Bolton Medical Begins Phase 2 Trial for RelayPro to Treat Descending TAA
May 16, 2017—Bolton Medical announced that the first patient has been enrolled in the RelayPro US Food and Drug Administration (FDA) phase 2 clinical trial, which is designed to study the safety and effectiveness of the company's RelayPro thoracic stent graft system as a treatment for endovascular repair of descending thoracic aortic aneurysms (TAA). The first implantation in the trial was performed by Joseph Flack, MD, at Baystate Medical Center in Springfield, Massachusetts.
In the company's press release, Dr. Flack commented, "For the first United States implantation, we used RelayPro in a small, 61-year-old woman with severe chronic obstructive pulmonary disease. She had challenging access, and we found that the system performed with no problem and allowed us to have a great outcome. We look forward to using this device in the trial." Dr. Flack is assistant professor of surgery at Tufts University School of Medicine in Boston, Massachusetts.
The trial's Co-National Principal Investigators are Wilson Szeto, MD, and Venkatesh Ramaiah, MD. Dr. Szeto is Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center in Philadelphia, Pennsylvania. Dr. Ramaiah is Medical Director, Vascular Surgery, Arizona Heart Hospital in Phoenix, Arizona.
According to Bolton Medical, RelayPro is the latest addition to the Relay thoracic stent graft family. The device features a low outer profile of 19 to 23 F. It is designed to help facilitate treatment of descending TAA, even in cases with difficult access. RelayPro is available in both bare-stent and non-bare–stent configurations. Results from the RelayPlus FDA phase 2 trial showed a low incidence of stroke, stent fractures, and type 1 endoleaks, stated the company.
In April 2017, Bolton Medical was acquired by Vascutek Terumo after a definitive agreement announced in January.