COMMITTED FROM THE VERY START.
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1 COMMITTED FROM THE VERY START. Providing more cannula options for pediatric patients undergoing cardiopulmonary bypass, we can go Further, Together. Thirty-five years of cannula innovation. findyourideal.medtronic.com Important Safety Information Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgery procedures. For a listing of indications, contraindications, precautions, warnings, and potential adverse events please refer to the Instructions for Use. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 05/2017 UC EN
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5 Avalus Bioprosthesis Ordering and Specifications Avalus Valve Stent Internal Valve Order Size Diameter Orifice Number (TAD) Diameter External Valve Sewing Ring Profile Diameter Height Aortic Protrusion Avalus Bioprosthesis (1) (2) (3) (4) (5) mm 19 mm 17.5 mm 27.0 mm 13.0 mm 11.0 mm mm 21 mm 19.5 mm 29.0 mm 14.0 mm 12.0 mm mm 23 mm 21.5 mm 31.0 mm 15.0 mm 13.0 mm mm 25 mm 23.5 mm 33.0 mm 16.0 mm 14.0 mm mm 27 mm 25.5 mm 36.0 mm 17.0 mm 15.0 mm TAD Tissue Annulus Diameter Accessories Order Number Description 7420 Valve Handle 7400S Avalus Sizers T7400 Tray, Accessory, Avalus Avalus Demo Kit Indications: The Avalus bioprosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Contraindications: Do not use the valve if its use is not in the best interest of the patient. Evaluate all of the risks involved, including the anatomy and pathology observed at the time of surgery. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, stenosis, other), thromboembolism, and valve thrombosis. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eifus, consult instructions for use at Note: Manuals can be viewed using a current version of any major internet browser. DEMO KIT A Pericardial Replacement Valve Solution 2017 Medtronic. All Rights Reserved. UC EN 05/2017 medtronic.com
6 BACKED BY FACTS Medtronic Open Pivot Mechanical Heart Valves EXCELLENT CLINICAL PERFORMANCE In one of the largest, long-term aortic mechanical valve studies to date, * the Medtronic Open Pivot valve demonstrated spectacular performance in propensity-matched patient cohorts with zero incidences of structural valve failure at study endpoint and excellent freedom from adverse events. 9 Low INR Cohort Standard Cohort ** P-Value Mean INR P <0.001 Survival 1 year - 98% 5 year - 92% 10 year -79% 15 year - 63% 1 year - 91% 5 year - 79% 10 year - 63% 15 year - 34% P <0.001 Thrombosis Linearized rate: 0.11% per patient-year Linearized rate: 0.24% per patient-year P = 0.65 TE Linearized rate: 0.72% per patient- year Linearized rate: 0.87% per patient-year P = 0.59 Major Bleed Linearized rate: 0.61% per patient-year Linearized rate: 1.21% per patient-year P = 0.04 Structural Valve Failure N = 0 N = 0 - Low INR Cohort: patients managed at INR , in patients with preserved sinus rhythm and LV Function. **Standard Cohort: patients managed at INR Note the Medtronic Open Pivot Indications for Use: Adequate anticoagulant and/or antiplatelet therapy should be administered. Selection of an anticoagulant and/or antiplatelet regimen is based on the particular needs of the patient and the clinical situation. In this single-center study, 909 Medtronic Open Pivot valves were implanted in prospectively assigned cohorts and followed for an average of 10.2 ± 5.1 years totaling 10,123 patient-years. Cohort results were retrospectively propensity-matched resulting in an analysis of 3096 patient-years.
