Niki Arrowsmith10.09.12
In August, the U.S. Food and Drug Administration (FDA) granted conditional approval to British company Sunshine Heart Inc.’s next generation C-Pulse heart assist system. The device is designed to enhance patient comfort and performance in patients with moderate to severe heart failure. The new C-Pulse driver, or pump, consists of a single unit that is half the size of its predecessor, is quieter, and has additional software enhancements, according to the company.
Conditional FDA approval allows the company to use the device for investigational purposes in the United States for all sites enrolled in its North American feasibility trial. The company now has received its investigational device exemption (IDE) from the FDA, which allows the product to be used in a soon-to-begin U.S. pivotal trial.
The C-Pulse system received CE marking in July and currently 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 in Montreal.
“We are thrilled to receive conditional approval from the FDA to move forward into a pivotal trial for C-Pulse,” said Dave Rosa, CEO of Sunshine Heart. “[The announcement] represents another significant milestone for the company, as well as for the C-Pulse system. I am especially pleased that we were able to receive this approval on our initial submission. The company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year. These approvals continue to support the company’s market guidance and timelines.”
The company estimates that enrollment for the event-driven trial will take approximately 2.5 years. The primary endpoint of the trial will be fewer heart failure events requiring hospitalization, advanced heart failure therapies and lower heart failure-related mortality rates. A one-year safety follow-up is expected. The lead investigator for the trial will be William T. Abraham, M.D., director of the division of cardiovascular medicine at Ohio State University Medical Center in Columbus. Abraham led a C-Pulse preliminary feasibility study last year, and Sunshine Heart announced positive 12-month extended follow up data from that study in July.
“With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalization rates beginning in 2013 under the Obama health reform act [the Patient Protection and Affordable Health Care Act], the C-Pulse pivotal trial will determine if it will be beneficial to both patients and hospitals alike to improve health outcomes,” said Abraham.
Global Data, a business intelligence analytics company, provides insight into the C-Pulse device. Heart failure affects nearly 5 million people in the United States and has an annual mortality rate of 10 percent. According to Emory Healthcare, a hospital system in Atlanta, Ga., 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 body’s demands, leading to a 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.
The C-Pulse heart assist system uses the principles of intra-aortic balloon counter-pulsation technology to help 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 is intended to offer more flexibility to the patient, who can disconnect the device for a period of time. Researchers expect this device, currently in 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 United States, a $530 million industry, is forecast to grow at a compound annual growth rate 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 attempting to address, say Global Data analysts. Key players in the industry include Heartware International, which develops miniature implantable LVADS for advanced heart failure, and Thoratec Corporation, which provides ventricular assist devices for mechanical circulatory support in patients with acute and chronic heart failure. Given the competitive landscape, Sunshine Heart’s investigational product is designed to address the unmet needs of existing therapies such as LVADs, define a target population and improve the quality of life for the patient.
With the C-Pulse heart assist system, Sunshine Heart hopes to prevent the need for later stage heart failure treatments such as LVADs and heart transplants. With LVADs, patients need to take anti-coagulant medications, which according to the company, is not required for C-Pulse heart assist treatment. Complications with LVADs include bleeding (experienced by 40-50 percent of patients), development of blood clots, damage to coronary arteries, stroke and kidney failure. The C-Pulse system uses minimally invasive procedures to implant the device around the aorta and outside the patient’s blood stream, reducing the risk of stroke and blood clots. With LVADs, the patient has to wear the device continuously, to the point where the heart can become dependent on the device. The C-Pulse heart assist system allows the patient to temporarily disconnect from the device to perform activities independent of the system, such as walking and taking a shower.
Sunshine Heart’s C-Pulse heart assist system with the new driver potentially can address issues associated with current products in the market and change the treatment paradigm, Global Data concludes. The product’s target population consists of patients with moderate (Class III) and severe (ambulatory Class IV) heart failure for whom only a few therapeutic options exist. This technology aims to improve the quality of care and prognosis of these patients.
Image of C-Pulse heart assist system courtesy of Sunshine Heart.
Conditional FDA approval allows the company to use the device for investigational purposes in the United States for all sites enrolled in its North American feasibility trial. The company now has received its investigational device exemption (IDE) from the FDA, which allows the product to be used in a soon-to-begin U.S. pivotal trial.
The C-Pulse system received CE marking in July and currently 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 in Montreal.
“We are thrilled to receive conditional approval from the FDA to move forward into a pivotal trial for C-Pulse,” said Dave Rosa, CEO of Sunshine Heart. “[The announcement] represents another significant milestone for the company, as well as for the C-Pulse system. I am especially pleased that we were able to receive this approval on our initial submission. The company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year. These approvals continue to support the company’s market guidance and timelines.”
The company estimates that enrollment for the event-driven trial will take approximately 2.5 years. The primary endpoint of the trial will be fewer heart failure events requiring hospitalization, advanced heart failure therapies and lower heart failure-related mortality rates. A one-year safety follow-up is expected. The lead investigator for the trial will be William T. Abraham, M.D., director of the division of cardiovascular medicine at Ohio State University Medical Center in Columbus. Abraham led a C-Pulse preliminary feasibility study last year, and Sunshine Heart announced positive 12-month extended follow up data from that study in July.
“With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalization rates beginning in 2013 under the Obama health reform act [the Patient Protection and Affordable Health Care Act], the C-Pulse pivotal trial will determine if it will be beneficial to both patients and hospitals alike to improve health outcomes,” said Abraham.
Global Data, a business intelligence analytics company, provides insight into the C-Pulse device. Heart failure affects nearly 5 million people in the United States and has an annual mortality rate of 10 percent. According to Emory Healthcare, a hospital system in Atlanta, Ga., 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 body’s demands, leading to a 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.
The C-Pulse heart assist system uses the principles of intra-aortic balloon counter-pulsation technology to help 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 is intended to offer more flexibility to the patient, who can disconnect the device for a period of time. Researchers expect this device, currently in 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 United States, a $530 million industry, is forecast to grow at a compound annual growth rate 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 attempting to address, say Global Data analysts. Key players in the industry include Heartware International, which develops miniature implantable LVADS for advanced heart failure, and Thoratec Corporation, which provides ventricular assist devices for mechanical circulatory support in patients with acute and chronic heart failure. Given the competitive landscape, Sunshine Heart’s investigational product is designed to address the unmet needs of existing therapies such as LVADs, define a target population and improve the quality of life for the patient.
With the C-Pulse heart assist system, Sunshine Heart hopes to prevent the need for later stage heart failure treatments such as LVADs and heart transplants. With LVADs, patients need to take anti-coagulant medications, which according to the company, is not required for C-Pulse heart assist treatment. Complications with LVADs include bleeding (experienced by 40-50 percent of patients), development of blood clots, damage to coronary arteries, stroke and kidney failure. The C-Pulse system uses minimally invasive procedures to implant the device around the aorta and outside the patient’s blood stream, reducing the risk of stroke and blood clots. With LVADs, the patient has to wear the device continuously, to the point where the heart can become dependent on the device. The C-Pulse heart assist system allows the patient to temporarily disconnect from the device to perform activities independent of the system, such as walking and taking a shower.
Sunshine Heart’s C-Pulse heart assist system with the new driver potentially can address issues associated with current products in the market and change the treatment paradigm, Global Data concludes. The product’s target population consists of patients with moderate (Class III) and severe (ambulatory Class IV) heart failure for whom only a few therapeutic options exist. This technology aims to improve the quality of care and prognosis of these patients.
Image of C-Pulse heart assist system courtesy of Sunshine Heart.