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TOOLS & RESOURCES

HEART VALVES APP

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In your work, every detail matters. Every day.

Explore the Heart Valves app, a rich resource filled with detailed information about our transcatheter and surgical valves:

  • Product dimensions and accessories
  • Technical product information
  • Product images and videos
  • EOAi calculators
  • Resources and more 

Ready to explore? Download now:

Discover comprehensive heart valve information at your fingertips

Introducing the Heart Valves app, designed specifically for healthcare professionals to streamline their workflow and enhance patient care. This innovative app allows you to quickly and easily locate, calculate, print, share and favorite essential product information. 

Watch our video to learn more.

 

DOWNLOAD THE HEART
VALVES APP TODAY

Available below, or from your favorite app plattform

MAT-2505508 v1.0 | Item approved for U.S. use only.

Important Safety Information
  • SÉGUIN RING
  • Navitor
  • Regent
  • Epic Max

  • Rx Only

    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.

  • Rx Only

    NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

    INDICATIONS

    The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

    CONTRAINDICATIONS  

    The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

    POTENTIAL ADVERSE EVENTS  

    Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

  • Rx Only

    REGENT™ MECHANICAL HEART VALVE

    INDICATION FOR USE

    The SJM Regent™ Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic valve.

    CONTRAINDICATIONS

    The SJM Regent™ Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    POTENTIAL ADVERSE EVENTS

    Complications are associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, heart failure or death. Any of these complications may require reoperation or explantation of the device.

  • Rx Only

    EPIC™ MAX STENTED PORCINE TISSUE VALVES

    INDICATIONS FOR USE

    The Epic™ Max valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve. 

    CONTRAINDICATIONS

    None known. 

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include: angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage, anticoagulant/antiplatelet-related; leak, transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; valve thrombosis. It is possible that these complications could lead to: reoperation; explantation; permanent disability; death. 

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