SELUTION SLR PTCA Drug Eluting BalloonКод изделия (REF): SC14-275035
The SELUTION SLR PTCA Drug Eluting Balloon represents a shift in coronary intervention technology, intended to go beyond traditional metal implants. Its design philosophy centers on providing a consistent and predictable drug release profile that is intended to be comparable to the latest generation of drug-eluting stents. By utilizing a proprietary phospholipid coating and microreservoir technology, the device is designed to facilitate improved drug uptake and retention within the tissue while minimizing drug loss during the procedural phase. The system is designed to provide sustained limus release for up to 90 days, offering a localized anti-inflammatory effect without the need for a permanent metallic scaffold. This approach supports a hybrid strategy, allowing practitioners to minimize the amount of implanted metal in the vessel. The broader size matrix is designed to extend clinical treatment options for various manifestations of coronary artery disease, supporting complex procedures such as the treatment of long, calcified, or bifurcation lesions. Cordis presents SELUTION SLR as a new paradigm for coronary interventions: breakthrough technology to deliver sustained limus release for up to 90 days. According to Cordis, SELUTION SLR DEB was the first drug-eluting balloon to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA). The device is also being evaluated in the SELUTION DeNovo Study — a prospective, randomized, multi-center, international, single-blind clinical trial comparing a SELUTION SLR DEB strategy versus a drug-eluting stent (DES) strategy in 3,326 patients with 1:1 randomization. Cordis describes it as a landmark randomized trial for coronary de-novo lesions with all-comers enrollment, designed to evaluate non-inferiority at 1 year and possible superiority at 5 years, with target vessel failure at 1 and 5 years as the primary endpoints.
Эта страница содержит сведения о каталожном коде (REF) SC14-275035, одной из 84 доступных конфигураций SELUTION SLR PTCA Drug Eluting Balloon. См. полный обзор SELUTION SLR PTCA Drug Eluting Balloon по каждой конфигурации.
Доступно под кодом(-ами) изделия SC14-150010, SC14-150015, SC14-150020, SC14-150025, SC14-150030, SC14-150035, SC14-150040, SC14-200010 и ещё 76 (см. раздел «Информация для заказа» ниже).
Размеры и технические характеристики
- Balloon diameters
- 1.50 – 5.00 mm (12 diameters)
- Balloon lengths
- 10, 15, 20, 25, 30, 35, 40 mm
- Guide catheter compatibility
- ≥ 5 Fr for 1.50 – 3.75 mm balloons; ≥ 6 Fr for 4.00 – 5.00 mm balloons
Производитель: Cordis · Источник данных: cordis.com
Конструкция и технология
Технические характеристики и схемы согласно публикациям Cordis.
The SELUTION DeNovo Study
A prospective, randomized, multi-center, international, single-blind clinical trial comparing the SELUTION SLR DEB strategy versus a drug-eluting stent (DES) strategy, as described by Cordis. 3,326 patients are randomized 1:1 between the DEB arm (with vessel preparation) and a DES arm per standard of care.
- 1.Landmark randomized trial for coronary de-novo lesions, all-comers enrollment.
- 2.Designed to evaluate non-inferiority at 1 year and possible superiority at 5 years.
- 3.Primary endpoints: target vessel failure at 1 year and 5 years.
Diagram and study description as published by Cordis (SELUTION SLR PTCA product page, cordis.com). Currently enrolling; refer to Cordis for study status and citations.
Особенности изделия
Конструктивные характеристики согласно публикациям Cordis.
Proprietary Phospholipid Coating
Facilitates drug uptake and retention in the tissue while minimizing drug loss during the procedure.
MicroReservoir Technology
Achieves consistent and predictable drug release at therapeutic levels comparable to drug-eluting stents.
Sustained Limus Release
Delivers sustained limus release to the vessel wall for up to 90 days.
Broad Size Matrix
Offers an extensive range of sizes to extend treatment options for coronary artery disease.
FDA Breakthrough Device Designation
According to Cordis, SELUTION SLR DEB was the first drug-eluting balloon to be awarded Breakthrough Device designation by the US FDA.
SELUTION DeNovo Study
A prospective, randomized, multi-center, international, single-blind trial (N = 3,326, 1:1 randomization) comparing a SELUTION SLR DEB strategy versus a drug-eluting stent strategy for coronary de-novo lesions, with target vessel failure at 1 and 5 years as primary endpoints.