7 DESIGNED FOR EASY ACCESS Cardioblate irf Irrigate For Transmurality Create quick cardiac lesions that achieve reliable, reproducible conduction block with the Cardioblate Irrigated RF (irf) Surgical Ablation System. The Cardioblate irf portfolio puts surgeons in control with uniquely malleable devices designed for use in sternotomy or minimally invasive cardiac surgery procedures, as well as arrested or beating heart procedures. Bipolar irf devices offer the added benefits of real-time adaptive energy delivery and automated confirmation of transmurality. Product Ordering Information PRODUCT CATALOG CODE NO. USE Cardioblate BP2 Surgical Ablation Device each Single Cardioblate BP2/Pen Surgical Ablation System each Single Cardioblate LP Surgical Ablation Device each Single Cardioblate LP/Pen Surgical Ablation System each Single Cardioblate Surgical Ablation Pen each Single Cardioblate Surgical Ablation XL Pen each Single Cardioblate Generator each Reusable Commercially available pressure bag, tubing and normal saline also required. References 1. Medtronic Animal Study on File RSCH0077: Medtronic Cardioblate BP Surgical Ablation Device Chronic Ovine Model Summary. 2. Cardioblate Surgical Ablation System Technical Manual. A Rev. D. Medtronic, Inc AtriCure Ablation and Sensing Unit (ASU) User s Manual. Model ASU2-115, Model ASU P Rev. G. p Erdogan A, Grumbrecht S, Neumann T, Neuzner J, Pitschner H. Microwave, irrigated, pulsed, or conventional radio frequency energy source: which energy source for which catheter ablation? PACE 2003; 26:(Pt. II): Demazumder D, Mirotznik M, Schwartzman D. Biophysics of radiofrequency ablation using an irrigated electrode. Journal of Interventional Cardiac Electrophysiology (5): SHAPING SURGICAL ABLATION Unique malleability delivers irrigated (irf) to confidently create transmural lesions. Cardioblate Surgical Ablation Portfolio LP and BP2 (Bipolar Clamp) Indications for Use: is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Contraindications: The Cardioblate LP and BP2 Surgical Ablation Device should not be used for: n Patients that have active endocarditis at the time of surgery. n Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown. Pen/XL Pen Indications for Use: is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Contraindications: The Cardioblate Surgical Ablation Pen should not be used for patients that have active endocarditis at the time of surgery. MAPS Indications for Use: The Cardioblate MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker. Contraindications: The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device should not be used for patients that have active endocarditis at the time of surgery. Cardioblate irf Generator The Cardioblate Surgical Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. To avoid the risk of electrical shock and/or burns to the patient, do not touch the patient while touching the outer housing or connections on the Cardioblate generator. Do not allow the patient to come into contact with the grounded metal surfaces during RF energy delivery. Potential Complications: Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are: tissue perforation, extension of extracorporeal bypass, perioperative heart rhythm disturbances (atrial and/or ventricular), postoperative embolic complications, pericardial effusion or tamponade, injury to the great vessels, valve leaflet damage, conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation. Refer to Instructions for Use which accompany each product. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product. Cardioblate is a registered trademark of Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Toll- Free: (800) LifeLine CardioVascular Technical Support Tel: (877) Tel: (763) Fax: (763) rs.cstechsupport@medtronic.com Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. Cardioblate irf Surgical Ablation System medtronic.com UC EN 06/2016 Malleable Jaws Shape the malleable 7 cm electrodes as the anatomy requires. SHAPE AND ABLATE Cardioblate Surgical Ablation Systems have been designed with maneuverability, placement and visualization in mind Uniquely malleable devices put surgeons in control of every procedure with superior energy sources that give greater confidence of lesion transmurality. Malleable Neck Enhances maneuverability, placement and visualization Cardioblate BP2 Irrigated RF Bipolar Clamp Low Profile Precurved, rigid jaws ease placement in smaller anatomies Rotatable Jaws DELIVER irf ENERGY Real-time feedback, real-time power Delivering precise, irrigated RF energy based on tissue requirements is key to achieving transmurality and consistent conduction block. The Cardioblate Generator customizes energy delivery based on tissue requirements to provide reliable, reproducible transmurality. Connects to Cardioblate irf Clamps or Pens. Bipolar algorithm confirms transmurality 1 Consistent power even with high impedance Auto and manual power settings Built-in safety features RF From a More Capable Generator Cardioblate Generator irf vs. Dry RF Irrigated RF Energy Produces Deeper Lesions 4,5 Irrigated RF Irrigation (facilitates energy flow) REACH CHALLENGING AREAS Added versatility to reach all areas of the heart Cardioblate irf Surgical Ablation Pens facilitate cardiac ablation in areas that are difficult to ablate with a bipolar clamp. Oscillating the pen over the tissue, without applying pressure, transfers irrigated RF energy. A low impedance path allows energy to be driven further into the tissue for a deeper lesion. 