DC Devices Becomes Corvia Medical, Completes REDUCE LAP-HF Enrollment

June 22, 2015—DC Devices, Inc., which has changed its name to Corvia Medical, Inc., announced that it has completed enrollment and implant procedures in the REDUCE LAP-HF trial. REDUCE LAP-HF is an open-label, multicenter, single-arm study of the company’s transcatheter interatrial shunt device (IASD) for the treatment of diastolic heart failure, also known as heart failure with preserved ejection fraction.

The Corvia IASD system reduces pressure in the heart by allowing blood to flow between the left and right atria. When the device is implanted, a small passage is formed between the left and right atria so blood can flow between the two chambers, potentially lowering pressure in the left atrium to reduce the symptoms of heart failure. The IASD system is not available for investigational use or for commercial distribution in the United States.

According to the company, the REDUCE LAP-HF trial is designed to evaluate the safety and performance of the IASD system in the treatment of heart failure for patients with preserved or mildly reduced ejection fraction who have elevated left atrial pressure and remain symptomatic despite appropriate medical management. The trial enrolled 64 patients who received implants of the device at 18 centers in 11 countries. The primary safety endpoint is device-related major adverse cardiac and cerebrovascular events and systemic embolic events through 6 months postimplantation.

The trial’s Principal Investigator is Prof. Chris Hayward, MD, who is Senior Staff Cardiologist in the Heart Failure and Transplant Unit at St. Vincent’s Hospital in Sydney, Australia.

In the company’s announcement, Prof. Hayward, commented, “We have treated 10 patients with the IASD system and are very pleased with the results. Many of our patients have been able to return to activities they had previously abandoned, with improvement in their exercise capacity and heart failure symptoms."

Coinvestigator David Muller, MD, who is Director of the cardiac catheterization laboratory at St. Vincent's Hospital, added, “The system is elegant and I found it extremely easy to use. We have seen substantial benefit in individuals who were previously very symptomatic. I look forward to offering this treatment to more of my patients.”