Tailored reliability for patients and surgeons The voice of experience “We observed that the Carbomedics mechanical prosthesis had excellent durability with no structural failures, good hemodynamics, and a low incidence of TE.” * 1 “Our experience demonstrates excellent functional result of the Carbomedics valve in both mitral and aortic positions. Valve-related events were low and often caused by patient-related factors as opposed to the presence of the prosthesis.” * 1 “In our experience, structural valve failure with this device is inexistent. The Carbomedics mechanical valve is a solid choice for long-term valvular replacement.” * 1 Sorin Group Italia Srl A wholly-owned subsidiary of LivaNova PLC Via Crescentino - 13040 Saluggia (VC) Italy Теl: +39 0161 487472 - Fax: +39 0161 487316 [email protected] 1. Bouchard et al., Twenty-Year Experience With the CarboMedics Mechanical Valve Prosthesis. - Ann Thorac Surg 2014;97:816–23. Federal law (USA) restricts this device to sale by or on the order of a physician. Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects. © 2020 LivaNova all rights reserved. * LivaNova post-market surveillance classifies the risk of structural valve failure and thromboembolic events P as improbable (10-6 < P ≤ 10-5). Bileaflet mechan

Tailored options for desirable patient outcomes1 Tailored performance for excellent clinical outcomes With its Carbomedics line of products LivaNova offers cardiac surgeons and patients a complete set of mechanical heart valve solutions to reliably treat even the challenging cases. Tailored ease of implant Tailored solutions for patients and surgeons The Carbomedics name is intrinsically linked to the historical development of mechanical heart valves. Based on the expertise and with the clear mission of providing highly reliable and technologically advanced solutions, in 1986 Carbomedics introduced...

Tailored performance for desirable clinical outcomes Tailored ease of implant Tailored solutions for patients and surgeons 1. Bouchard et al., Twenty-Year Experience With the CarboMedics Mechanical Valve Prosthesis. Ann Thorac Surg 2014;97:816–23.

Tailored safety and durability Historically focused on biocompatible materials Thanks to its robust design, the Carbomedics bileaflet mechanical heart valve has extremely low incidence of post-operative structural failures* in over 1 million implants worldwide. Carbomedics Pyrolite® Carbon is engineered to provide excellent thromboresistance* and mechanical resistance.1 This is achieved by co-depositing a small amount of Silicon during the manufacturing process, because the Silicon acts as a reinforcing element to the crystal structure of Pyrolytic Carbon.1 The surface is then polished to remove...

A robust design* to minimize post-operative structural failures Pyrolytic carbon coated leaflets The leaflets of the Carbomedics valves are made of a substrate of tungsten filled graphite coated with Pyrolite® Carbon. The presence of Tungsten provides better radiopacity allowing a non invasive diagnostic observation of the leaflets' motion through fluoroscopy or similar methodologies. Pyrolytic carbon housing Differently from other substrate processes, which results in a graphite core coated with pyrolytic carbon, Carbomedics valves employ an advanced mandrel process resulting in a low profile...

Tailored performance for desirable clinical outcomes1,2 1. Bouchard et al., Twenty-Year Experience With the CarboMedics Mechanical Valve Prosthesis. Ann Thorac Surg 2014;97:816–23. 2. Nishida et al., Single-institution, 22-year follow-up of 786 CarboMedics mechanical valves used for both primary surgery and reoperation. J Thorac Cardiovasc Surg 2014;147:1493-8).

Carbomedics valves are engineered to achieve proven clinical benefits for patients throughout their lifetime1,2 In its long clinical history, Carbomedics valves have demonstrated great levels of safety and reliability, with a considerably low incidence of complications and post-operative structural failures.1,3 The enhanced orifice hinge design allows for low thrombogenicity, minimizing pannus overgrowth. The inner surfaces of the pivots are completely open to the flow for washing when the leaflets are closed.4 The effectiveness of the Carbomedics design is reflected in the very low linearized...

Freedom from valve-related mortality after mitral and aortic valve replacement*.1,2 100 80 * All sudden or unknown causes of death were considered valve related in accordance to the Guidelines for reporting morbidity and mortality after cardiac valvular operations. Proven reliability with very low thrombogenicity 3 Thrombogenicity remains to date one of the major concerns related to the implantation of mechanical heart valves. The safety of the Carbomedics valve with respect to thrombogenicity has been extensively proved in published scientific literature* and is well recognized by the current...

A unique platform with favorable hemodynamics.1,2 One of the key factors influencing the clinical success of a mechanical heart valve prosthesis is its hemodynamic efficiency. The opening angle and travel arc of the Carbomedics valves' leaflets are determined by hydrodynamic testing in order to achieve low pressure gradients and an optimal balance between forward flow and regurgitant volume, thus minimizing total energy loss while promoting quiet functioning.3 Top Hat, top hemodynamic performance.1,4 To further optimize hemodynamics, especially in small aortic annuli, LivaNova features in its...

Effective Orifice Area (cm²) 0 21 Patient Annulus Diameter (mm) CPHV Intra-annular *In vitro test - 5l/min 70 bpm (Data on file at Livanova) Mean Pressure Gradients (mmHg) Tissue Annulus Diameter Carbomedics hemodynamics at rest and under stress3 Carbomedics has shown good performance even under stress.3 “ The result is an optimization of the discharge coefficient with exercise, indicating a good design of the moving part of the valve” . Mean Pressure Difference (mmHg) In a published experience on small annuli (sizes 19 and 21), Under stress 1. LivaNova data on file. 2. Bernal et al., The Carbomedics...