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Stay Informed

For Tricuspid Transcatheter-Edge-to-Edge Repair (T-TEER)

CMS Releases Proposed Decision Memo for Tricuspid Transcatheter-Edge-to-Edge Repair (T-TEER)

On April 3, 2025, the Centers for Medicare and Medicare Services (CMS) posted the proposed decision memo for Tricuspid Transcatheter-Edge-to-Edge Repair (T-TEER) and is soliciting public comments on this life-changing therapy. CMS is proposing coverage with evidence development (CED) for FDA-approved indications of TriClip™ patients under the care of a heart team. The proposed heart team includes, at a minimum, cardiac surgeon, interventional cardiologist, cardiologist with training and experience in heart failure management, electrophysiologist, multi-modality imaging specialists, and interventional echocardiographer.

As part of the National Coverage Determination (NCD) process, CMS has opened a 30-day public comment period. This is an opportunity for all stakeholders (physicians, hospital administrators, patients, professional societies, industry, etc.) to provide feedback to CMS on the proposed coverage and how it will impact access for tricuspid regurgitation patients.

Comment Considerations

CMS will be accepting public comments until May 3, 2025 11:59PM ET. Comments may be submitted through the CMS website. Below are some key points to consider including when submitting comments:

  • Your name, profession and affiliation.
  • Description of your clinical practice and/or your institution’s relevant cardiac valve experience including TriClip™ therapy as appropriate.
  • Description of the clinical impact of TriClip therapy within your practice and/or at your institution.
  • Any access challenges faced by your center and the importance of improving access for patients to T-TEER with TriClip Therapy.
  • Your perspective on appropriate members of the heart team.
     

Click Here to Submit Comment to CMS

Questions About the NCD? Contact the Reimbursement Team at Abbott

 

  • Reimbursement Hotline: (855) 569-6430
     

  • Contact the Field Reimbursement Team by email

    Access reimbursement resources for Coding and Coverage, Prior Authorization and Medicare

View reimbursement information

To stay updated on CMS policy and other TriClip TEER updates, please fill out the form below

Reimbursement Contact Information


Reimbursement Hotline

(855) 569-6430


Field Reimbursement Team

E-Mail Us

MAT-2407762 v2.0 | Item approved for U.S. use only.

Important Safety Information

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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