When Sunshine Heart (Tustin, California) sought an investigational device exemption (IDE) from the FDA last year to begin a feasibility trial of its C-Pulse heart assist device, the agency asked the company to pay special attention to female heart failure patients, CEO Don Rohrbaugh told Medical Device Daily.

"Even though half of the heart failure patients are women, in most clinical trials only 20% to 25% of enrollees are female," Rohrbaugh said.

Thus, the fact that one of the six sites participating in the company's trial, Jewish Hospital (Louisville, Kentucky) has completed implants of its C-Pulse heart assist system in two female patients, ages 55 and 58, respectively, is a significant milestone for the device, Rohrbaugh said. He noted that heart failure affects about 2.5 million women in the U.S.. The women were the first U.S. female patients treated with the C-Pulse device and they were the first two patients to receive the device at Jewish. Sunshine has treated a total of four patients thus far in the trial.

"C-Pulse can be an important new therapy for women suffering from heart failure since they typically survive longer than men with the disease but commonly have more illness, more frequent hospitalizations and a poorer overall quality of life," Rohrbaugh said.

The company received conditional approval from the FDA last year to begin the trial under an IDE (Medical Device Daily, Sept. 18, 2008). In April, the company reported that it had completed the first two implants of the device under the 20-person trial (MDD, April 22, 2009).

As for why women are typically underrepresented in heart failure trials, "it's a little bit of a puzzle," Rohrbaugh said. "Generally women have heart failure a little bit later in their life, although there are some women that get into heart failure early in life with postpartum heart failure ... there is some feeling that women don't recognize their symptoms as much as men, they go through hormonal changes which they attribute for their symptoms ..."

Another possible reason, he offered, is that women have a higher sensitivity to certain cancers, such as breast cancer, and therefore they may be less sensitive to the symptoms of heart failure. In any case, Sunshine Heart is making a concerted effort to ensure its trial represents a balance of men and women.

"On a whole, we've encouraged our sites to deliberately look for women maybe a little more carefully than they might have otherwise," Rohrbaugh said.

At Jewish, Mark Slaughter, MD, professor of surgery and chief of the Division of Thoracic and Cardiovascular Surgery at the University of Louisville, implanted the C-Pulse into the first two female patients. Slaughter also serves as the director of the Heart Transplant and Mechanical Assist Device program at Jewish Hospital and the University of Louisville and is the associate medical director of the Cardiovascular Innovation Institute (Louisville).

"It is an honor to have completed the first U.S. implants of the C-Pulse heart assist system in female heart failure patients," Slaughter said. "C-Pulse is highly innovative and implanted with a simple, low-risk minimally invasive surgical procedure. The device has the potential to offer a new therapy option for the treatment of advanced heart failure."

According to the company, the C-Pulse is an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. The device is designed to reduce the symptoms of heart failure through the use of counterpulsation technology, which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart's pumping load.

"In moderate heart failure, they're not sick enough for a heart transplant, they're not sick enough for an LVAD ... with our C-Pulse, it's a simple implant, non-blood contacting, patients don't have to go on anticoagulation drugs," Rohrbaugh said. "And because it's outside the blood stream and easy to implant it's a lower-risk procedure, lower-cost procedure, so that makes it attractive to the medical community – to treat these patients a little earlier, maybe give them a better quality of life."

According to Sunshine Heart, a major medical treatment challenge is that the medical regimen and CRT options often stop alleviating symptoms over time, hence the need for the C-Pulse.

"We are excited to be a part of the C-Pulse clinical trial in the U.S.," said Sumanth Prabhu, MD, professor of medicine and physiology and director of Heart Failure at the University of Louisville and co-principal investigator of the trial at Jewish Hospital. "The C-Pulse system is a novel device that increases blood flow to the body and to the heart muscle itself without coming into direct contact with the blood. Consequently, the risk of stroke and embolism appears to be negligible and blood thinning medication is not required."

Prabhu's research centers on understanding mechanisms underlying heart failure, Sunshine Heart noted.

In addition to Jewish and Ohio State, the 20-patient feasibility trial is being undertaken at four other U.S. medical institutions: Northwestern Memorial Hospital (Chicago), Hershey Medical Center (Hershey, Pennsylvania) of the Pennsylvania State University, University of Florida School of Medicine (Gainesville) and University of Alabama/Birmingham Medical Center.

Amanda Pedersen, 229-471-4212; amanda.pedersen@ahcmedia.com