5 The Cardioblate XL Surgical Ablation Pen features an extended length monopolar shaft (20 cm) designed for cardiac ablation procedures on difficult-to-access tissue. It is especially useful for: Small thoracotomy approaches Larger or barrel-chested full sternotomy patients Versatile Approach Shape the device to create any lesion Comfortable Fit Ergonomic handheld design Cardioblate Surgical Ablation Pens Consistent Power in the Presence of Higher Impedance Ergonomic Handle Clearer line of sight enhances maneuverability, placement and visualization Medtronic irf 2 vs. Competitor Dry RF 3 Medtronic Competitor Dry RF Microbubbles (barrier to energy flow) One-of-a-kind malleable jaws conform to unique cardiac anatomies. Cardioblate BP2 and LP irrigated RF clamps are great choices for surgical ablation procedures performed via sternotomy and offer: Ability to ablate on an arrested or beating heart Irrigated electrodes for efficient energy delivery Rotate the head up to 300 degrees to facilitate placement in any anatomy Power (Watts) W 50 W 25 W Competitor Load Impedance (Ohms)
8 Medtronic Open Pivot Heart Valve - Important Labeling Information for United States Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Medtronic Open Pivot Heart Valve - Important Labeling Information for Geographies Outside of the United States Indications: The Medtronic Open Pivot Heart Valve is intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning heart valves. This device may also be used to replace a previously implanted prosthetic heart valve. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Warning: Persons allergic to cobalt, chromium, or nickel may suffer an allergic reaction to this device. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Medtronic Open Pivot Aortic Valved Graft (AVG) - Important Labeling Information for United States Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Potential Adverse Events: Certain complications may occur with heart valve procedures. Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions for Use packaged with each valve for a complete listing of warnings and precautions. Medtronic Open Pivot Aortic Valved Graft (AVG) - Important Labeling Information for Geographies Outside the United States Indications: The Medtronic Open Pivot Aortic Valved Graft (AVG) is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is required. This device may be used to replace a previously implanted prosthetic heart valve and conduit. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy or who exhibit a sensitivity to polyester or materials of bovine origin. Warning: Do not implant this device in patients who exhibit a sensitivity to polyester or materials of bovine origin. Potential Adverse Events: Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Caution: Refer to the Instructions for Use packaged with each valve for a complete listing of warnings and precautions. References 1. Kelly S, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. In J Artif Organs, 1999; 22: Emery R, et al. The initial United States experience with ATS mechanical cardiac valve prosthesis. The Heart Surgery Forum, 2001; 4(4): Sezai A, Hata M, Niino T, et al. Fifteen years of experience with ATS mechanical heart valve prosthesis. J Cardiothorac Surg (4): Note: Compared to SJM valve, St. Jude Medical, Inc. 4. Van Nooten GJ, Caes F, Fancois K, et al. Fifteen years single-center experience with the ATS bileaflet valve. J Heart Valve Dis (4): Emery RW, Van Nooten GJ, Tesar PJ, et al. The initial experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Surg (2): Westaby S, Van Nooten G, Sharif H, et al. Valve replacement with the ATS open pivot bileaflet prosthesis. Eur J Cardiothorac Surg (8): Dumont K, Vierendeels J, Kaminsky Rand, et al. Comparison of the hemodynamic and thrombogenic performance of two bileaflet mechanical heart valves using a CFD/FSI model. J Biomech Eng (4): Shiono M, Sezai Y, Sezai A, et al. Multi-institutional experience of the ATS open pivot bileaflet valve in Japan. Ann Thorac Cardiovasc Surg (1): Krian A. Clinical results of a large series of ATS valve implants. In: Krian A, Matloff JM, Nicoloff DM, eds. Advancing the technology of bileaflet mechanical heart valves: Springer Verlag; 1998: Feng Z, et al. In vitro hydrodynamic characteristics among three bileaflet valves in the mitral position. Artif Organs. 