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Conditions

VALVULAR HEART DISEASE

Mitral regurgitation and aortic stenosis are two of the most prevalent valve diseases, affecting millions of patients worldwide. The latest treatment guidelines recommend timely intervention to help ensure better patient outcomes and survival, including transcatheter and surgical options to repair or replace the valve.1

MITRAL REGURGITATION (MR)

MR is the most frequent valve disease in the United States.2,3 Over 4 million people have significant MR, with an annual incidence of 250,000.2-4 Approximately 30,000 of these patients undergo surgery each year in the United States.5 The disease affects millions of people worldwide.

 
+4M
PEOPLE HAVE
SIGNIFICANT MR

 
250K
new cases
annually

ONLY
30K
UNDERGO
SURGERY EACH YEAR

1-YEAR MORTALITY UP TO 57%9

Mitral Regurgitation Is a Prevalent and Progressive Disease



Mitral Regurgitation Is a Prevalent and Progressive Disease

MR is the most frequent valve disease in the United States.2,3 If left untreated, MR initiates a cascade of events progressing to heart failure, then death.6-8

  • There are two types of Mitral Regurgitation6

    Degenerative MR, also called primary MR, is caused by damage to the mitral valve apparatus with prolapse or flail of the leaflets. It can be related to age, a birth defect, or underlying heart disease. Functional MR, also called secondary MR, is caused by enlargement of the heart due to heart attack or heart failure.

    Primary MR, or degenerative MR, prolapse of the leaflets

    Primary MR (Degenerative MR): Prolapse 

    Primary MR, or degenerative MR, flail of the leaflets

    Primary MR (Degenerative MR): Flail 

    Secondary MR, or functional MR

    Secondary MR (Functional MR)

  • Symptoms of Mitral Regurgitation1,12

    Symptoms are usually those of heart failure: fatigue, dyspnea, orthopnea, edema, and palpitations.

    With left ventricular (LV) enlargement, there is an increase in pulmonary artery pressure and venous pressure, and eventually LV compensation fails. 

    Auscultation findings include:

    • Notable S1 
    • S3 at the apex, indicating a dilated left ventricle and severe mitral regurgitation

    The S3 often suggests a dilated left ventricle and progression to heart failure.

  • 2020 AHA/ACC guideline for valvular heart disease include the following key highlights related to Transcatheter Edge-to-Edge Repair (TEER, also known as TMVr) for Mitral Regurgitation1

    As the world's first TEER therapy, MitraClip™ is the only US-approved TEER for both of the following etiologies in treating moderate-to-severe or severe symptomatic MR, and ​has served as the foundation for TEER recommendations:

    A. Primary Mitral Regurgitation (PMR, formerly Degenerative MR)

    • TEER upgraded and is reasonable for treating severely symptomatic patients with PMR, at high or prohibitive surgical risk, mitral valve anatomy suitable for repair and life expectancy ≥ 1 year (Class 2a from Class 2b,
      LOE B)

    B. Secondary Mitral Regurgitation (SMR, formerly Functional MR)

    • TEER is now reasonable in severe secondary MR patients with persistent symptoms despite optimal GDMT* and whose LVEF is 20-50%, LVESD ≤ 70 mm, and systolic PAP ≤ 70 mmHg (Class 2a, LOE B, New).

    *Includes sacubitril/valsartan (ARNI, Entresto) and biventricular pacing as indicated.

Robert Farivar, MD, PhD

”There’s a large population of these patients that are not good surgical candidates. A lot of that age plays a role into, that increases our risk exponentially. One way to remove that risk is through a therapy like MitraClip.”*

Robert Farivar, MD, PhD
Medical Director of Cardiothoracic Surgery
Saint Alphonsus, Boise, Idaho

*The testimonials does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others. 

For many, surgery is contraindicated
and medications are not sufficient

MR patients who most need intervention are often the most likely to be denied surgery.10

49% denied surgery

Effective intervention is possible for your patients with significant MR

Select patients with significant MR now have more options for effective treatment: not only surgical mitral valve replacement or repair, but transcatheter mitral valve repair (TMVr) as well.

