Tendyne™ (TMVR system)Рамзи маҳсулот (REF): TENDV-SP-39M
Tendyne™ transcatheter mitral valve replacement (TMVR) improves 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, and is performed as a beating-heart procedure without the need for cardiopulmonary bypass or rapid pacing. Reported clinical outcomes include complete MR elimination in 99% of patients at 30 days, sustained MR elimination in 93% of patients at 2 years, a 96% technical success rate (per Mitral Valve Academic Research Consortium, MVARC), significant improvement in symptom and quality-of-life measures, and a low mean mitral gradient of 3.2 mm Hg at 2 years. The system is fully repositionable and retrievable at any point intraprocedurally. The Tendyne™ valve is designed for the mitral anatomy to eliminate MR and is supplied in SP and LP models across a range of valve numbers — 39M, 29S, 29L, 33S and 35M — with device AP dimensions from 29.0 to 38.5 mm and effective orifice areas up to 3.0 cm². The implantation and retrieval system comprises the Tendyne™ loading, delivery, pad position and Gen 2 retrieval systems; the delivery and retrieval systems use a 36 F sheath ID.
Таҳти рамзҳои маҳсулот TENDV-SP-39M, TENDV-LP-29S, TENDV-LP-29L, TENDV-LP-33S, TENDV-LP-35M дастрас аст.
Андозаҳо ва хусусиятҳо
- Therapy
- Transcatheter mitral valve replacement (TMVR)
- Valve models
- SP (39M) and LP (29S, 29L, 33S, 35M)
- Device AP
- 29.0–38.5 mm
- Effective orifice area
- 2.2–3.0 cm²
- Delivery/retrieval sheath ID
- 36 F
Истеҳсолкунанда: Abbott Laboratories · Манбаи маълумот: cardiovascular.abbott
Тарҳ ва технология
Хусусиятҳои техникӣ ва диаграммаҳо тибқи нашрияҳои Abbott.
Designed for the mitral anatomy to eliminate MR
Муайянкунӣ ва хусусиятҳои маҳсулот
Идентификаторҳои истинодӣ барои харид, бақайдгирӣ ва ҳуҷҷатҳои тендерӣ.
| Рамзи маҳсулот | TENDV-SP-39M |
|---|---|
| Рақами REF | TENDV-SP-39M, TENDV-LP-29S, TENDV-LP-29L, TENDV-LP-33S, TENDV-LP-35M |
| Истеҳсолкунанда | Abbott Laboratories |
| Бренд | Abbott |
| Оилаи маҳсулот | Технологияҳои транскатетерии клапанҳо |
| Дастрасӣ аз рӯи кишварҳо | Тоҷикистон, Афғонистон |
Истифодаи клиникӣ
Tendyne™ (TMVR system) як repositionable, retrievable transcatheter mitral valve replacement (tmvr) system аз оилаи «Технологияҳои транскатетерии клапанҳо»-и истеҳсоли Abbott Laboratories мебошад, ки аз ҷониби мутахассисони мудохилавӣ дар просессҳое истифода мешавад, ки дар онҳо repositionable, retrievable transcatheter mitral valve replacement (tmvr) system-и ин синф нишон дода шудааст. Он дар 5 конфигуратсия (рамзҳои каталогӣ аз TENDV-SP-39M то TENDV-LP-35M) барои мутобиқат бо талаботи анатомӣ ва просессӣ пешниҳод мешавад.
Барои нишондодҳои пурраи истифода, зидди нишондодҳо ва дастур оид ба истифода (IFU) ҳуҷҷатҳои расмии Abbott-ро тавассути дастаи клиникии мо дархост кунед. Modern Medical Solutions Tendyne™ (TMVR system)-ро ба беморхонаҳо ва лабораторияҳои катетеризатсионӣ дар саросари Тоҷикистон ва Афғонистон таъмин мекунад.
Маълумот барои фармоиш
Рамзҳои истинодии каталогӣ тибқи нашрияҳои Abbott. Барои тасдиқи мавҷудияти ҷорӣ бо мо тамос гиред.
| Model | Valve Number | Catalog Number | Device AP (mm) | Device IC (mm) | Device Perimeter (mm) | EOA (cm²) |
|---|---|---|---|---|---|---|
| SP | 39M | TENDV-SP-39M | 38.5 | 50.5 | 156 | 3.0 |
| LP | 29S | TENDV-LP-29S | 29.0 | 42.5 | 119 | 2.2 |
| LP | 29L | TENDV-LP-29L | 29.0 | 47.5 | 129 | |
| LP | 33S | TENDV-LP-33S | 32.5 | 43.5 | 130 | |
| LP | 35M | TENDV-LP-35M | 34.5 | 48.5 | 144 |
Model, valve number and catalog numbers transcribed from the Abbott Tendyne™ TMVR Ordering Information section (valve product specifications and implantation/retrieval system). Item approved for OUS use only.
Ҳуҷҷатҳо ва маводҳо
Дастур оид ба истифода (IFU), варақаҳои техникӣ ва адабиёти клиникӣ барои Tendyne™ (TMVR system) аз рӯи дархост аз дастаи клиникии мо дастрас аст.
Дархости ҳуҷҷатҳоСаволҳои зуд-зуд додашаванда
- Who is Tendyne™ TMVR intended for?
- Tendyne™ transcatheter mitral valve replacement is intended for select patients with symptomatic, significant mitral regurgitation (MR ≥ grade 3), offering a less invasive mitral valve replacement option over conventional mitral valve surgery.
- Is the Tendyne™ procedure performed on cardiopulmonary bypass?
- No. Tendyne™ TMVR is a beating-heart procedure performed without the need for cardiopulmonary bypass or rapid pacing. The system is also fully repositionable and retrievable at any point intraprocedurally.
- What are the reported clinical outcomes for Tendyne™?
- Reported outcomes include complete MR elimination in 99% of patients at 30 days, sustained MR elimination in 93% of patients at 2 years, a 96% technical success rate (per MVARC), and a low mean mitral gradient of 3.2 mm Hg at 2 years, with significant improvement in symptom and quality-of-life measures.
- What valve sizes and delivery components are available?
- The valve is supplied in SP (39M) and LP (29S, 29L, 33S, 35M) models with device AP dimensions from 29.0 to 38.5 mm and EOA up to 3.0 cm². The implantation and retrieval system includes the Tendyne™ loading system (TENDV-LS), delivery system (TENDV-DS), pad position system (TENDV-PS) and Gen 2 retrieval system (TENDV-RS2); the delivery and retrieval systems use a 36 F sheath ID.
