Skip to main content
Edwards Lifesciences Logo

Let’s turn the page on mitral regurgitation

Mitral Regurgitation (MR) is a common yet undertreated disease, but the next chapter in MR treatment is here. By identifying the disease and referring your patients to a Heart Team, you can help them move toward a treatment path that's right for them.

Your role in identifying and referring patients with mitral regurgitation early is critical to ensuring your patients get the treatment they need.

MR is the backward flow of blood during left ventricular systole, which can lead to progressive symptoms if left untreated. Structural changes to the heart can lead to atrial fibrillation (AFib), heart failure (HF), and pulmonary hypertension (PH).1

Degenerative MR (DMR) 2
Degenerative MR (DMR) 1
1.7%
9.3%

MR is characterized by two distinct etiologies:

Degenerative MR (DMR)

Any MR resulting from structural deformity or damage to the leaflets, chordae, or papillary muscles, causing leaflets to close insufficiently during systole.3

The most common cause of DMR is mitral valve prolapse, which is defined by a spectrum
of lesions.4

MR-etilogies

Functional MR (FMR)

Any MR resulting from left ventricle or left atrium abnormalities/disease. There are no structural problems with the valve apparatus itself.3 Significant FMR has been shown to develop in around half of patients with myocardial infarction and up to 50% of patients with HF.5 

Isolated moderate or severe MR is associated with reduced survival and often goes untreated.6,7

24 million

MR is the most common form of valvular heart disease (VHD), affecting 24.2 million people.8,9

5 million

It is estimated that 5 million people in the US will be diagnosed with MR by 2030.10

54%

Many patients with severe MR go untreated, post 2 years diagnosis.11

Learn more about MR

Treatment options to address MR

For severe symptomatic DMR, surgical mitral valve repair is the preferred choice for patients who are operable, not high risk, and where the results are expected to be durable. Mitral valve repair is associated with better survival than mitral valve replacement.12 Effective treatment for FMR starts with guideline-directed medical therapy (GDMT).12 For patients with severe FMR who remain symptomatic despite GDMT, surgery is recommended.12

Severe DMR12

  • Surgical mitral valve repair or replacement
  • TEER
  • TMVR

FMR12

  • GDMT as initial approach for all patients with FMR
  • For patients with chronic, severe FMR who remain symptomatic despite GDMT:
    • Surgical intervention
  • TEER*
  • TMVR
Learn more about current treatment options

*There are no Edwards M-TEER products that are indicated for the transcatheter treatment of functional mitral regurgitation in the United States

The next chapter in MR treatment is here

What is Transcatheter Edge-to-Edge Repair (TEER)?

Mitral transcatheter edge-to-edge repair (M-TEER), also referred to as transcatheter mitral valve repair (TMVr), is a percutaneous catheter-based approach that aims to restore mitral valve leaflet coaptation, thus reducing MR.13*

Learn more about TEER

*There are no Edwards M-TEER products that are indicated for the transcatheter treatment of functional mitral regurgitation in the United States

Pascal Platform

Recommendations for MR care12

2020 ACC/AHA Clinical Active Guideline for Management of Patients with Valvular Heart Disease (VHD)

Class of
Recommendation

Patients with severe VHD should be evaluated by a Multidisciplinary Heart Valve Team (MDT) when intervention is considered.

2a Class of
Recommendation

Consultation with or referral to a Primary or Comprehensive Heart Valve Center is reasonable when treatment options are being discussed for:

  • Asymptomatic patients with severe VHD
  • Patients who may benefit from valve repair versus valve replacement
  • Patients with multiple comorbidities for whom valve intervention is being considered

“A mitral transcatheter edge-to-edge repair is of benefit to patients with severely symptomatic primary mitral regurgitation who are at high or prohibitive risk for surgery... ”

— 2020 ACC/AHA Guideline for the Management of Valvular Heart Disease
Learn about patient eligibility
Discover more

Help your patients start a new chapter - today

Discover a wealth of resources designed to deepen your understanding of MR and its treatment options. Stay informed with our upcoming symposium announcements, access insightful discussions through our on-demand webinars, and explore the extensive TEER body of evidence. 
Ready to learn more?
Access our resources
Exclusive resources of MR

References

  1. Penn Medicine. Mitral valve regurgitation. Accessed 10 April 2025, https://www.pennmedicine.org/for-patients-and-visitors/patientinformation/conditions-treated-a-to-z/mitralvalve%20regurgitation?gh_jid=5107829003&wtime={seek_to_second_number}.
  2. Zinoviev R, Hasan RK, Gammie JS, Resar JR, Czarny MJ. Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland. J Am Heart Assoc. 2023;12(1):e029875. doi:10.1161/JAHA.123.029875.
  3. Douedi S, Douedi H. Mitral Regurgitation. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2025. Available from: https://www.ncbi.nlm.nih.gov/books/NBK553135/.
  4. Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. European Heart Journal. 2010;31(16):1958-1966. https://doi.org/10.1093/eurheartj/ehq222
  5. Vajapey R, Kwon D. Guide to functional mitral regurgitation: A contemporary review. Cardiovasc Diagn Ther. 2021;11(3):781–92. doi:10.21037/cdt-20-277.
  6. 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):1358–65. doi:10.1093/eurheartj/ehm001.
  7. Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: A community cohort study. Lancet. 2018;391(10124):960–9. doi:10.1016/
s0140-6736(18)30473-2.
  8. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  9. Coffey S, Roberts-Thomson R, Brown A et al. Global epidemiology of valvular heart disease. Nat Rev Cardiol 2021;18:853-864.
  10. De Backer O et al. Circ Cardiovasc Interv. 2014
  11. Sharma, R, Cubeddu, R, Genereux, P. et al. TCT-447 Contemporary Practice Patterns and Outcomes for Patients With Mitral Regurgitation: Results From a Large Multicenter Real-World Database. JACC. 2023 Oct, 82 (17_Supplement) B179–B180. https://doi.org/10.1016/j.jacc.2023.09.456
  12. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e72–227. doi:10.1161/CIR.0000000000000923
  13. Centers for Medicare & Medicaid Services. Transcatheter Edge-to-Edge Repair (TEER). 2024. Available at: https://www.cms.gov/medicare/coverage/evidence/edge-to-edge-repair-teer [Accessed 13 March 2025].
Important Safety Information

