduce re-hospitalization rates due to heart failure.

Early clinical evidence has shown heart failure patients improve in their quality of life and cardiac function. Important Safety Information can be found at the following webpage: Safety Information

 

References
¹JACC Heart Failure Vol. 2, No. 5, 2014
²AHA 2014 abstract Hotz, et. al.