Phase 2 Trial Begins for Bolton Medical's RelayPro to Treat Thoracic Aortic Dissections
October 3, 2017—Bolton Medical, Inc. announced that the first patient has been enrolled in the RelayPro phase 2 clinical trial for treatment of acute complicated type B thoracic aortic dissections.
The first procedure was performed by cardiothoracic surgeon Christian Shults, MD, and vascular surgeon Tareq Massimi, MD, at Washington Hospital Center in Washington DC. The trial's National Principal Investigator is Edward Woo, MD, Chief of Vascular Surgery at MedStar Washington Hospital in Washington, DC.
This trial will assess the safety and efficacy of the company's RelayPro thoracic stent graft to treat patients with type B dissections.
RelayPro is a low-profile, next-generation stent graft system designed for the treatment of complex thoracic disease in the United States. Bolton Medical is currently pursuing additional indications for thoracic aneurysm and transection for RelayPro in the United States through separate clinical trials and anticipates approval with a full suite of indications.
RelayPro will be offered to United States physicians in both nonbare stent (NBS) and bare stent configurations for the treatment of descending thoracic aneurysms, type B dissections, and blunt traumatic aortic injury. Bolton Medical's NBS technology features a fully covered proximal end that is clasped to the delivery system to provide optimal control and accuracy.
In the company's announcement, Dr. Shults commented, “The patient’s anatomy and disease state made the case especially challenging. For this case, I selected the RelayPro’s NBS 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.” Dr. Massimi added, “It was a very challenging case, but the control and accuracy of RelayPro was just right for it.”
In April 2017, Bolton Medical was acquired by Vascutek Terumo after a definitive agreement announced in January.