Designed for MAC. Built for Life.
Tendyne™ TMVR is designed for the treatment of symptomatic severe mitral valve dysfunction—including moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate or greater MS—associated with severe MAC. It is intended for patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.1
Product & procedural excellence1
- 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
Learn more about Tendyne™ TMVR
Ordering Information - Tendyne™ TMVR
Valve Product Specifications
| Model | Description | Valve Size | Native Valve Annulus Size | ||||
|---|---|---|---|---|---|---|---|
| AP1 (mm) | PER2 (mm) | ||||||
| TENDV-LP-29S | Tendyne™ Mitral Valve LP | LP | 29S | 26.4 | 29.5 | 101 | 110 |
| TENDV-LP-29L | Tendyne™ Mitral Valve LP | LP | 29L | 26.4 | 29.5 | 110 | 120 |
| TENDV-LP-33S | Tendyne™ Mitral Valve LP | LP | 33S | 29.5 | 33.2 | 111 | 121 |
| TENDV-LP-35M | Tendyne™ Mitral Valve LP | LP | 35M | 31.4 | 35.2 | 122 | 132 |
| TENDV-SP-39M | Tendyne™ Mitral Valve | SP | 39M | 35.0 | 39.3 | 133 | 143 |
1 Anterior to Posterior
2 Perimeter
Apical Pad
| Catalog Number | Description |
|---|---|
| TENDV-SPAD | Tendyne Apical Pad - Small |
| TENDV-LPAD | Tendyne Apical Pad - Large |
Implantation and Retrieval System Product Specifications
| Description | Catalog Number |
|---|---|
| Tendyne™ Loading System | TENDV-LS |
| Tendyne™ Delivery System | TENDV-DS |
| Tendyne™ Pad Position System | TENDV-PS |
| Tendyne™ Retrieval System | TENDV-RS2 |
| Tendyne™ Weight | TENDV-WT |
| Tendyne™ Loading Stand | TENDV-ST |
| Tendyne™ Stand Components | TENDV-SC |
References
- Tendyne™ Instructions for Use.
MAT-2600128 v1.0
Rx Only
Important Safety Information
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.