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Noticias
MINNEAPOLIS -- Jun. 4, 2014 -- Continuing to expand its market-leading portfolio ofendovascular solutions, Medtronic, Inc. (NYSE: MDT) announced today that tworecently Food and Drug Administration (FDA) approved devices will be featuredat the Society for Vascular Surgery's 2014 Vascular Annual Meeting, takingplace June 5-7 in Boston. Valiant Captivia Thoracic Stent Graft systemproximal FreeFlo tapers line extension now with dissection indication, and theTOTAL across crossing support catheter for peripheral artery disease (PAD) in thebelow-the-knee (BTK) vessel bed are now available to physicians in the UnitedStates.
Valiant Captivia Tapers for Dissection
The Valiant Captivia System proximal FreeFlo tapers line extension is nowindicated in the U.S. for the treatment of thoracic aortic dissections,offering physicians increased patient applicability for fragile tapered,dissected aortas. Thoracic aortic dissection is a condition associated withhigh morbidity and mortality in which the upper segment of the aorta is tornalong the innermost layer of the vessel wall.
'There is a growing body of evidence in supportof endovascular repair for thoracic aortic dissection as a minimally invasivealternative to open surgical repair and even medical therapy alone,' saidJoseph Bavaria, MD, professor of surgery and director of the thoracic aorticsurgery program at the University of Pennsylvania in Philadelphia, and anational principal investigator for the Medtronic DISSECTION Trial. 'TheValiant Captivia system has undoubtedly demonstrated safety and efficacy in thetreatment of acute type B dissection cases with excellent technicalsuccess.'
In January, Medtronic initially introduced its 11 newproximal FreeFlo tapered pieces to the Valiant Captivia system. The expandedsize matrix enables physicians to treat thoracic pathologies in tapered aortas,increasing the configuration possibilities by 30 percent to allow for effectivetreatment of a wider range of patient anatomies. With the addition ofdissection indication for the tapers line extension, Medtronic's market-leadingthoracic solutions portfolio is now broadly indicated to treat diseases in thethoracic aorta.
'In aortic dissection, the aorta taperssignificantly,' explained Dr. Jean Panneton, vascular surgery chief andprogram director at Eastern Virginia Medical School. 'The new ValiantCaptivia tapered pieces are ideal for treating these challenging cases, becausethey offer customizable options. This allows optimal graft sizing thatcan lead to better procedural outcomes for patients with dissectedaortas.'
TOTAL across crossing support catheter
The TOTAL across crossing support catheter has been designed to addressspecific challenges typically encountered by physicians treating patients withcritical limb ischemia (CLI) caused by BTK lesions. It is intended tofacilitate access of challenging lesions below the knee by allowing enhancedsupport for guide wire advancement, as well as guide wire exchange andselective angiography capabilities. It is the only 0.014' guidewirecompatible crossing support catheter made of a spiral cut stainless steelhypotube that combines exceptional full-length push response with distalflexibility. Moreover the unparalleled catheter X-ray visualization, andits 2F tapered tip allows easy access and precise positioning in the mostdifficult distal lesions. TOTAL across has CE (Conformité Européene) mark andrecently received U.S. FDA 510(k) clearance.
Dr. Anvar Babaev, interventional cardiologist at NYULangone Medical Center, performed one of the first U.S. cases with the TOTALacross crossing support catheter.
'Critical limb ischemia with below the kneechronic occlusion is a particularly challenging subset of patients to treat,and this patient was no exception having occluded, severely calcified distalanterior tibial artery and large non-healing foot ulcer,' said Dr. Babaev.'I chose to use the TOTAL across crossing support catheter, which enabledsuccessful crossing and recanalization of the very difficult lesion withpushability and support I had not experienced before.'
The TOTAL across crossing support catheter expandsMedtronic's product portfolio of medical devices used to treat peripheralartery disease (PAD) and is an example of the company's focus on developinginnovative lesion-specific solutions for PAD. Along with the Amphirion Plus andAmphirion Deep PTA Balloon Catheters - the addition of TOTAL across crossing supportcatheter represents a comprehensive solution portfolio for BTK interventions.It is the first of three new products to address the clinical challenge of BTKCLI 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 addressthe clinical challenges associated with the treatment of lower extremitydisease.
In collaboration with leading clinicians, researchersand scientists, Medtronic offers the broadest range of innovative medicaltechnology for the interventional and surgical treatment of cardiovasculardiseases and cardiac arrhythmias. The company strives to offer products andservices that deliver clinical and economic value to healthcare consumers and providers worldwide.