The first patient has been enrolled in Bolton Medical’s RelayPro US Food and Drug Administration (FDA) Phase II clinical trial.
This study will assess the safety and efficacy of RelayPro to treat Type B dissections.
Christian Shults, cardiothoracic surgeon and Tareq Massimi, vascular surgeon, Washington Hospital Center, Washington DC, USA performed the procedure. The trial National Principal Investigator is Edward Woo, chief of Vascular Surgery, MedStar Washington Hospital, Washington DC, USA.
“The patient’s anatomy and disease state made the case especially challenging. For this case I selected the RelayPro’s non-bare stent configuration because of the fully covered proximal end. RelayPro performed ideally and the case went very well. We were able to nail the targeted proximal and distal landing zones, which is key in these cases,” says Shults. “It was a very challenging case, but control and accuracy of RelayPro was just right for it,” says Tareq Massimi.
Bolton Medical is currently pursuing additional indications for thoracic aneurysm and transection for RelayPro in the US through separate clinical trials, and anticipates approval with a full suite of indications. RelayPro will offer US physicians both non-bare stent and bare-stent configurations for treatment of descending thoracic aneurysms, type B dissections, and blunt traumatic aortic injury (BTAI).
“We are excited to be able to introduce the NBS technology to the US market as it has been a leading device in Europe for the past several years,” says Paul Kuznik, chief executive officer of Bolton Medical.
Bolton is part of the Terumo Corporation. Terumo announced the acquisition the start of this year.