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SURGICAL HEART VALVES

MITRAL VALVE REPAIR SOLUTIONS

Abbott’s customizable mitral valve repair products are suitable for implant using open sternotomy and minimally invasive approaches such as robotic surgery.

THE TAILOR FLEXIBLE ANNULOPLASTY RING AND BAND ARE FLEXIBLE AND ADAPTABLE TO SUSTAIN PHYSIOLOGIC MOVEMENT

The Tailor Flexible Annuloplasty Ring and Band are designed to maintain the size of a repaired mitral or tricuspid annulus while sustaining physiologic movement.

The Tailor Ring provides a customizable design

  • Anterior and posterior support allows dynamic annular motion during the cardiac cycle
  • Full, flexible ring can be tailored to address specific patient need

Tailor Band offers a simple alternative for tricuspid valve repair

  • Standard pre-cut C-band provides time-saving simplicity
  • Posterior support allows dynamic annular motion
  • Band provides an alternative for tricuspid valve repair
     
Tailor Flexible Annuloplasty Ring and Band to maintain the size of a repaired mitral or tricuspid annulus

THE ATTUNE RING HAS FLEXIBILITY WITH FINE-TUNING TO FIT INDIVIDUAL PATIENT ANATOMY

The symmetrical and asymmetrical adjustability of the Attune™ Ring allows the size and shape to be fine-tuned.

  • The ability to make small adjustments to the ring after placement is designed to help eliminate residual mitral regurgitation
  • Independent adjustability allows the annuloplasty to be localized to one side

The Abbott Attune Ring is designed to accommodate procedural needs

  • Suitable for implant using open sternotomy, minimally invasive, and robotic approaches
  • Available in 6 sizes, starting at 25 mm and increasing in 2 mm increments to 43 mm
Abbott Attune Ring implant to help eliminate mitral regurgitation

THE SÉGUIN SEMI-RIGID RING HAS A UNIQUE COMBINATION OF RIGIDITY AND FLEXIBILITY

The Séguin Semi-Rigid Ring provides surgeons a combination of rigidity and flexibility for mitral valve repair.

  • Semi-rigid, tri-dimensional posterior designed to preserve the physiologic motion of the annulus
  • More rigid anterior allows for annular remodeling
  • Solid one-piece core resists needle penetration and reduces potential for suturing through the core

Flexibility in just one step

The design advantages of the Séguin Semi-Rigid Ring delivery system employ a one-step process designed to save time and reduce complexity during surgery.

Abbott Seguin Semi-Rigid Ring for mitral valve repair

THE RIGID SADDLE RING HAS A NATURAL SADDLE-SHAPED DESIGN FOR DURABLE, COMPLETE REMODELING

  • Annular-height-to-commissural-width ratio of 15% mimics a healthy mitral annulus1
  • Titanium alloy core maintains anatomical shape and provides annular remodeling
  • Saddle shape contributes to efficient distribution of leaflet stress and chordal tension1-3
  • Redistribution of leaflet stress and chordal tension through saddle-shape remodeling may increase repair durability1,3,4

Ease of implantation

  • Polyester double-velour cuff is supported by a unique triangular core for a larger suture target
  • Clear, well-marked holder is designed to increase visibility during implant
  • Secure ergonomic handle quickly attaches and detaches to save time during implant
Abbott Rigid Saddle Ring mimics a healthy mitral annulus

MAT-2115462 v1.0 | Item approved for U.S. use only.

References
  1. Salgo IS, Gorman JH 3rd, Gorman RC, et al. Effect of annular shape on leaflet curvature in reducing mitral leaflet stress. Circulation. 2002;106(6):711-717.
  2. Jimenez JH, Soerensen DD, He Z, et al. Effects of a saddle shaped annulus on mitral valve function and chordal force distribution: an in vitro study. Ann Biomed Eng. 2003;31(10):1171-1181.
  3. Jimenez JH, Liou SW, Padala M, et al. A saddle-shaped annulus reduces systolic strain on the central region of the mitral valve anterior leaflet. J Thorac Cardiovasc Surg. 2007;134(6):1562-1568.
  4. Gorman JH 3rd, Jackson BM, Enomoto Y, et al. The effect of regional ischemia on mitral valve annular saddle shape. Ann Thorac Surg. 2004;77(2):544-548.
Important Safety Information
  • TAILOR RING/BAND
  • ATTUNE™ RING
  • SÉGUIN RING
  • RIGID SADDLE RING

  • SJM TAILOR™ ANNULOPLASTY RING OR
    SJM TAILOR™ ANNULOPLASTY BAND

    INDICATIONS

    The ring/band is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the ring/band.

    CONTRAINDICATIONS

    Use of the ring/band is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring/band is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the ring/band is contraindicated for active bacterial endocarditis.