2000;24(5): Nakamura Y, Nakano K, Tagusari O, et al. An alternative option for elderly patients with a small aortic annulus: the 16 mm ATS valve. J Heart Valve Dis (6): Kobayashi Y, Fukushima Y, Hayase T, et al. Clinical outcome of aortic valve replacement with 16-mm ATS-advanced performance valve for small aortic annulus Ann Thorac Surg (4): Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patients quality of life. Ann Thorac Surg (2): Umeda T. An evaluation study on the quietness of the ATS valve. Ann Thorac Cardiovasc Surg (3): A B A B A B A B A B A B UNIQUE LEAFLET ACTION A REMARKABLY QUIET VALVE In two one-year postoperative studies, only 18.8% of Medtronic Open Pivot valve patients were aware of their valve sound, compared to 78% of cavity pivot valve patients. 13,14 Medtronic Open Pivot AP Supra-annular valve with compact cuff configuration for excellent suturability and conformability. Medtronic Open Pivot Heart Valves Product Specifications Standard Intra-annular Medtronic Open Pivot Standard Heart Valve AORTIC MITRAL Tissue Geometric Tissue Geometric Valve Standard Orifice Inner Valve Standard Orifice Inner Annulus Orifice Annulus Orifice size Model Diameter (A) size Model Diameter (A) Diameter (B) Area Diameter (B) Area Number Number (cm 2 ) (cm 2 ) FA DM19 * DM21 * FA DM23 * FA DM FA DM FA DM FA DM FA31 * DM Medtronic Open Pivot AP and AP360 Heart Valves AORTIC MITRAL STANDARD AORTIC STANDARD MITRAL AP AORTIC PERFORMANCE IN DESIGN Medtronic Open Pivot Standard Intra-annular valve with generous, compliant cuff for exceptional implantability. AP/AP360 Supra-annular Tissue Geometric Valve AP/AP360 Orifice Inner Annulus Orifice size Model Diameter (A) Diameter (B) Area Numbers (cm 2 ) DA DA DA DA DA DA DA DA DA DA DA DA26 Tissue Geometric Valve AP/AP360 Orifice Inner Annulus Orifice size Model Diameter (A) Diameter (B) Area Numbers (cm 2 ) DM16 * DM16 * DM18 * DM18 * DM20 * DM20 * DM DM DM DM DM DM26 AP360 AORTIC AP MITRAL DA DA28 * DM DM28 Medtronic Open Pivot Accessories Medtronic Open Pivot AVG AP360 MITRAL Model Number Descriptor Intra-annular, Aortic Valved Graft Medtronic Open Pivot AP360 Supra-annular valve with flanged cuff configuration for improved flexibility, needle penetration and conformability. Medtronic Open Pivot Intra-annular Aortic Valved Graft (AVG) 576 Open Pivot Sizer Set 556 Aortic and Mitral Rotators 557 Mitral Hex-End Rotator and Holder Set 569 Bendable Handle 581 Mitral Screw-On Rotator Set * Model not currently available for sale in the United States. Valve size Model Numbers AG AG AG AG27 Medtronic Open Pivot Mechanical Heart Valves AG AG31 * AG33 * 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Toll- Free: (800) medtronic.com LifeLine CardioVascular Technical Support Tel: (877) Tel: (763) Fax: (763) rs.cstechsupport@medtronic.com 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. UC EN 05/2016 THE DESIGN DIFFERENCE With the Medtronic Open Pivot valve, there are no orifice recesses or cavities unlike other bileaflet valves where potential thrombus may form. 1,2 Cavity pivot valves have an area where statis could occur. Open Pivot Cavity Pivot UNIQUE AXIS OF SUSPENSION IN LEAFLET DESIGN The Open Pivot valve is designed so that a greater portion of the leaflet is distal to the axis of suspension, allowing leaflets to respond to the patient s blood flow. The result is exceptionally efficient leaflet movement responsive to physiological demands and excellent hydrodynamic performance. 10 Unimpeded Blood Flow 3,4 With no cavities for blood to slow or pool, the valve design minimizes flow disruption and turbulence in the pivot area during both forward and retrograde flow. 1,5-7 Open Pivot Cavity Pivot OPEN PIVOT DESIGN LEADS TO EXCELLENT HEMODYNAMICS AND REDUCED HEMOLYSIS By design, continuous washing of the pivot in both open and closed positions provides gentle treatment of red blood cells and reduced hemolysis. 8,9 Axis of Suspension Open Pivot Axis of Suspension Cavity Pivot SINGLE-PLANE ORIFICE DESIGN FOR IMPLANTABILITY n Allows for improved valve seating and implant regardless of suture technique n Minimal sub-annular exposure reduces orifice ring stress 11,12 n Made of solid pyrolytic carbon with a strengthening band of thin titanium that provides large orifice-to-annulus ratios while retaining structural integrity Leaflets rest on the hinge. Leaflets rest in hinge cavities and require vigorous mechanical sweeping and high-velocity flushing.
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11 Band Promotional Posters CHUCK S GARAGE PRESENTS CHUCK S G ARA GE PRESEN T S UNDER GROUND JAMM BAND FULL REVERSE AMERY COURT INVER GROVE HEIGHTS, MN AMERY COURT INVER GROVE HEIGHTS, MN PM BYOB WATER, POP & FOOD PROVIDED PM BYOB WATER, POP & FOOD PROVIDED
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