Medtronic has announced that two recently Food and Drug Administration (FDA) approved devices will be featured at the Society for Vascular Surgery's 2014 Vascular Annual Meeting, taking place from 5 June to 7 June in Boston.
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 (PAD) in the below-the-knee (BTK) vessel bed are now available to physicians in the United States.
The Valiant Captivia System proximal FreeFlo tapers line extension is now indicated in the US 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.
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. With the addition of dissection indication for the tapers line extension, Medtronic’s market-leading thoracic solutions portfolio is now broadly indicated to treat diseases in the thoracic aorta.
The TOTAL across crossing support catheter has been designed to address specific challenges typically encountered by physicians treating patients with critical limb ischemia (CLI) caused by BTK 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 visualization, and its 2F tapered tip allows easy access and precise positioning in the most difficult distal lesions. TOTAL across has CE mark and recently received US FDA 510(k) clearance.
The TOTAL across crossing support catheter expands Medtronic’s product portfolio of medical devices used to treat peripheral artery disease (PAD) and is an example of the company’s focus on developing innovative lesion-specific solutions for PAD.
Along with the Amphirion Plus and Amphirion Deep PTA Balloon Catheters – the addition of TOTAL across crossing support catheter represents a comprehensive solution portfolio for BTK interventions. It is the first of three new products to address the clinical challenge of BTK CLI that Medtronic plans to introduce around the world over the next two years. It is the first of three new products Medtronic plans to introduce that address the clinical challenges associated with the treatment of lower extremity disease.