    PRECAUTIONS

    • Sizers and accessories are supplied non-sterile, and must be cleaned and sterilized prior to each use.
    • Do not use cracked, crazed, deformed, or damaged sizer set components.
    • Do not bend sizers beyond a 90° angle.
    • Prior to using the sizers in the SJM Tailor™ & Attune™ ring robotic sizer set model TAR-510R, secure a suture to the sizer using the safety suture hole (see Figure 2). The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
    • Do not use a ring/band if the “USE BY” date on the packaging has passed.
    • The contents of the tray in which the ring/band is supplied have been sterilized. Ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring/ band during removal of the identification tag and suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
    • After selecting the appropriate size ring, should the surgeon elect to convert the ring to a C-band, the ring must be cut within the designated cut area. The cut area is identified by the two notched windows on the ring holder just inside the trigone indicator tabs. Once the ring has been cut, remove the cut segment prior to implantation of the ring.
    • After the ring has been cut and the cut segment removed, care should be taken to remove any loose suture within the cut area prior to implantation of the ring.
    • To avoid damage to the fabric covering the ring/ band, cutting edge needles should not be used, and manipulation with forceps should be avoided during implantation.
    • If an implant suture inadvertently pierces a ring/ band retaining loop, the holder may not release from the ring/band. To facilitate release, cut the retaining loop suture close to the implant suture.
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be
    • considered for all patients undergoing dental or other potentially bacteremic procedures.
       

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring/band from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • ATTUNE™ FLEXIBLE ADJUSTABLE
    ANNULOPLASTY RING

    INDICATIONS

    The Attune™ Flexible Adjustable Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using an Attune™ Ring.

    CONTRAINDICATIONS

    Use of the Attune™ Flexible Adjustable Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement, and where there are congenital malformations which lack valvular tissue. Additionally, use of the Attune™ Ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the Attune™ Ring is contraindicated for active bacterial endocarditis.

    PRECAUTIONS

    • Do not use an Attune™ Flexible Adjustable
    • Annuloplasty Ring if the “USE BY” date on the packaging has passed.
    • Examine the device packaging carefully, and ensure the tray is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ Customer Service.
    • Sizers are supplied non-sterile and must be cleaned and sterilized prior to each use.
    • Do not used cracked, crazed, corroded, deformed, damaged, or degraded sizer set components.
    • Prior to using the sizers in the SJM Tailor™ & Attune™ Ring Robotic Sizer Set models TAR-510R or
    • TAR-505R, secure a suture to the sizer using the safety suture hole. The suture should be long enough to remain outside the patient at all times the sizer is inside the patient. In the event that the sizer is dropped inside the patient, the safety suture can be used to retrieve the sizer.
    • Remove the Attune™ Ring from the support prior to implantation.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the Attune™ Ring when removing the identification tag and suture.
    • Do not cut the Attune™ Ring.
    • To avoid damage to the Attune™ Ring, do not us cutting edge needles, and exercise care when holding or manipulating the Attune™ Ring with forceps.
    • Implantation of the Attune™ Ring has not been evaluated with the use of nitinol clips.
    • Do not place suture(s) through the posterior portion of the Attune™ Ring prior to finalizing and securing the adjustment, as this may result in disabling the adjustment suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system. Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental procedures.

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus; hemolysis; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the Attune™ Ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • SJM™ SÉGUIN ANNULOPLASTY RING / SJM™ SÉGUIN
    ANNULOPLASTY RING SIZER SET MODEL SAR-501

    INDICATIONS

    The SJM™ Séguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes. It is the responsibility of the surgeon to determine that the valve is repairable and does not require replacement. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the SJM™ Séguin Annuloplasty Ring. The SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 is indicated for use with the SJM™ Séguin Annuloplasty Ring.

    CONTRAINDICATIONS

    Use of the SJM™ Séguin Annuloplasty Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the SJM™ Séguin Annuloplasty Ring is contraindicated for active bacterial endocarditis. Use of the SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 with products other than the SJM™ Séguin Annuloplasty Ring is contraindicated. When sterilizing the SAR-501 sizer set, any sterilization method other than steam is contraindicated.

    PRECAUTIONS

    • SJM™ Séguin Annuloplasty Ring
    • Do not use the ring if the “USE BY” date on the packaging has passed.
    • Examine the device packaging carefully, and ensure the pouch is unopened and unbroken. If you note any damage, do not use the device, and contact St. Jude Medical™ customer service.
    • Remove the identification tag and suture prior to implantation. Avoid cutting or tearing the ring during removal of the identification tag and suture.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Do not place sutures in the atrial tissue, as this may result in impairment of the cardiac conduction system.
    • Do not attempt to deform or otherwise alter the configuration of the prosthetic ring to conform to a specific annular anatomy, as this could damage the ring. If the ring is not suitably sized for the annulus, a larger or smaller ring should be chosen.
    • To avoid damage to the fabric covering the ring, do not use cutting edge needles, and avoid manipulation with forceps during implantation.
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.
    • SJM™ Séguin Annuloplasty Ring Sizer Set
    • Model SAR-501
    • All sizer set components are supplied non-sterile, and must be cleaned and steam sterilized prior to each use.
    • The sterilization temperature must not exceed 138°C (280°F).
    • The autoclavable tray and cover do not provide a sterile barrier.
    • Do not use cracked, deformed, or damaged sizer set components.
    • Do not bend handles beyond a 90° angle.
    • Do not expose sizer set components to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

