Tendyne™ (TMVR system)Код изделия (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.
Поставляется под каталожным кодами TENDV-SP-39M, TENDV-LP-29S, TENDV-LP-29L, TENDV-LP-33S, TENDV-LP-35M.
Размеры и характеристики
- 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
Производитель: Abbott Laboratories · Источник данных: cardiovascular.abbott
Конструкция и технологии
Технические характеристики и схемы согласно публикациям Abbott.
Designed for the mitral anatomy to eliminate MR
Идентификация и характеристики изделия
Референсные идентификаторы для закупок, регистрации и тендерной документации.
| Код изделия | TENDV-SP-39M |
|---|---|
| Номера REF | TENDV-SP-39M, TENDV-LP-29S, TENDV-LP-29L, TENDV-LP-33S, TENDV-LP-35M |
| Производитель | Abbott Laboratories |
| Бренд | Abbott |
| Семейство изделий | Транскатетерные клапанные технологии |
| Доступность по странам | Таджикистан, Афганистан |
Клиническое применение
Tendyne™ (TMVR system) — это repositionable, retrievable transcatheter mitral valve replacement (tmvr) system семейства «Транскатетерные клапанные технологии» производства Abbott Laboratories, применяемое специалистами по интервенционным вмешательствам в процедурах, где показано repositionable, retrievable transcatheter mitral valve replacement (tmvr) system данного класса. Поставляется в 5 конфигурациях (каталожные коды с TENDV-SP-39M по TENDV-LP-35M) для соответствия анатомическим и процедурным требованиям.
Полные показания к применению, противопоказания и инструкцию по применению (IFU) — официальную документацию Abbott — можно запросить у нашей клинической команды. Modern Medical Solutions поставляет Tendyne™ (TMVR system) в больницы и катетеризационные лаборатории по всему Таджикистану и Афганистану.
Информация для заказа
Каталожные референсные коды согласно публикациям Abbott. Свяжитесь с нами, чтобы уточнить текущее наличие.
| 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.
Документация и материалы
Инструкцию по применению (IFU), технические спецификации и клиническую литературу по Tendyne™ (TMVR system) можно запросить у нашей клинической команды.
Запросить документациюЧасто задаваемые вопросы
- 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.
