Sunrise, Fla, October 3, 2017 – Bolton Medical announced the first patient has been enrolled in the RelayPro FDA Phase II Clinical Trial for Treatment of Acute Complicated Type B Thoracic Aortic Dissections. This trial will assess the safety and efficacy of RelayPro to treat Type B dissections. Christian Shults, M.D., Cardiothoracic Surgeon and Tareq Massimi, M.D., Vascular Surgeon, Washington Hospital Center, Washington D.C. performed the procedure. The trial National Principal Investigator is Edward Woo. M.D., Chief of Vascular Surgery, MedStar Washington Hospital.
“The patient’s anatomy and disease state made the case especially challenging. For this case, I selected the RelayPro’s NBS (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,” said Christian Shults, M.D. “It was a very challenging case, but the control and accuracy of RelayPro was just right for it,” said Tareq Massimi, M.D.
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 NBS (Non-Bare Stent) and Bare-Stent configurations for treatment of descending thoracic aneurysms, type B dissections, and blunt traumatic aortic injury (BTAI).
“The investment in 3 US clinical trials is a testament to our commitment to providing real solutions for complex aortic pathologies. 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. I couldn’t be more proud of our Bolton Medical team and our physician partners for helping us pursue our vision of becoming a leading aortic company, ” said Paul Kuznik, CEO of Bolton Medical, part of the Terumo Corporation.
About RelayPro
RelayPro is a low profile next-generation Stent-Graft system designed for treatment of more complex thoracic disease in the US. RelayPro will introduce Bolton Medical’s NBS (Non-Bare Stent) technology to the US market. The NBS features a fully covered proximal end that is clasped to the delivery system to provide optimal control and accuracy. This addition to the Relay family will provide physicians with more options when treating challenging pathologies like aortic dissections and BTAI. RelayPro will also provide an enhanced portfolio with more tapers and lengths to allow treatment for patients with unique aortic anatomies.
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Megan Eckerman, Vice President of Marketing
Latoya Spencer, Marketing Communication Manager
