Patients with heart failure who no longer get symptom relief from medications may have a new treatment option on the horizon with the FDA's conditional approval this week of an investigational device exemption (IDE) to Sunshine Heart (Sydney, Australia) to begin its first U.S. clinical trial for the C-Pulse, an implantable aortic cuff heart assist device.
"Almost 1.4 million patients have moderate heart failure," Sunshine's CEO Donald Rohrbaugh told Medical Device Daily. "Thirty percent have an electrical disorder and pacemakers are addressing this problem. But that leaves 70% with a large unmet clinical need. They have a progressive condition and they often end up with end-stage heart failure."
Sunshine's cuff, which functions like a blood pressure cuff, wraps around the aorta and a balloon inflates to displace blood in the aorta. It's being positioned as a Class III heart failure therapy that offers an intervention bridging the clinical gap between heart failure pacemakers and end-stage therapies.
Implantation is performed via a simple surgery on a beating heart, without the need for heart-lung bypass or any incisions to the heart or great vessels.
"We've already trained quite a few surgical centers to implant the C-Pulse," Rohrbaugh said. "One doctor described the procedure as a 'chip shot.' Another said 'this is almost an outpatient procedure.' Because it's outside the blood stream, it's a simple surgery."
Enrollment is expected to begin at six U.S. medical institutions by the end of 2008. The objective of the trial is to evaluate the safety and efficacy of C-Pulse in 20 patients suffering from moderate heart failure.
William Abraham, MD, of Ohio State University (Columbus), and Patrick McCarthy, MD, of Northwestern University Medical Center (Chicago), will serve as national co-lead principal investigators. Each patient's performance with C-Pulse will be monitored over a six month follow-up period.
Assuming the data from the trial is positive, Sunshine will then request CE Mark approval to market C-Pulse in the European Union and other international countries. The company also intends to seek FDA approval for a larger pivotal study to support the submission of a marketing application for C-Pulse in the U.S.
The C-Pulse is said to increases coronary and cardiac flow, unload the heart, reduce wall stress, offers quick patient recovery, relieves symptoms and improves their quality of life.
"We increase blood flow to the heart muscle by over 60% and increase total blood flow to the body by over 30%," Rohrbaugh told MDD. "With that additional blood flow, they can get relief of symptoms and improved quality of life."
When asked how long the C-Pulse can offer this type of relief, Rohrbaugh estimated two to four years, but said the trials will confirm that time period.
"These patients are going to get worse eventually," he said. "Physicians are looking for us to improve the quality of life of these patients. But this technology hasn't precluded the medical community to perform all the other procedures they have in their bag of tricks."
C-Pulse uses a standard pacemaker lead, a single soft percutaneous line and an external pneumatic battery-operated driver. The driver unit is about the size of a CD player and is worn outside of the body along the hip and linked by an air tube to the cuff. The cuff is secured around the ascending aorta.
The company eventually plans to make the C-Pulse a fully implanted device.
Rohrbaugh describes Sunshine as a distributed company, with the founders in New Zealand, headquarters in Australia and the CEO based in California. All of the C-Pulse components are manufactured by partners. Polymer Technology Group (Berkeley California) makes the durable biomaterials for components of the cuff and the electronics are made by Plexus (Neenah, Wisconsin).
C-Pulse is Sunshine's only product in development. With a potential price tag of $50,000, the device will obviously make or break the company.
"We have enough cash to carry us forward through this trial, Rohrbaugh said. "We will seek additional financing in the first part of next year."
In addition to FDA approval for the IDE, the company was issued a CMS category B, making reimbursement available for the procedures during the trial.