Enrollment Begins in Trial of Bolton Medical's RelayPro for Treatment of Blunt Traumatic Aortic Injury
December 5, 2017—Bolton Medical, Inc. announced that the first patient has been enrolled in the US Food and Drug Administration phase 2 clinical trial of the company's RelayPro in treating blunt traumatic aortic injury. The procedure was performed by Peter Rossi, MD, who is Associate Professor of Vascular Surgery at Froedtert Hospital & the Medical College of Wisconsin in Milwaukee, Wisconsin.
The trial's Co-National Principal Investigators are Ravi Rajani, MD, Associate Professor of Vascular Surgery and Cardiology at Emory University School of Medicine in Atlanta, Georgia, and Benjamin Starnes, MD, Professor and Chief of Vascular Surgery at University of Washington School of Medicine in Seattle, Washington.
In the company's announcement, Dr. Starnes commented, "I’m excited to hear that Bolton’s technology has been successfully used to treat a patient suffering from acute transection of the thoracic aorta. This is a game-changing technology for this application.” Dr. Rajani added, “Congratulations to Dr. Peter Rossi and his team at Froedtert Hospital for treating the first patient in the RelayPro transection case. We are happy to report that despite being severely injured, the patient is doing well after successful device implantation. It is exciting to see how quickly other enrolling sites are nearing initiation of this important trial.”
According to the company, RelayPro is a low-profile, next-generation stent graft system designed for treating more complex thoracic diseases. RelayPro will introduce the company's nonbare stent (NBS) technology to the United States market. The NBS features a fully covered proximal end that is clasped to the delivery system to provide optimal control and accuracy.
Bolton Medical, which joined the Vascutek Terumo family of companies in April, is pursuing US Food and Drug Administration approval of indications for treating descending thoracic aortic aneurysms, acute complicated type B thoracic aortic dissections, and blunt traumatic aortic injuries through three separate trials.