Medtronic expands availability of aortic and peripheral solutions to US market


Medtronic has announced that two recently US Food and Drug Administration (FDA)-approved devices will be featured at the Society for Vascular Surgery’s 2014 Vascular Annual Meeting (5–7 June; Boston, USA). Valiant Captivia thoracic stent graft system proximal FreeFlo tapers line extension now with dissection indication, and the TOTAL across crossing support catheter for peripheral artery disease in the below-the-knee vessel bed are now available to physicians in the United States.

Valiant Captivia Tapers for Dissection

The Valiant Captivia system proximal FreeFlo tapers line extension is now indicated in the USA for the treatment of thoracic aortic dissections, offering physicians increased patient applicability for fragile tapered, dissected aortas. Thoracic aortic dissection is a condition associated with high morbidity and mortality in which the upper segment of the aorta is torn along the innermost layer of the vessel wall.

“There is a growing body of evidence in support of endovascular repair for thoracic aortic dissection as a minimally invasive alternative to open surgical repair and even medical therapy alone,” says Joseph Bavaria, professor of surgery and director of the thoracic aortic surgery programme at the University of Pennsylvania in Philadelphia, USA, and a national principal investigator for the Medtronic DISSECTION trial. “The Valiant Captivia system has undoubtedly demonstrated safety and efficacy in the treatment of acute type B dissection cases with excellent technical success.”

In January, Medtronic initially introduced its 11 new proximal FreeFlo tapered pieces to the Valiant Captivia system. The expanded size matrix enables physicians to treat thoracic pathologies in tapered aortas, increasing the configuration possibilities by 30% to allow for effective treatment of a wider range of patient anatomies.

“In aortic dissection, the aorta tapers significantly,” explains Jean Panneton, vascular surgery chief and programme director at Eastern Virginia Medical School. “The new Valiant Captivia tapered pieces are ideal for treating these challenging cases, because they offer customisable options. This allows optimal graft sizing that can lead to better procedural outcomes for patients with dissected aortas.”

TOTAL across crossing support catheter

The TOTAL across crossing support catheter has been designed to address specific challenges typically encountered by physicians treating patients with critical limb ischaemia caused by below-the-knee lesions. It is intended to facilitate access of challenging lesions below the knee by allowing enhanced support for guide wire advancement, as well as guide wire exchange and selective angiography capabilities. It is the only 0.014″ guidewire compatible crossing support catheter made of a spiral cut stainless steel hypotube that combines exceptional full-length push response with distal flexibility. Moreover the unparalleled catheter X-ray visualisation, and its 2F tapered tip allows easy access and precise positioning in the most difficult distal lesions. TOTAL across has CE mark approval and recently received US FDA 510(k) clearance.

Anvar Babaev, interventional cardiologist at NYU Langone Medical Center, performed one of the first US cases with the TOTAL across crossing support catheter.

“Critical limb ischaemia with below-the-knee chronic occlusion is a particularly challenging subset of patients to treat, and this patient was no exception having occluded, severely calcified distal anterior tibial artery and large non-healing foot ulcer,” says Babaev. “I chose to use the TOTAL across crossing support catheter, which enabled successful crossing and recanalisation of the very difficult lesion with pushability and support I had not experienced before.”