Carbomedics AnnuloFlex TM
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Product ordering information Carbomedics AnnuloFlex Carbomedics AnnuloFlo RING SPECIFICATIONS A Size (mm) 1 Nominal Ring Inner Dimension (mm) B Carbomedics AnnuloFlex Carbomedics AnnuloFlex and Carbomedics AnnuloFlo Ring are MRI Compatible Mitral & tricuspid flexible annuloplasty ring/band Accessories ordering information (not provided sterile) INSTRUMENTS A Catalog Number Sizer Set (which includes): - One sizer, size 26/28 - One sizer, size 30/32 - One sizer, size 34/36 Holder handle Carbomedics Universal Handle One set of instruments accomodate both Carbomedics AnnuloFlex and Carbomedics AnnuloFlo System Empty tray System includes complete sizers set to facilitate surgical procedures and achieve optimal clinical results.1,3 Malleable, notched sizers for mitral and tricuspid use Malleable, detachable implant handle Dedicated instrument case Carbomedics AnnuloFlo Mitral rigid annuloplasty ring A Ring/Sizer Specifications and Instruments are identical for both Carbomedics AnnuloFlo and Carbomedics AnnuloFlex systems. B Represents transverse diameter at points 1mm inside inner diameter (inside one third) on both sides of ring. C Mitral and tricuspid indications. D Mitral indication only. Khsettry et al., Prospective Study of Mitral Valve Repair with the CarboMedics AnnuloFlex™ Annuloplasty System: Effectiveness and Safety after One Year. The Journal of Heart Valve Disease 2005;14:105-113 Pragliola et al., "Long-term results of an open flexible prosthetic band for mitral insufficiency". Asian Cardiovascular & Thoracic Annals 2014, Vol. 22(7) 811–815 Khsettry et al., Current Trends in Mitral Valve Repair Techniques in North America. The Journal of Heart Valve Disease 2012;21:690-695 Della Barbera et al., "Sovering annuloplasty rings: Experimental pathology in the sheep model." Cardiovascular Pathology 14 (2005) 96–103 INDICATIONS: The Carbomedics Annuloplasty Rings are indicated as reinforcement for repair of the human cardiac mitral valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The Carbomedics AnnuloFlex Annuloplasty Rings are also indicated as reinforcement for repair of the human cardiac tricuspid valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty rings should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement. MRI conditional. For professional use. Please contact us through our website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Consult your labeling. Manufactured by: 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 info.cardiacsurgery@livanova.com © 2020 LivaNova all rights reserved. TOP POTENTIAL SIDE EFFECTS: Adverse events potentially associated with the use of mechanical prosthetic annuloplasty rings include: Death; failure or degeneration of the patient’s natural valvular apparatus due to progression of disease, endocarditis, or inadequate/incomplete repair of the valvular and subvalvular structures; Reoperation and explant; Suture obliteration of the circumflex coronary artery; Residual or recurrent regurgitation; complications related to prolonged bypass, aortic cross-clamping, and inadequate myocardial protection; stenosis; partial dislodgment of the ring from its site of attachment; thromboembolism; malfunction of the ring due to distortion at implant or physical or chemical deterioration of ring components; hemolysis; tearing of the cloth covering with the use of cutting needles or serrated forceps; A-V block; bleeding diatheses related to the use of anticoagulant therapy; low cardiac output; systolic anterior motion and left ventricular outflow tract obstruction whenever a large anterior and/or posterior leaflet is present; right heart failure; prosthesis thrombosis; infection. CONTRAINDICATIONS: The annuloplasty devices are contraindicated for the following: • severe organic lesions with retracted chordæ; • congenital malformations with lack of valvular tissue; • evolving bacterial endocarditis; • extensive calcification, which upon removal, does not result in pliable leaflets. Annuloplasty Ring Systems, making imp

CARBOMEDICS AnnuloFlexTM commissure reference guides posterior midline guide anterior midline guide CARBOMEDICS AnnuloFloTM suture spacing guides Complete or partial annuloplasty of the mitral and tricuspid valves. commissure reference guides posterior midline guide The flexible design of the Carbomedics AnnuloFlex Annuloplasty System provides implant versatility to accommodate surgeon preference and various clinical indications.1,3 • Reduces hospital inventory. • Full flexibility delivers three-dimensional compliance that Enhanced visibility through • Translucent low profile holder •...

Product ordering information Carbomedics AnnuloFlex Carbomedics AnnuloFlo RING SPECIFICATIONS A Size (mm) 1 Nominal Ring Inner Dimension (mm) B Carbomedics AnnuloFlex Carbomedics AnnuloFlex and Carbomedics AnnuloFlo Ring are MRI Compatible Mitral & tricuspid flexible annuloplasty ring/band Accessories ordering information (not provided sterile) INSTRUMENTS A Catalog Number Sizer Set (which includes): - One sizer, size 26/28 - One sizer, size 30/32 - One sizer, size 34/36 Holder handle Carbomedics Universal Handle One set of instruments accomodate both Carbomedics AnnuloFlex and Carbomedics...