    POTENTIAL ADVERSE EVENTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating re-operation may occur at varying intervals and include: thrombus; hemolysis; ring fracture; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

  • SJM™ RIGID SADDLE RING
    INDICATION FOR USE

    The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilation of the mitral valve annulus caused by disease states such as degenerative disease, rheumatic disease, ischemia, or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no subvalvular lesions and normal valvular movements, prosthetic ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

    CONTRAINDICATIONS

    Use of the SJM™ Rigid Saddle Ring is contraindicated in cases where severe organic lesions with retracted chordae tendineae require valvular replacement and where there are congenital malformations which lack valvular tissue. Additionally, use of the ring is contraindicated whenever the physician determines that the remaining functional valve tissue and valve support structures are not adequate to provide the required hemodynamic performance or structural strength. Use of the SJM Rigid Saddle Ring is contraindicated for active bacterial endocarditis.

    SUMMARY OF PRECAUTIONS

    • Do not use a ring if the “USE BEFORE” date on the packaging has passed.
    • The contents of the tray in which the ring is supplied have been sterilized. Ensure the tray
    • and the seal are unopened and unbroken.
    • Remove the serial number tag and suture prior to implantation. Exercise care to avoid cutting or tearing the ring during removal of the identification tag.
    • Do not place sutures in the circumflex coronary artery or in the right coronary artery.
    • Sutures should not be placed in any atrial tissue, as impairment of cardiac conduction may occur.
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked or deformed sizers.
    • To avoid damage to the fabric covering the ring, cutting edge needles should not be used and manipulation with sharp-toothed metal forceps should be avoided during implantation.
    • If an implant suture inadvertently pierces a ring retaining loop, the holder may not release from the ring. To facilitate release, cut the retaining loop suture close to the implant suture.
    • Take care to remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
    • Do not alter or deform ring to conform to the anatomy.
    • Prophylactic antibiotic treatment should be considered for all patients undergoing dental or other potentially bacteremic procedures.

    SURGICAL CONSIDERATIONS

    • Suture techniques may vary according to the preferences of the implanting surgeon and the needs of the patient. Please consult the references listed in this manual for further informatio regarding surgical options for mitral valve repair. 1,2,3
    • To avoid distortion of the patient’s annulus, it is important to maintain even suture spacing within the annular tissue.
    • It is imperative to retain correct positioning of the leaflets relative to the SJM Rigid Saddle Ring. The SJM Rigid Saddle Ring commissure markers and posterior marker should be used as reference points for reconstruction of the annulus.
    • To securely anchor the sutures in the sewing cuff, place the sutures slightly outside of the running green suture marker. Sutures anchoring the ring must be placed so as to engage the fibrous tissue that connects the base of the leaflet, the atrium, and the orifice of the ventricle.
    • To ensure adequate distribution of suture stresses in patients with cardiomyopathy, numeroussutures should be used to secure the ring.1
    • Intraoperative echocardiography is recommended to assess valvular competency and quality of mitral repair.
    • Once all sutures have been placed on the cuff, the ring may be parachuted down into the annulus. If desired, the ring holder may be used to maintain the shape of the ring while the sutures are tied off. To facilitate ty-ing, the handle may be removed from the ring holder by using a forceps to depress the release button. Once all of the sutures have been tied, the handle may be reattached to the holder to facilitate removal. To remove the ring holder, cut the retaining suture.
    • After the ring has been implanted, depress the release button to remove the ring delivery system. The ring holder should be discarded.
    • CAUTION: To avoid damage to the fabric covering the ring, cutting edge needles and sharp-toothed forceps should not be used during implantation.
    • CAUTION: If an implant suture inadvertently pierces a ring retaining loop, the holder may not release from the ring. To facilitate release, cut the retaining loop suture close to the implant suture. Take care to remove any loose material.

    POTENTIAL SIDE EFFECTS

    As with prosthetic heart valves, serious complications may be associated with the use of this device, sometimes leading to death. Complications necessitating reoperation may occur at varying intervals and include: thrombus hemolysis; ring fracture; left ventricular outflow tract obstruction; systolic anterior motion; damage to coronary arteries; stenosis; uncorrected or recurrent regurgitation; partial or complete dislodgment of the ring from its site of attachment; thromboembolism; A-V block; endocarditis; low cardiac output; and bleeding disorders relating to the use of anticoagulant therapy.

    1. Romano, Mathew A. and Bolling, Steven F., Mitral Valve Repair as an Alternative Treatment for Heart Failure Patients. Heart Failure Monitor, 4(1): 7-12, 2003.
    2. Carpentier, A., Mitral Valve Reconstructive Surgery. Operative Surgery, 3rd Edition. Butterworths Publishers, 169-177, 1977.
    3. Carpentier, A. Cardiac Valve Surgery-The French Correction. J. Thorac. Cardiovasc. Surg., 86:323-377, 1983.

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