Sunshine Heart has recently announced it received conditional approval from the Food and Drug Administration (FDA) for its next generation C-Pulse system driver. The new version is designed to enhance patient comfort and performance in those with moderate to severe heart failure.
This new driver, or pump, consists of a single unit that is half the size of its predecessor, is quieter, and has additional software enhancements. Conditional FDA approval will allow the company to use the device for investigational purposes in the US for all sites enrolled in its North American feasibility trial.
It is also expected to be used in the company's future US pivotal trial, once the FDA approves its investigational device exemption (IDE). The C-Pulse heart assist system picked up CE marking in July and is available in Europe. In June, the company also received Health Canada approval to use the C-Pulse system driver in its Canadian study at Royal Victoria Hospital, Montreal.
Heart failure affects nearly 5 million people in the US and has an annual mortality rate of 10 percent. According to Emory Healthcare, approximately 500,000 new cases are diagnosed each year. It is a life-threatening condition, where the heart is unable to pump enough blood to meet the demands of the body. This can lead to buildup of blood and fluid in the lungs, legs and feet.
Common causes of heart failure include coronary heart disease, hypertension and diabetes. Depending on the severity of heart failure, treatment can vary from drug therapy to heart transplants and implantation of cardiac assist devices such as left ventricular assist devices (LVADs), artificial hearts and intra-aortic balloon pumps. Furthermore, the C-Pulse heart assist system uses the principles of intra-aortic balloon counter-pulsation technology to assist and regulate cardiac activity.
The technology aims to reduce the workload of the left ventricle, which delivers oxygen-rich blood to the tissues of the body. The C-Pulse system consists of a cuff that can be inflated or deflated, a driver (pump) and a rechargeable battery. When the cuff is inflated, blood flow to the coronary arteries is increased, supplying the failing heart with additional oxygen.
When the cuff is deflated, the system reduces the workload required to pump blood from the left ventricle. Cuff inflation and deflation in the heart assist system is synchronized to the patient's electrocardiogram (ECG). This system operates outside of the patient's bloodstream (extra-aortic approach), and offers more flexibility to the patient, who can disconnect the device for a period of time.
Researchers expect this device, currently under clinical trials, to relieve patients of symptoms associated with heart failure, such as shortness of breath, reduced cardiac function and physical inactivity.
The cardiac assist devices market in the US, a USD530 million industry, is forecast to grow at a Compound Annual Growth Rate (CAGR) of 11 percent from 2011 to 2018. Traditional therapies such as heart transplantation can have many complications, including organ rejection by the patient, the invasive nature of the procedure, longer hospital stays, the need for intensive drug therapy and longer rehabilitation times.
These are the unmet needs of heart failure treatments that companies like Sunshine Heart are looking to address. Key players in the industry include Heartware International and Thoratec Corporation. Heartware International focuses on developing miniature implantable LVADs for advanced heart failure and received FDA conditional approval in June 2010 for an IDE for its ventricular assist system.
Thoratec Corporation, a veteran of the industry, provides a wide range of ventricular assist devices for mechanical circulatory support in patients with acute and chronic heart failure. Given the competitive landscape, Sunshine Heart's investigational product intends to address the unmet needs of existing therapies such as LVADs, define a target population and improve the quality of life for the patient.
The C-Pulse heart assist system has the potential to prevent the need for later stage heart failure treatments such as LVADs and heart transplants. The C-Pulse system uses minimally invasive procedures to implant the device around the aorta and outside of the patient's blood stream, reducing the risk of stroke and blood clots.
This technology will improve the quality of care and prognosis of these patients. Sunshine Heart needs to bring this product into clinical use and stay ahead of its competitors as they are slowly expanding their markets to target this population.