Important Safety Information

Edwards PASCAL Precision Transcatheter Valve Repair System



Indications: The PASCAL Precision transcatheter valve repair system (the PASCAL Precision 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 MR.



Contraindications: The PASCAL Precision system is contraindicated in patients with the following conditions: patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; untreatable hypersensitivity or contraindication to nitinol alloys (nickel and titanium) or contrast media; active endocarditis of the mitral valve; rheumatic etiology for mitral regurgitation; evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.



Warnings: The devices are designed, intended, and distributed for single use only. There are no data to support the sterility, non-pyrogenicity, and functionality of the devices after reprocessing. Devices should be handled using standard sterile technique to prevent infection. Do not expose any of the devices to any solutions, chemicals, etc., except for the sterile physiological and/or heparinized saline solution. Irreparable damage to the device, which may not be apparent under visual inspection, may result. Do not use any of the devices in the presence of combustible or flammable gases, anesthetics, or cleaners/disinfectants. Do not use the devices if the expiration date has elapsed. Do not use if the packaging seal is broken or if the packaging is damaged for sterile devices. Do not use if any of the devices were dropped, damaged or mishandled in any way. Standard flushing and de-airing technique should be used during preparation and throughout procedure to prevent air embolism.


As with any implanted medical device, there is a potential for an adverse immunological response. Serious adverse events, sometimes leading to surgical intervention and/or death, may be associated with the use of this system ("Potential Adverse Events"). A full explanation of the benefits and risks should be given to each prospective patient before use. Careful and continuous medical follow-up is advised so that implant-related complications can be diagnosed and properly managed. Anticoagulation therapy must be determined by the physician per institutional guidelines.


Precautions: Prior to use, patient selection should be performed by a heart team to assess patient risk and anatomical suitability. After use, short-term anticoagulation therapy may be necessary after valve repair with the PASCAL Precision system. Prescribe anticoagulation and other medical therapy per institutional guidelines.

Potential Adverse Events: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the PASCAL Precision system: death; abnormal lab values; allergic reaction to anesthetic, contrast, heparin, Nitinol; anemia or decreased hemoglobin (may require transfusion); aneurysm or pseudoaneurysm; angina or chest pain; anaphylactic shock; arrhythmias – atrial (i.e. atrial fibrillation, Supraventricular tachycardia); arrhythmias – ventricular (i.e. ventricular tachycardia, ventricular fibrillation); arterio-venous fistula; atrial septal injury requiring intervention; bleeding; cardiac arrest; cardiac failure; cardiac injury, including perforation; cardiac tamponade/pericardial effusion; cardiogenic shock; chordal entanglement or rupture that may require intervention; coagulopathy, coagulation disorder, bleeding diathesis; conduction system injury which may require permanent pacemaker; deep vein thrombosis (DVT); deterioration of native valve (e.g., leaflet tearing, retraction, thickening); dislodgement of previously deployed implant; dyspnea; edema; electrolyte imbalance; emboli/embolization including air, particulate, calcific material, or thrombus; endocarditis; esophageal irritation; esophageal perforation or stricture; exercise intolerance or weakness; failure to retrieve any PASCAL Precision system components; fever; gastrointestinal bleeding or infarct; heart failure; hematoma; hemodynamic compromise; hemolysis; hemorrhage requiring transfusion or intervention; hypertension; hypotension; implant deterioration (wear, tear, fracture, or other); implant embolization; implant malposition or failure to deliver to intended site; implant migration; implant thrombosis; infection; inflammation; LVOT obstruction; mesenteric ischemia; multi-system organ failure; myocardial infarction; native valve injury; native valve stenosis; nausea and/or vomiting; need for open surgery (conversion, emergent or nonemergent reoperation, explant), nerve injury neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke; non-neurological thromboembolic events; pain; papillary muscle damage; paralysis; PASCAL Precision system component(s) embolization; peripheral ischemia; permanent disability; pleural effusion; pulmonary edema; pulmonary embolism; reaction to anti-platelet or anticoagulation agents; renal failure; renal insufficiency; respiratory compromise, respiratory failure, atelectasis, pneumonia – may require prolonged ventilation; retroperitoneal bleed; septal damage or perforation; septicemia, sepsis; skin burn, injury or tissue changes due to exposure to ionizing radiation; single leaflet device attachment (SLDA); stroke; syncope; transient ischemic attack (TIA); urinary tract infection and/or bleeding; valvular regurgitation; vascular injury or trauma, including dissection or occlusion; vessel spasm; ventricular wall damage or perforation; worsening native valve regurgitation / valvular insufficiency; worsening of heart failure; wound dehiscence, delayed or incomplete healing.



CAUTION: US law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.




© 2026 Edwards Lifesciences Corporation. All rights reserved. PP--US-11725v1.0