4
The Sovereign solution to annuloplasty rings SOVERING TM Carbofilm TM coated annuloplasty rings
The Sovereign solution to annuloplasty rings
SOVERING TM
CarbofilmTM coated annuloplasty rings
2
Sovering annuloplasty rings are flexible devices made of:
• Radiopaque silicone core.
• Knitted polyester (PET) fabric, coated with CarbofilmTM.
• Carbofilm TM coating enhances biocompatibility and hemocompatibility and minimizes the fibrous overgrowth.(1-8)
• One piece construction (silicone/PET fabric) avoids displacement between the silicone core and the outer fabric when suturing, ensuring compactness.
• The flexibility of the core helps to restore the orifice area, while allowing the natural 3D motion
of the annulus during the cardiac cycle. Flexibility reduces the stress on the sutures,
minimizing the likelihood of dehiscence.
• Silicone core impregnated with Barium sulfate enables radiographic visualisation.
• White markers facilitate commissural alignment and device seating.
SOVERING TM
Benefits:enhanced bio-hemocompatibility and
compactness
SOVERINGTRICUSPID BANDTM
SOVERINGMITRAL BANDTM
SOVERINGMITRAL RINGTM
3
SOVERING TM
MODELS
LivaNova provides surgeons with two mitralmodels and one tricuspid model.
• SOVERING MITRAL RING and SOVERING MITRAL BAND
• SOVERING TRICUSPID BAND
A wide range of solutions
• Rings/Bands are pre-mounted on a holder composed of
two parts. The clutch, designed for a safe connection
with the UNI Handle, is sutured to a template which
mimics the shape of the mitral and tricuspid annuli.
Surgeons may choose:
• To remove the holder (clutch+template) after suturing.
• To remove first the clutch maintaining the template in place
for proper suturing without distortion then the template.
• Ring/Band selection is based on the measurement of
theintercommissural distance and matching of the same
to the notches on the sizer. Ring/Band selection may also
be based on the measurement of the anterior leaflet area with
the same sizer.
Easy implantability
SURGICAL CONSIDERATIONS
Practical and safe
PACKAGING
Each MITRAL and TRICUSPID SOVERINGannuloplasty system box contains:
• One ring (or band), pre-mounted on a holder.
clutch
template
02/1
6 IC
0870
0011
63/E
© 2016 LivaNova all rights reserved.Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects.
CatalogNumber Name Description
The procedures described in this publication are provided for the convenience of the implanting medical professional, and for purposes of illustration only. Accordingly, the procedures are not intended to be exhaustive and may not be the only procedures available at the time of implantation for performing bioprosthesis procedures. Sorin Group Italia S.r.l. therefore makes no representations as to the safety or effectiveness of the procedures. Sorin Group Italia S.r.l. relies on the medical professional to use his or her medical judgement and experience and know-how in implantation techniques for a particular patient. Detailed descriptions of indications, contra-indications, precautions and potential side effects are to this end provided in the product’s Instructions for Use manual.
1. Aebischer P, Sasken H, Galletti PM. “Effect of an ultra low temperature isotropic carbon coating on intraperitoneally implanted polyethylene tubes.” 12th Annual meeting of the Society of Biomaterial, St Paul, Usa, June 1986.2. Aebischer P, Goddard M, Sasken H, Hunter TJ, Galletti PM. “Tissue reaction to fabrics coated with turbostratic carbon: subcutaneous versus vascular implants.” Biomaterials 1988;9: 80-85.3. Rizzo E, Fiori R, Galloni M, Pascale S, Pasquino E, Cannas M. “In vitro and systemic effects of Carbofilm coated silicon elastomers.” Materials in Clinical Application, Vincenzini Eds, Techna Srl, 1995; 393-401.4. Noera G, Fattori G, Incerti Medici A, Monari E, Lodi R, Gatti AM, Galloni M, Pasquino E, Vallana F. “Small diameter vascular graft evaluation by replacement of sheep carotid artery: short term results with carbon coated prostheses.” La Chir Torac 1989; 42:401-405.5. Cenni E, Arciola CR, Ciapetti G, Granchi D, Savarino L, Stea S, Cavedagna D, Curti T, FalsoneG, Pizzoferrato A. “Platelet and coagulation factor variations induced in vitro by polyethylene terephthalate (Dacron) coated with pyrolytic carbon.” Biomaterials 1995; 16: 973-976.6. Cenni E, Granchi D, Ciapetti G, Stea S, Verri E, Gamberini S, Gori A, PizzoferratoA. “In vitro complement activation after contact with pyrolytic carboncoated and uncoated polyethylene terephthalate.” Journal in material science: materials in medicine 1997; 8: 771-774.7. Bernex F, Mazzucotelli J, Benhalem-Sigaux N, Leandri J, Loisance D. “Endhotelialization improvement of Dacron surfaces y carbon coating.” ASAIO, 1992.8. Virmani R, Santarelli A, Galloni M, Pasquino E, Bartorelli A. “Tissue response and biocompatibilty of the Sorin CarbostentTM experimental results in porcine coronary arteries.” X th TCT Washington, 7-10 October, 1998.
References* Nominal dimensions
SOVERING TRICUSPID BANDTM
SB28TSB30TSB32TSB34TSB36T
ICV0834ICV0835ICV0836ICV0837ICV0838
2830323436
6468727680
33.835.837.839.841.8
27.829.831.833.835.8
OrderingNumberRef Size Lenght*
(mm)External*
diameter A(mm)
Internal*diameter B
(mm)
ICV0826ICV0827ICV0828ICV0829ICV0830ICV0831ICV0832ICV0833
SB26MSB28MSB30MSB32MSB34MSB36MSB38MSB40M
2628303234363840
6064687276808488
31.233.235.237.239.241.243.245.2
25.227.229.231.233.235.237.239.2
SOVERING MITRAL BANDTM
SOVERING MITRAL RINGTM
ICV0839ICV0840ICV0841ICV0842ICV0843ICV0844ICV0845ICV0846
SA26MSA28MSA30MSA32MSA34MSA36MSA38MSA40M
2628303234363840
--------
31.233.235.237.239.241.243.245.2
25.227.229.231.233.235.237.239.2
Product ordering information Accessories ordering information
ICV0664 UNI HandleBendable handle for
RINGS, BANDand SIZERS
ICV0824 Sizer setSizer set for
SOVERING MITRAL RING andSOVERING MITRAL BAND
ICV0825 Sizer setSizer set for
SOVERING TRICUSPID BAND
(not provided sterile)
Manufactured by:Sorin Group Italia SrlA wholly-owned subsidiary of LivaNova PLCVia Crescentino - 13040 Saluggia (VC) ItalyТеl: +39 0161 487472 - Fax: +39 0161 [email protected]