AORTIC STENOSIS

The growing prevalence of aortic stenosis and the latest therapy guidelines

Aortic stenosis represents 34% of the native valvular diseases in industrialized nations, and is the most common primary valve disease requiring surgery or transcatheter intervention in Europe and North America.11,12 Of the 146,304 deaths in the U.S. from aortic valve disease (ICD-10 data from 1999 to 2009), 82.7% were from aortic stenosis.2

Due to the aging population, aortic stenosis prevalence is growing: the number of elderly patients with calcific aortic stenosis is projected to more than double by 2050 in both the U.S. and Europe.2

~50%

MORTALITY
AT 2 YEARS

From the onset of symptoms, risk of mortality from aortic valve stenosis is approximately 25% at 1 year and 50% at 2 years if patients, who are already medically treated, do not undergo aortic valve replacement–this is because replacement is the only effective treatment.13,14

>50%

sudden
cardiac deaths

Among this same patient subset, more than 50% of deaths are sudden cardiac deaths, if the obstructed valve remains unrelieved.13 It is theorized that the fatal arrhythmias that precede aortic valve stenosis are secondary to inadequate blood flow through the aortic valve into the coronary arteries.15

~90K

aortic valve
prostheses implanted

Each year, approximately 90,000 aortic valve prostheses are implanted in the U.S. Worldwide, the figure is 280,000, and by 2050 the number is expected to reach 850,000 annually.16

Referrals to cardiovascular specialists

Due to enhanced awareness of various treatments, referring physicians are sending more patients with valve disease, such as aortic stenosis, to cardiovascular specialists, where they can offer patients improved noninvasive imaging tests and greater expertise in interventions. When patients with valve disease are referred for intervention in a timely manner, they can experience better outcomes in terms of preserved ventricular function as well as survival rates.

  • Types of aortic stenosis

    There are 4 stages of aortic stenosis14:

    • Stage A: At risk of stenosis
    • Stage B: Progressive stenosis
    • Stage C: Severe asymptomatic stenosis
    • Stage D: Severe symptomatic stenosis

    There is an additional category of “very severe” stenosis based on studies of the natural history of the disease, showing that prognosis becomes poorer as the severity of stenosis increases, and the event-free survival can be 50% at 2 years.

    Consequently, patients with asymptomatic severe aortic stenosis require frequent monitoring for progression because symptom onset may be insidious and not well recognized by the patient. An increase in hemodynamic severity is inevitable once even mild stenosis is present.

    Normal aortic valve without stenosis

    Normal

    Mild to moderate aortic stenosis

    Mild-to-moderate aortic stenosis

    Severe aortic stenosis

    Severe aortic stenosis

  • Risk factors

    Regarding Stage A, there are certain patient characteristics that reflect risk factors for progression of aortic stenosis, including baseline valve area, degree of valve calcification, older age, history of smoking, and male sex. Other risk factors include presence of bicuspid vs tricuspid involvement, coronary artery disease, mitral annular calcification, hypercholesterolemia, higher body mass index, renal insufficiency, hypercalcemia, metabolic syndrome, and diabetes.2

  • Pathophysiology of aortic stenosis

    Elevated left ventricular systolic blood pressure accompanies aortic stenosis, yet compensatory mechanisms include LV hypertrophy and atrial augmentation of preload—so cardiac output can be maintained for many years. As the disease worsens, these adaptations become inadequate and the patient may eventually develop symptoms of decreased cardiac output and heart failure.13

  • Symptoms of aortic stenosis–signaling need for aortic valve replacement

    Due to the often slow, progressive nature of aortic stenosis, patients may not recognize symptoms because they may have gradually limited their daily activity levels. Typical initial symptoms are dyspnea on exertion or decreased exercise tolerance.6

    Most patients with aortic stenosis are first diagnosed when cardiac auscultation reveals a systolic murmur; there also tends to be diminished or absent S2. Patient symptoms which are late manifestations of the disease include13:

    • Angina pectoris typically upon physical exertion
    • Heart failure symptoms such as paroxysmal nocturnal dyspnea, orthopnea, dyspnea on exertion, and shortness of breath
    • Syncope, often upon exertion when systemic vasodilatation in the presence of a fixed forward stroke volume causes the arterial systolic blood pressure to drop
    • Systolic hypertension

    Symptomatic patients with severe aortic stenosis should be re-evaluated at least every 6 months to determine if there is a change in symptoms such as exercise tolerance.12

  • 2020 AHA/ACC guideline for valvular heart disease including the following key highlights related to TAVI (previously TAVR)

    A. Symptomatic Severe Aortic Stenosis

    1. Choice of intervention should be a shared decision that considers patient preference, lifetime risks (e.g., long term anticoagulation) and benefits of valve type (mechanical vs bio-prosthetic) and approach (surgery vs transcatheter) (Class I).
    2. Choice of SAVR vs TAVI bio-prosthesis should be based on symptoms, tolerance for VKA anticoagulation, patient age, life expectancy, approved indication, anatomy suited for transfemoral TAVI, and surgical risk (TAVI vs palliative) (Class I).

    B. Asymptomatic Severe Aortic Stenosis

    1. TAVI or SAVR is recommended for those with LVEF<50% whose age ≤ 80 years, and concomitant with other cardiac surgery after consideration by a heart team following recommendation A.1 (Class I).

