W. L. Gore to distribute QXMédical's Q50 Stent Graft Balloon Catheter

W. L. Gore & Associates (Gore) today announced it has entered into a partnership with QXMédical, LLC, a medical device development and marketing company. As part of the agreement, Gore will distribute the Q50 Stent Graft Balloon Catheter which is designed for use with aortic stent grafts that treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). The US Food and Drug Administration (FDA) cleared the catheter for marketing in October 2009. This partnership allows Gore to provide customers with a balloon catheter for modeling and occlusion use with the GORE EXCLUDER^® AAA Endoprosthesis and all other aortic stent grafts.

“We are pleased to enter into this partnership with Gore and excited about the opportunity to bring the Q50 Stent Graft Balloon Catheter to more physicians and their patients,” stated Frank Panarello, president of QXMédical. “We believe the Q50 Stent Graft Balloon Catheter ideally complements the GORE EXCLUDER AAA Endoprosthesis and feel that, used together, the devices are best-in-class for facilitating endovascular aneurysm repair.”

The QXMédical device is a full occlusion balloon catheter that helps aortic stent grafts to fully expand and seal in vessel diameters ranging from 10 – 50 mm. It offers a short, flexible tip that increases trackability through challenging anatomy, and a compliant polyurethane balloon that inflates and deflates rapidly to give physicians more control. The Q50 Stent Graft Balloon Catheter offers the broadest inflation diameter range available on the market and is compatible with standard 0.035" guidewires and low-profile 12 Fr introducer sheaths. With 65 and 100 cm length pushable catheter shafts in an 8 Fr diameter, the device accommodates both abdominal and thoracic applications.

“Our partnership with QXMédical allows Gore to offer physicians the broadest diameter range with the lowest available profile aortic modeling balloon on the market,” said David Abeyta, Aortic Business Unit Leader at Gore. “Here at Gore, our commitment is to improve patient care, and this agreement underscores our dedication to providing the clinical community with the most sophisticated, minimally invasive alternatives to traditional treatment methods. The Q50 Stent Graft Balloon Catheter perfectly complements the GORE EXCLUDER AAA Endoprosthesis to help prevent aneurysm rupture while removing the need for invasive surgery.”

Abdominal aortic aneurysm is the 13^th leading cause of death in the United States. Each year, approximately 200,000 people are diagnosed with the condition, which is characterized by the swelling or ballooning of the abdominal aorta. In 15,000 of those cases, AAA is severe enough to cause death from its rupture if not treated; however, when diagnosed early, AAAs can be treated safely and effectively.

Traditional surgical treatment requires a large incision to place a synthetic graft to repair the diseased artery. This method can result in long hospital stays and painful recoveries. The GORE EXCLUDER AAA Endoprosthesis, in contrast, uses a minimally invasive endovascular procedure, thereby reducing the hospital stay, morbidity and short-term mortality associated with surgery.