+
+
Stay Informed

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

Submit Comment to CMS

CMS OPENS NATIONAL COVERAGE ANALYSIS (NCA) FOR TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) THERAPY

On October 3, 2024, the Centers for Medicare and Medicare Services (CMS) opened a National Coverage Analysis (NCA) and is soliciting public comments on this life-changing therapy. Abbott has requested a National Coverage Determination (NCD) to create national coverage criteria and to ensure long-term, predictable, and consistent coverage for all Medicare beneficiaries.

As part of the NCA opening, CMS has initiated a 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 importance of the recent evidence on relevant patient characteristics for identifying coverage candidacy for tricuspid TEER.

The final day to enter comments is November 2, 2024. Once this public comment period closes, CMS will review the totality of clinical evidence on tricuspid TEER and the submitted comments to begin the development of a proposed NCD.

If you would like to submit a comment on the CMS website, please use the "Submit Comment to CMS" button below.

Submit Comment to CMS


If you have reimbursement questions, please contact us or you can call us at  (855) 569-6430.

Support is available from 8 a.m. to 5 p.m. Central Time, Monday through Friday.

More information regarding the NCA can be found on the CMS website.

Additionally, you can visit our website for reimbursement resources such as guides, checklists, reimbursement webinars, and prior authorization resources.

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

MAT-2407762 v1.0 | 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).

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

U.S. VISITOR INTERNATIONAL VISITOR

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

OkCancel
+