A cardiac medical device from Sunshine Heart that uses a balloon to assist the heart in pumping blood has shown promise in a clinical trial led by Ohio State University Medical Center (OSUMC).
Patients enrolled in a multicenter North American clinical trial of Eden Prairie, Minnesota-based Sunshine Heart’s C-Pulse heart-assist system saw improvement in a number of indicators, according to a statement from OSUMC.
“The trial results to date show positive trends of efficacy with a strong safety profile as compared to later stage mechanical support devices,” said Dr. William T. Abraham, director of the division of cardiovascular medicine at OSUMC, and national co-lead principal investigator of the study.
The results of the trial, if confirmed via further study, help validate the company’s technology and push it farther down the path to regulatory clearance or approval.
Sunshine Heart plans to file a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration in the fourth quarter, CFO Jeff Mathiesen said. If the application is approved, the company would have the legal right to begin marketing the device.
Sunshine Heart’s C-Pulse system is an implantable, nonblood-contacting heart-assist therapy to treat moderate to severe heart failure. The device is designed to relieve heart failure symptoms through balloon counter-pulsation technology that helps the heart by reducing the workload of the left ventricle. The balloon inflation and deflation is designed to synchronize with a patient’s heartbeat, akin to a pacemaker.
Patients in the seven-center trial had a median length of hospital stay of eight days.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In July, Sunshine Heart raised $5 million by selling 115 million shares in a private placement with institutional investors in the U.S. and Canada. The company’s shares are listed on the Australian Stock Exchange. At the time, the company said it planned to raise an additional $10 million to pay for clinical trials and to develop a fully implantable wireless version of C-Pulse.
Dr. William Peters, an Australian cardiologist who also trained at Stanford University, invented the C-Pulse technology.