Documentation
Official IFU, sizing charts and full specifications are available on request through Azmed Devices.
Идентификация и технические характеристики изделия
Референсные идентификаторы для закупок, регистрации и тендерной документации.
| Код изделия | SC14-275035 |
|---|---|
| Номер(а) REF | SC14-150010, SC14-150015, SC14-150020, SC14-150025, SC14-150030, SC14-150035, SC14-150040, SC14-200010, SC14-200015, SC14-200020, SC14-200025, SC14-200030, SC14-200035, SC14-200040, SC14-225010, SC14-225015, SC14-225020, SC14-225025, SC14-225030, SC14-225035, SC14-225040, SC14-250010, SC14-250015, SC14-250020, SC14-250025, SC14-250030, SC14-250035, SC14-250040, SC14-275010, SC14-275015, SC14-275020, SC14-275025, SC14-275030, SC14-275035, SC14-275040, SC14-300010, SC14-300015, SC14-300020, SC14-300025, SC14-300030, SC14-300035, SC14-300040, SC14-325010, SC14-325015, SC14-325020, SC14-325025, SC14-325030, SC14-325035, SC14-325040, SC14-350010, SC14-350015, SC14-350020, SC14-350025, SC14-350030, SC14-350035, SC14-350040, SC14-375010, SC14-375015, SC14-375020, SC14-375025, SC14-375030, SC14-375035, SC14-375040, SC14-400010, SC14-400015, SC14-400020, SC14-400025, SC14-400030, SC14-400035, SC14-400040, SC14-450010, SC14-450015, SC14-450020, SC14-450025, SC14-450030, SC14-450035, SC14-450040, SC14-500010, SC14-500015, SC14-500020, SC14-500025, SC14-500030, SC14-500035, SC14-500040 |
| Производитель | Cordis |
| Бренд | Cordis |
| Семейство продукции | Коронарные вмешательства |
| Доступность по странам | Азербайджан |
Клиническое применение
SELUTION SLR PTCA Drug Eluting Balloon — это ptca coronary drug eluting balloon в семействе Коронарные вмешательства от Cordis, применяемый специалистами по интервенционным вмешательствам в процедурах, где показано использование ptca coronary drug eluting balloon данного класса. Поставляется в 84 конфигурациях (каталожные коды с SC14-150010 по SC14-500040) для соответствия анатомическим и процедурным требованиям.
Для получения полного перечня показаний к применению, противопоказаний и инструкции по применению (IFU) запросите официальную документацию Cordis через нашу клиническую команду. Azmed Devices поставляет SELUTION SLR PTCA Drug Eluting Balloon больницам и клиникам по всему Азербайджану.
Информация для заказа
Каталожные референсные коды согласно публикациям Cordis. Свяжитесь с нами для подтверждения текущей доступности.
Показано 84 из 84 конфигураций
Size matrix and REF codes from the official Cordis SELUTION SLR brochure (100640237, 05.2024). Guide catheter compatibility: ≥ 5 Fr for 1.50 – 3.75 mm balloon diameters, ≥ 6 Fr for 4.00 – 5.00 mm.
Загрузки и документация
Инструкция по применению (IFU), технические спецификации и клиническая литература для SELUTION SLR PTCA Drug Eluting Balloon доступны по запросу у нашей клинической команды.
Запросить документациюЧасто задаваемые вопросы
- How long does the SELUTION SLR provide drug release?
- It is designed to deliver sustained limus release for up to 90 days.
- What is the benefit of the phospholipid coating?
- The coating facilitates drug uptake and retention in the tissue while minimizing drug loss during the procedure.
- What is the SELUTION DeNovo Study?
- According to Cordis, it is a prospective, randomized, multi-center, international, single-blind clinical trial comparing the SELUTION SLR DEB strategy versus a drug-eluting stent (DES) strategy in 3,326 patients, designed to evaluate non-inferiority at 1 year and possible superiority at 5 years, with target vessel failure at 1 and 5 years as the primary endpoints.
- Does SELUTION SLR have any special regulatory designations?
- Cordis reports that SELUTION SLR DEB was the first drug-eluting balloon to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA).
- How can our hospital order SELUTION SLR PTCA Drug Eluting Balloon in Azerbaijan?
- Contact Azmed Devices at info@azmeddevices.com. We provide manufacturer documentation, registration status and tender support, and coordinate supply directly with Cordis.
