endovascular.es

Título: First Patient Enrolled in GORE® TAG® Thoracic Branch Endoprosthesis Early Feasibility Study
Fecha: 28-04-2015
FLAGSTAFF, Ariz. & LONDON--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announcedthat Michel Makaroun, MD, co-director of the University of Pittsburgh MedicalCenter (UPMC) Heart and Vascular Institute and the chair and professor ofsurgery in the division of vascular surgery, enrolled the first brachiocephalictreated patient in the GORE® TAG® Thoracic Branch Endoprosthesis EarlyFeasibility Study. The US-based study will assess the treatment of aortic archaneurysms in which perfusion of the brachiocephalic or left common carotidartery is maintained through a branch device.
“Working with Gore on this early feasibility study gives usthe opportunity to explore the GORE TAG Thoracic Branch Endoprosthesis as apotentially new less invasive treatment option that will greatly benefit thispatient population.”
Principal Investigator of the study, Michael Dake, MD,Thelma and Henry Doelger Professor of cardiovascular surgery at the StanfordSchool of Medicine, will present on the study this week at the Charing Cross(CX) International Symposium in London. The study represents Gore’s first useof a recent Food and Drug Administration (FDA) early feasibility study guidanceto help patients gain access to breakthrough medical devices in order tomaintain innovation of new technologies in the US.
“Aortic arch aneurysms present physicians with a verydifficult challenge, as no other approved endovascular method exists to treatthis region,” said Dr. Makaroun. “Working with Gore on this early feasibilitystudy gives us the opportunity to explore the GORE TAG Thoracic BranchEndoprosthesis as a potentially new less invasive treatment option that willgreatly benefit this patient population.”
Currently, treatment of aortic arch aneurysms is performedeither through complex open surgical repair or through hybrid proceduresinvolving the combination of devices whose use in this application has yet tobe approved by the FDA and still requires a thoracotomy or incision of thesternum. In contrast to these alternatives, the GORE TAG Thoracic BranchEndoprosthesis offers a less invasive treatment option specifically designedfor these challenging cases.
“Over the course of my career, I have witnessed a sustainedfocus on the development of less invasive approaches to aortic archaneurysms,” said Dr. Dake. “This clinical trial represents a culmination ofyears of research and development, beginning with the custom fabrication of adevice to meet a specific patient's anatomy and now reaching a more practicaloff-the-shelf solution, which I am confident will improve outcomes forpatients.”
Designed for long-term durability, the GORE TAG ThoracicBranch Endoprosthesis is an off-the-shelf device, which includes aortic andbranch components constructed specifically for use in the arch. The deviceallows for femoral-only access over a pre-positioned branch guidewire designedto minimize the risk of branch vessel coverage and improve ease ofimplantation. The branch device also features the CBAS® Heparin Surface. Thistechnology, used in many of Gore’s peripheral products, is intended to provideimproved thromboresistance within the branch component of the device.
“This feasibility study is a testament to our longstandingcommitment to innovation in new products and pathways, and to bringing productsto market quickly,” said Ryan Takeuchi, Gore Aortic Business Leader. “We arethe first to investigate this indication with an off-the-shelf endovasculardevice. We are meeting this challenge using our aortic branch portfolio toaddress this new and rather difficult clinical application.”
Gore has met several other key milestones in its commitmentto pursuing new clinical applications with its aortic branch and thoracicportfolio. In 2014, Gore initiated a clinical study evaluating the use of theGORE TAG Thoracic Branch Endoprosthesis for the treatment of thoracic aorticaneurysms that require coverage of the left subclavian artery (LSA). Gore alsoenrolled its first patient in the Gore Thoracoabdominal Aortic AneurysmClinical Study, which will assess the durable repair of aortic aneurysmsencroaching on or involving visceral branch vessels using the GORE® EXCLUDER®Thoracoabdominal Branch Endoprosthesis. Enrollment in the Gore® EXCLUDER® IliacBranch Clinical Study was completed in February 2015. Additionally, the FDAapproved the Conformable GORE® TAG® Thoracic Endoprosthesis for thetreatment of acute and chronic dissections in September 2013, making it thefirst stent-graft approved to treat aneurysms, traumatic transections, and TypeB dissections of the thoracic aorta.
Visit the Gore aortic portal for additional information.
ABOUT US
At Gore, we have provided creative therapeutic solutions tocomplex medical problems for more than 35 years. During that time, more than 35million innovative Gore Medical Devices have been implanted, saving andimproving the quality of lives worldwide. Our extensive family of productsincludes vascular grafts, endovascular and interventional devices, surgicalmeshes for hernia and soft tissue reconstruction, staple line reinforcementmaterials, and sutures for use in vascular, cardiac, and general surgery. Weare one of a select few companies to appear on all of the US “100 BestCompanies to Work For” lists since the rankings debuted in 1984. For moreinformation, visit www.goremedical.com.
Products listed may not be available in all markets.GORE®, TAG®, EXCLUDER®, and designs are trademarks of W. L. Gore &Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly ownedsubsidiary of W. L. Gore & Associates.
Contacts
Chempetitive Group for W. L. Gore & Associates
Kena Hudson or Rachel Wallace
(510) 908-0966
GoreMedical@Chempetitive.com
Fuente: endovascular.es

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