    C. TAVR Valve-in-Valve

    • A transcatheter valve-in-valve procedure is reasonable for severely symptomatic patients due to bioprosthetic aortic valve dysfunction (stenosis or regurgitation) and at high or prohibitive surgical risk, and if performed at a comprehensive valve center (Class 2a).

    D. Anticoagulation

    • VKA is recommended for patients with mechanical SAVR to achieve INR of 2.5 (without thromboembolism risks) or INR 3.0 (with thromboembolism risks) (Class I).
    • Single APT for bio-prosthetic SAVR or TAVR patients may be considered in the absence of indications for oral anticoagulation (Class 2a).
    • Oral anticoagulation is reasonable up to 6 months for bio-prosthetic SAVR in low bleeding risk patients (Class 2a).
    • VKA may be reasonable to achieve INR 1.5-2.0 in patients with On-X AVR and no thromboembolism risks (Class 2b).

    E. Diagnosis of valve prosthesis issues

    • Multimodality imaging with transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), fluoroscopy, and/or computed tomography (CT) scanning is recommended to detect and characterize valve function, leaflet motion and extent of thrombus if present (Class I).

Intervention: SAVR and TAVR

There are many new developments in the field of aortic valve disease related to patients’ natural history, advances in diagnostic imaging, and improvements in catheter-based and surgical interventions.8 TAVI (transcatheter aortic valve implantation), also referred to as TAVR (transcatheter aortic valve replacement), is an effective therapy for whom surgery is not an option, as well as an alternative for high-risk patients.17

The strongest indication for intervention is the presence of symptoms. In patients with severe, symptomatic, and calcific aortic stenosis, the only effective treatments include surgical aortic valve replacement (SAVR) or TAVR—since there is a high risk of death if valve replacement is not performed.14

Even otherwise healthy patients with severe, symptomatic stenosis should nearly always be considered for intervention.6  The choice of proceeding with SAVR vs TAVI is based on multiple factors, including the surgical risk, comorbidities, patient frailty, and patient preferences.1


USE OF TAVI HAS INCREASED MARKEDLY
SINCE ITS APPROVAL IN 2011 WITH
4,627 PROCEDURES

documented in 2012, 34,892 in 2016, and nearly 90,000 total procedures during that time frame.18 TAVI patients are typically older (median age 83 years)18 and at higher procedural risk than those undergoing SAVR—in other words, patients who otherwise may not have received surgical treatment due to their age and risk profile.


DATA FROM THE U.S. REVEALED THAT THE INITIAL LENGTH OF STAY WAS AN AVERAGE OF 4.4 DAYS SHORTER

for patients treated with TAVI compared to SAVR. TAVI also reduced the need for rehabilitation services at discharge and was associated with improved 1-month quality-of-life indicators.2

Medical therapy for aortic stenosis

For aortic stenosis patients, medical therapy alone cannot improve outcomes compared with the natural history of the disease.

Bicuspid aortic valve

Most patients with a bicuspid aortic valve will develop aortic stenosis or aortic regurgitation over their lifetime. In 20%-30% of patients with bicuspid valves, other family members also have bicuspid valve disease and/or a related aortic abnormality. There are no proven drug therapies that have been shown to reduce the rate of progression of aortic dilation in patients with aortopathy associated with bicuspid aortic valve.14

TRICUSPID REGURGITATION (TR)

TR is highly prevalent and undertreated2

In the United States, approximately 1 in 30 people over the age of 65 has significant TR.1 Compared to other valve diseases, TR is one of the most undertreated valvular pathologies, with less than 0.6% of the affected population receiving treatment.2-6

1.6M

TR PATIENTS3

<0.6%

TREATED†


†Calculations performed by Abbott based on: Enriquez-Sarano M, et al. Prog Cardiovasc Dis. 2019.2

  • Severe TR damages other organs, and can lead to multi-organ dysfunction20
  • Patients with severe TR have significantly impaired quality of life

    Patients with symptomatic, severe TR often experience symptoms such as21:

  • Medical management for TR has little impact on TR reduction22

    Surgery for TR is rarely performed and is associated with high in-hospital and operative mortality and post-procedure adverse events23,24

    Factors prohibiting surgery include:

    • Limited clinical evidence25
    • High surgical risk (8%–13% operative mortality)25
    • Multiple comorbidities25
    • Advanced age25
    • High rate of adverse events23,24

MAT-2114617 v8.0 | Item approved for U.S. use only.

