Sunshine Heart (Sydney, Australia) is seeking to initiate an Investigational Device Exemption feasibility trial for its C-Pulse device, a non-blood-contacting heart therapy for patients with moderate to severe heart failure. The company reported passing a five-year milestone on the durability testing of the device last Wednesday.
"Right now we're into the normal question-and-answer phase of the [IDE] process with the FDA," Sunshine Heart CEO Don Rohrbaugh told Medical Device Daily. "But we hope to be able to enroll our first U.S. patient in clinical trials sometime this year."
The company, has six clinical trial sites planned that include Ohio State University Heart Center (Columbus), Northwestern University Fineberg School of Medicine (Chicago), Penn State Milton S. Hershey Medical Center (Hershey, Pennsylvania), University of Louisville Jewish Hospital (Louisville, Kentucky), University of Alabama at Birmingham and the University of Florida (Gainesville).
Previously Sunshine reported that William Abraham, MD, of Ohio State Heart Center, and Patrick McCarthy, MD, of Northwestern University Feinberg School of Medicine, would be the co-principal investigators for the C-Pulse feasibility trial.
"These are very talented people — we have an outstanding team," Rohrbaugh said. "Dr. Abraham was once the lead principal investigator for Medtronic (Minneapolis). So we've got a tremendous amount of talent."
He added that C-Pulse "is exceptional. Through this device, we're helping the heart pump blood without ever coming in contact with the blood."
C-Pulse uses a standard pacemaker lead, a single soft percutaneous line and an external pneumatic battery-operated driver. The driver unit, which resembles a Walkman or portable CD player, 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.
Implantation is performed through a simple surgery on a beating heart, without the need for heart-lung bypass or any incisions to the heart or great vessels.
This is how the device works. A balloon found in the cuff is inflated and deflated in time with the heart rhythm to improve blood supply to the body and to the heart muscle itself, as well as serving to reduce the workload of the heart. A sensing lead conveys the heart's electrical signals to the driver unit. As a result, the balloon in the cuff inflates and deflates with the heart's rhythm creating a counterpulsation action.
This counterpulsation action forces the blood out of the ascending aorta and assists the heart in pumping blood more efficiently.
Sunshine Heart partnered with Polymer Technology Group (PTG; Berkeley California), a biomaterials company, to come up with durable biomaterials for components of the device.
"Our relationship with PTG started back in 2004, when we needed a high-quality material for the balloon," Rohrbaugh said.
PTG supplied the company with BioSpan for the balloon, a segmented polyether urethane (SPU) that is used in the majority of clinical ventricular assist devices and artificial heart cases worldwide. It also used Bionate, a thermoplastic polycarbonate urethane (TPU) for the tubing of the device.
BioSpan is characterized by high strength, flexibility and fatigue resistance. PTG developed BioSpan in response to the crisis created by the withdrawal of Biomer by Ethicon (Somerville, New Jersey) a Johnson & Johnson (New Brunswick, New Jersey) company.
Bionate is a thermoplastic elastomer formed as the reaction product of a hydroxyl terminated polycarbonate, an aromatic diisocyanate, and a low-molecular-weight glycol used as a chain extender. It is used in devices such as pacemaker leads, ventricular assist devices, catheters and stents. They also are extensively used in orthopedic applications for their tough, load bearing qualities. Bionate TPUs are stable to dry heat, as well as Gamma sterilization.
C-Pulse doesn't yet have the CE mark.
"A lot of people go after [the CE mark] like it's the Holy Grail, but we are not running a separate clinical study for Europe," Rohrbaugh said. "We'll just use the clinical study from the U.S. once it's completed."
To date, both companies are enjoying a measure of success.
PTG reported launching its spin-off of a life sciences incubator, Emergence (also Berkeley).
Emergence will have access to PTG's staff and facilities for synthesis, characterization, processing, regulatory approval and manufacturing resources in the development of new devices, PTG said.
"We're excited about it, we've also just expanded our center here in Berkeley," Robert Ward, president/CEO of PTG, told MDD.
Sunshine Heart, which was founded by William Peters, MD, in 2000 and has emerged from a small virtual company, said that it was still riding high from key funding it received a few years ago.
"The company is funded by Australia & New Zealand Venture Capital. Our market capitalization is $25 million and we raised $15 million of that from an IPO in Australia [in 2005]," Rohrbaugh said.
C-Pulse was developed by Peters, working on a theory that those with heart failure needed support rather than replacement.
To date Sunshine Heart's primary offering is the C-Pulse.