Introducing

C-PULSE

C-Pulse® has the potential to revolutionize the treatment of Class III and ambulatory Class IV heart failure. It uses counterpulsation technology to increase cardiac output, coronary artery blood flow and reduce the heart’s pumping workload.

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C-Pulse

The C-Pulse Heart assist system is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure. These symptoms normally include shortness of breath, dizziness, low blood pressure and fluid retention. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life. The C-Pulse Heart Assist System may be implanted through a minimally invasive or full sternotomy technique. 

The C-Pulse System’s design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, the workload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient’s ECG, similar to a pacemaker. Potential benefits of the technology, which are currently being analyzed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac function.

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

1

More oxygen to the heart muscle, called increased coronary blood flow

2

Less work for the heart, called decreased afterload

3

More blood flow from the heart called increased cardiac output


Heart pumps as the cuff deflatesHeart fills with blood then cuff inflates

The C-Pulse System may be implanted via a small pacemaker like incision through the ribs (mini-thoracotomy) and sternum (mini-sternotomy) or through a traditional full sternotomy. The anticipated stay in the hospital may be between 4-14 days.  Several patients currently enrolled in the Company’s FDA approved IDE feasibility trial have been able to return home in as little as four days when the procedure has been performed minimally invasively. 

The implant part of the procedure is typically performed in an hour. The cuff portion of the C-Pulse Device is placed around the ascending aorta, and outside the patient’s bloodstream.  Because of this, the risk of stroke and blood clots is potentially reduced.  There is also no need for patients to take anti-clotting medications such as heparin or warfarin while implanted unless other medical conditions require this.  Because of these features, the procedural and device patient risks may be lower when  compared to other currently approved Class III/IV  mechanical circulatory assist technologies.

The C-Pulse can be temporarily disconnected.  Patients have expressed satisfaction in being able to shower, take a walk and perform other activities independent from the system. 

Download and view the Patient Brochure:


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