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TMVR

TENDYNE™ TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR)

The first transcatheter mitral valve replacement system approved in the United States to treat symptomatic severe mitral valve dysfunction associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair.

Tendyne™ TMVR has demonstrated consistent Mitral Regurgitation (MR) elimination,* leading to improved mitral valve function and meaningful gains in quality of life.1

Product & procedural excellence

  • Predictable and sustained MR elimination* at 1 year
  • Excellent hemodynamics
  • Quality of life improvement
  • High technical success rate
  • Improvement in heart failure symptoms assessed by NYHA classification

**Elimination of moderate-to-severe and severe MR

Design

  • Transcatheter beating-heart procedure without the need for cardiopulmonary bypass
  • Interprocedurally recapturable, repositionable, and retrievable
  • Tether design enables securement without annular or leaflet fixation
  • Available in five implant sizes to treat patients with varying levels of MAC severity

PATIENTS WHO BENEFIT

Tendyne™ TMVR offers patients with severe mitral valve disease caused by MAC with a new option for safe and effective mitral valve replacement.

Tendyne™ Valve overview

Procedure overview

A delivery system positions the Tendyne valve in the heart via an incision in the left side of the chest.

Once the Tendyne valve is optimally positioned within the mitral annulus, the delivery system is removed.

Applying tension to the tether assists in securing the valve, which is attached to an apical pad placed over the access site.

MAT-2512510 v1.0 | Item approved for U.S. use only.

References
  1. Tendyne Instructions for Use (IFU).
  2. P. Sorajja, et al. Initial Feasibility Study of a New Transcatheter Mitral Prosthesis. JACC Vol 73, No 11, 2019.
Important Safety Information

Rx Only

TENDYNE™ TRANSCATHETER MITRAL VALVE SYSTEM

INDICATIONS FOR USE

The Tendyne™ Transcatheter Mitral Valve System is indicated for the treatment of symptomatic severe mitral valve dysfunction (moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS), or moderate MR with moderate or greater MS) associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.

CONTRAINDICATIONS

The Tendyne™ Transcatheter Mitral Valve System is contraindicated in patients with:

  • anticoagulation/antiplatelet intolerance;
  • sepsis or active endocarditis;
  • evidence of left ventricular or left atrial thrombus at risk of embolization;
  • a thin or fragile apex rendering the subject unsuitable for a transapical procedure; or
  • untreatable hypersensitivity to nickel or titanium

Patients not deemed a candidate by the local heart team based on clinical or anatomical factors should not have the Tendyne™ Transcatheter Mitral Valve procedure.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

Adverse events potentially associated with use of the Tendyne™ Transcatheter Mitral Valve System may include, but are not limited to, the following:

Death, Adverse foreign body response, Adverse reaction to anesthesia, Allergic reaction, Anemia, Annular dissection, Aortic insufficiency, Atrial or ventricular injury, Atrial Septal Defect (resulting from transseptal mitral valvuloplasty, if performed), Bioprosthetic valve dysfunction, Bleeding complications, Blood loss which may require transfusion, Cardiac arrest, Cardiac perforation, Conduction defect with or without need for pacemaker, Cardiac arrhythmia, atrial or ventricular, Damage to cardiac tissue and/or structures, Decreased LV function and/or cardiac output, Device embolism, Device erosion, migration or malposition, Device thrombosis, Embolism (air, blood clot, calcium, tissue, etc.), Endocarditis, Esophageal irritation, stricture, or perforation, Fever, Foreign body response, Heart Failure, new or worsening, Hematoma, Hemolysis, Hypotension, Infection / Sepsis, Leaflet, chordal, papillary or ventricular rupture (resulting from mitral valvuloplasty, if performed), Liver failure, Mitral valve injury, Mitral valve prolapse / stenosis, Myocardial infarction, Obstruction, Pain, Pleural effusion, Pulmonary embolism, Pulmonary hypertension, Paravalvular leak, Pericardial effusion / tamponade, Renal insufficiency or failure, Respiratory difficulty, insufficiency or failure, Stroke or transient ischemic attack, Tear or damage to device, Vascular and access-related complications, Worsening of mitral regurgitation.

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