References
  1. Nishimura RA, Otto CM, Bonow RO, et al.  2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.  Circulation.  2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932
  2. Benjamin EJ, Virani SS, Callaway CW, et al. Heart Disease and Stroke Statistics—2018 Update. A Report From the American Heart Association. Circulation. 2018;137:e67–e492. Doi: 10.1161/CIR.0000000000000558
  3. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
  4. US Census Bureau. 2012-2016 American Community Survey Census Bureau 5-Year Estimates. factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml. Accessed July 23, 2018.
  5. 2019 National Database STS.
  6. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):2438-2488.
  7. Grigioni F, Tribouilloy C, Avierinos JF, et al. MIDA Investigators. Outcomes in mitral regurgitation due to flail leaflets: a multicenter European study. JACC Cardiovasc Imaging. 2008;1(2):133-141.
  8. Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005;352(9):875-883.
  9. Cioffi G, Tarantini L, De Feo S, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117.
  10. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.
  11. Capoulade R, et al. Assessment of aortic valve disease: role of imaging modalities. Curr Treat Options Cardio Med. 2015;17: 49. doi: 10.1007/s11936-015-0409-7.
  12. Baumgartner H, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739–2791. doi:10.1093/eurheartj/ehx391.
  13. Ren X. Aortic stenosis. MedScape. emedicine.medscape.com/article/150638-overview. Published March 23, 2017.
  14. Nishimura RA, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2440-2492. doi: 10.1161/CIR.0000000000000029.
  15. Kulick DL. Aortic valve stenosis symptoms, treatment, types, and surgery. MedicineNet. www.medicinenet.com/aortic_stenosis/article.htm. Reviewed November 13, 2017.
  16. Zenses AS, et al. Prosthetic aortic valves. Encyclopedia of Biomedical Engineering. 2018. doi.org/10.1016/B978-0-12-801238-3.11103-1. Accessed September 17, 2018.
  17. Reinöhl J, et al. Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med. 2015;373(25):2438-2447. doi: 10.1056/NEJMoa1500893.
  18. Messenger, C. John. Trends in United States TAVR Practice.  Cardiac Interventions Today. March/April 2018.
  19. Navitor™ TAVI System IFU.
  20. Henning RJ. Tricuspid valve regurgitation: current diagnosis and treatment. Am J Cardiovasc Dis. 2022;12(1):1-18. Published 2022 Feb 15.
  21. Mayo Clinic. Accessed February 2024. www.mayoclinic.org
  22. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med. 2023;388(20):1833-1842. doi:10.1056/NEJMoa2300525.
  23. Zack CJ, Fender EA, Chandrashekar P, et al. National trends and outcomes in isolated tricuspid valve surgery. J Am Coll Cardiol. 2017;70(24):2953-2960. doi:10.1016/j.jacc.2017.10.039
  24. Chen Q, Bowdish ME, Malas J, et al. Isolated tricuspid operations: The Society of Thoracic Surgeons Adult cardiac surgery database analysis. Ann Thorac Surg. 2023;115(5):1162-1170. doi:10.1016/j.athoracsur.2022.12.041
  25. Enriquez-Sarano M, Messika-Zeitoun D, Topilsky Y, Tribouilloy C, Benfari G, Michelena H. Tricuspid regurgitation is a public health crisis. Prog Cardiovasc Dis. 019;62(6):447-451. doi:10.1016/j.pcad.2019.10.009
Important Safety Information
  • MitraClip
  • Epic Plus
  • Epic Max
  • MASTERS SERIES
  • Regent
  • Navitor
  • TriClip

  • Rx Only

    MITRACLIP DELIVERY SYSTEMS

    INDICATION FOR USE
     

    • The MitraClip™ G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
    • The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding.

  • Rx Only

    EPIC™ PLUS/EPIC™ PLUS SUPRA STENTED PORCINE TISSUE VALVES

    INDICATION FOR USE

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

    The Epic™ Plus Supra 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.

  • 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. 

  • Rx Only

    MASTERS SERIES MECHANICAL HEART VALVE

    INDICATION FOR USE

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

    CONTRAINDICATIONS

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

    POTENTIAL ADVERSE EVENTS

    Complications 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, failure or death. Any of these complications may require reoperation or explantation of the device.

  • 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

    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

    TRICLIP™ G4 SYSTEM

    INDICATION FOR USE

    The TriClip™ G4 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

    CONTRAINDICATIONS

    The TriClip G4 System is contraindicated in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to Implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve.

    POTENTIAL ADVERSE EVENTS

    The following events have been identified as possible complications of the TriClip G4 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment/surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and heparin induced thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy and transesophageal echocardiogram (TEE) related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension/hypertension; Infection including: Septicemia; Nausea or vomiting; Pain; Pericardial effusion; Stroke/cerebrovascular accident (CVA) and transient ischemic attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement/rupture, Single leaflet device attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism).

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