These devices are supplied sterile for single use only. Caution: Implantation of the Medtronic CoreValve™ Evolut™ R system should be performed only by physicians who have received Medtronic CoreValve™ Evolut™ R training. See how the external tissue wrap on the Evolut PRO TAV performs. These devices are supplied sterile for single use only. In 2016, Medtronic launched its third-generation (Evolut PRO) TAVR system with recapturable and repositionable capabilities and advanced sealing. The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System each consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. Compression Loading System . The Evolut TM PRO system features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The former was approved under P130021/S014 (for sizes 23, 26, and 29 mm) and P130021/S025 (for size 34 mm) on June 22, 2015, and October 26, 2016, respectively; the latter was approved under P130021/S029 on March 20, 2017. With CoreValve and Evolut TAVR, a small incision is made in the leg, neck or chest and a thin, flexible tube (catheter) holding the new aortic heart valve is guided to the heart by the physician using imaging and a delivery system and then positioned by the physician within the diseased aortic valve. The Evolut PRO system design has one important addition — an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. The next generation Evolut TM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics — allowing your patients to return to activity faster. DOWNLOAD BROCHURE Caution: Implantation of the Medtronic CoreValve™ Evolut™ R system should be performed only by physicians who have received Medtronic CoreValve™ Evolut™ R training. The CoreValve Evolut R System and the CoreValve Evolut PRO System are design iterations of the CoreValve System. Manufacturing the CoreValve Evolut R TAV See the Evolut TAVI manufacturing process and our commitment to quality in every step. Meet the Evolut PRO System. Delivery Catheter System . The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting. CoreValve™ Evolut™ R System . The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The current supplement was submitted to expand … These devices are supplied sterile for single use only. CoreValve™ Evolut™ R Transcatheter Aortic Valve . The EnVeo TM PRO delivery system assists in accurate positioning of the valve. Background . EVOLUT PRO+ SYSTEM Transcatheter Aortic Valve Replacement (TAVR). The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. These devices are supplied sterile for single use only. The Evolut TM PRO system is the next-generation, self-expanding transcatheter aortic valve with exceptional design and advanced sealing capability. The Evolut PRO system goes beyond the CoreValve™ and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. EnVeo PRO Delivery System. CoreValve™ System Transcatheter Aortic Valve Delivery Catheter System Compression Loading System Caution: Implantation of the Medtronic CoreValve™ system should be performed only by physicians who have received Medtronic CoreValve™ training. Recapture and reposition The EnVeo TM PRO delivery system assists in accurate positioning of the valve. Loading System. The Enveo R Delivery System with 14Fr-Equivalent In-Line Sheath is indicated for vessels down to 5.0 mm Evolut R DCS 12 CoreValve and Evolut R Systems Overview | Medtronic - Confidential DELIVERY CATHETER SYSTEMS The 18 Fr CoreValve Accutrak Delivery system is indicated for vessels down to 6.0 mm CoreValve DCS CAUTION: Implantation of the Medtronic CoreValve™ system should be performed only by physicians who have received Medtronic CoreValve™ training. The Medtronic CoreValve™ system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤0.8 cm 2 , a mean aortic valve gradient of >40 mm Hg, or a peak aortic-jet velocity of 1,2,3 . With CoreValve and Evolut TAVR, a small incision is made in the leg, neck or chest and a thin, flexible tube (catheter) holding the new aortic heart valve is guided to the heart by the physician using imaging and a delivery system and then positioned by the physician within the diseased aortic valve. Delivery Catheter System . Lowest delivery profile The Evolut TM PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. Manufacturing process and our commitment to quality in every step see the Evolut TM PRO+ transcatheter aortic valve system industry-leading... 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