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Tendyne™

Transcatheter Mitral Valve Replacement (TMVR)

Trifecta GT

REPLACE. RESTORE. RECLAIM.

Tendyne™ transcatheter mitral valve replacement (TMVR) improves your patients' function and quality of life by offering select patients with symptomatic, significant MR (≥ grade 3) a less invasive mitral valve replacement option over conventional mitral valve surgery. Tendyne TMVR provides symptom relief by eliminating MR.1

  • Beating heart procedure without the need for cardiopulmonary bypass or rapid pacing
  • Complete MR elimination in 99% of patients at 30 days
  • Sustained MR elimination in 93% of patients at 2 years1
  • 96% technical success rate1,*
  • System is fully repositionable and retrievable at any point intraprocedurally
  • Significant improvement in symptom and quality-of-life measures1
  • Low mean mitral gradient of 3.2 mm Hg at 2 years1

*Technical success per Mitral Valve Academic Research Consortium (MVARC).

Designed for the mitral anatomy to eliminate MR

Illustration of the Tendyne mitral valve

Learn more about Tendyne™ TMVR by visiting the Abbott Structural Heart website

View Tendyne TMVR Clinical Data
Abbott Structural Heart Website

Ordering Information - EU MDD3

Valve Product Specifications

 

ModelValve NumberCatalog NumberDevice AP (mm)Device IC (mm)Device Perimeter (mm)EOA (cm2)
SP33STENDV-SP-33S32.543.51303.0
33MTENDV-SP-33M32.546.5136
33LTENDV-SP-33L32.550.5144
35MTENDV-SP-35M34.548.5144
37STENDV-SP-37S36.546.5144
37LTENDV-SP-37L36.552.5156
39MTENDV-SP-39M38.550.5156
41STENDV-SP-41S40.547.5154
LP29STENDV-LP-29S29.042.51192.2
29LTENDV-LP-29L29.047.5129
33STENDV-LP-33S32.543.5130
35MTENDV-LP-35M34.548.5144
37MTENDV-LP-37M36.549.5150


Implantation and Retrieval System Product Specifications

DescriptionCatalog NumberApproximate Dimensions (cm)
Tendyne™ Loading SystemTENDV-LS18 x 9 x 61
Tendyne™ Delivery System*TENDV-DS6.5 x 7.5 x 89
Tendyne™ Pad Position SystemTENDV-PS5 x 7.5 x 38
Tendyne™ Retrieval System*TENDV-RS18 x 10 x 76
Tendyne 2 Lb. WeightTENDV-WTN/A
Tendyne StandTENDV-STN/A
Tendyne Stand ComponentsTENDV-SCN/A


*Sheath ID for the delivery system and retrieval system is 36F.

Ordering Information - EU MDR4

Valve Product Specifications

 

ModelValve NumberCatalog NumberDevice AP (mm)Device IC (mm)Device Perimeter (mm)EOA (cm2)
SP33STENDV-SP-33S32.543.51303.0
33MTENDV-SP-33M32.546.5136
33LTENDV-SP-33L32.550.5144
35MTENDV-SP-35M34.548.5144
37STENDV-SP-37S36.546.5144
37LTENDV-SP-37L36.552.5156
39MTENDV-SP-39M38.550.5156
41STENDV-SP-41S40.547.5154
LP29STENDV-LP-29S29.042.51192.2
29LTENDV-LP-29L29.047.5129
33STENDV-LP-33S32.543.5130
35MTENDV-LP-35M34.548.5144
37MTENDV-LP-37M36.549.5150


Implantation and Retrieval System Product Specifications

DescriptionCatalog NumberApproximate Dimensions (cm)
Tendyne™ Loading SystemTENDV-LS15 x 8 x 49
Tendyne™ Delivery System*TENDV-DS6.5 x 7.5 x 89
Tendyne™ Pad Position SystemTENDV-PS5 x 7.5 x 38
Tendyne™ Gen 2 Retrieval System*TENDV-RS215 x 8 x 45
Tendyne 2 Lb. WeightTENDV-WTN/A
Tendyne StandTENDV-STN/A
Tendyne Stand ComponentsTENDV-SCN/A


*Sheath ID for the delivery system and retrieval system is 36F.


References

  1. Muller D, et al, 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation, J Am Coll Cardiol, 2021;78(19)1847-1859
  2. Apical Pad: Sorajja P, Moat N, Badhwar V, et al. Initial feasibility study of a new transcatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019;73(11):1250-1260.
  3. Tendyne IFU (EU MDD version)
  4. Tendyne IFU (EU MDR version)

 

MAT-2002383 v4.0 | Item approved for OUS use only.

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