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Título: Bolton Medical initiates Regeneration: The International Clinical Trial for Relay PRO and Relay NBS PRO Aortic Stent-Grafts
Fecha: 27-10-2014
BARCELONA, SPAIN - (Oct. 27th, 2014) - Bolton Medical, a medical device manufacturer that specializes in endovascular treatments for aortic pathologies, announced today it has performed its first in-human implantation of its Relay PRO device. The Relay PRO Thoracic Stent- Graft System will enhance the minimally-invasive treatment of patients with thoracic disease due to the lower profile of the delivery device. The first case was performed by Gianfranco Fadda, MD, Director of Vascular Surgery Department at Ospedale San Francesco, Nuoro in Italy.
Dr. Fadda was very pleased with the performance of the Relay PRO device, in the navigation of the femoral arteries and the stability of the device deployment, both of which are key factors for a successful outcome. Due to the low 19F profile of the delivery system, Dr Fadda was able to complete this case through a percutaneous approach, which eliminates the need for an open incision in the groin.
The Regeneration study is led by Vinçenc Riambau, MD at Hospital Clínic de Barcelona. The primary objective of the clinical study is to assess the safety and effectiveness of the Relay PRO and Relay NBS PRO in subjects with thoracic aortic pathologies. The Regeneration study will enroll patients at the following institutions: Hospital Clínic de Barcelona, Hospital Germans Trias i Pujol, Badalona, Hospital Marqués de Valdecilla, Santander,
Azienda Ospedaliera "S. Giovanni - Addolorata", Roma, Ospedale San Francesco Nuoro, and Centro Cardiologico Monzino IRCCS, Milan, located in Spain and Italy. Results of this study will support the approval of the product for CE-Mark registration.
COMPANY Bolton Medical currently manufactures Relay Plus and Relay NBS Plus Thoracic Stent-Grafts and Treovance Abdominal Stent-Grafts. They are indicated for the endovascular treatment of aortic pathologies such as aneurysms, dissections, penetrating ulcers, pseudoaneurysms, and intramural hematomas. Since 2005, more than 11,000 patients have been treated with Relay and Relay NBS Stent-Grafts worldwide.
Bolton Medical is a privately-held company, with international operations based in Barcelona, Spain, and U.S. operations in Sunrise, Florida. Bolton Medical is a wholly-owned subsidiary of Werfen Life, a diverse manufacturer and supplier of products for the medical industry. www.boltonmedical.com
Fuente: endovascular.es

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