SELUTION SLR PTCA Drug Eluting BalloonMəhsul Kodu (REF): SC14-375020
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.
Bu səhifə kataloq kodunu (REF) sənədləşdirir SC14-375020 — SELUTION SLR PTCA Drug Eluting Balloon məhsulunun mövcud 84 konfiqurasiyasından biri. Baxın: tam SELUTION SLR PTCA Drug Eluting Balloon icmalı hər konfiqurasiya üçün.
Aşağıdakı məhsul kodu(ları) altında mövcuddur SC14-150010, SC14-150015, SC14-150020, SC14-150025, SC14-150030, SC14-150035, SC14-150040, SC14-200010 və daha 76 ədəd (aşağıdakı Sifariş Məlumatına baxın).
Ölçülər və Spesifikasiyalar
- 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
İstehsalçı: Cordis · İstinad mənbəyi: cordis.com
Dizayn və Texnologiya
Cordis tərəfindən dərc edilmiş texniki xüsusiyyətlər və diaqramlar.
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.
Məhsul Xüsusiyyətləri
Cordis tərəfindən dərc edilmiş dizayn xüsusiyyətləri.
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.
Məhsulun İdentifikasiyası və Spesifikasiyaları
Satınalma, qeydiyyat və tender sənədləşməsi üçün istinad identifikatorları.
| Məhsul Kodu | SC14-375020 |
|---|---|
| REF Nömrə(lər)i | 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 |
| İstehsalçı | Cordis |
| Brend | Cordis |
| Məhsul Ailəsi | Koroner Müdaxilələr |
| Ölkə üzrə Mövcudluq | Azərbaycan |
Klinik Tətbiqlər
SELUTION SLR PTCA Drug Eluting Balloon — Cordis tərəfindən istehsal olunan Koroner Müdaxilələr ailəsindəki bir ptca coronary drug eluting balloon-dır və bu sinifdən olan ptca coronary drug eluting balloon-ın göstəriş olduğu prosedurlarda intervension mütəxəssislər tərəfindən istifadə olunur. Anatomik və prosedur tələblərinə uyğun gəlmək üçün 84 konfiqurasiyada (kataloq kodları SC14-150010-dən SC14-500040-a qədər) təchiz olunur.
Tam istifadə göstərişləri, əks göstərişlər və istifadə təlimatı (IFU) üçün klinik komandamız vasitəsilə rəsmi Cordis sənədlərini tələb edin. Azmed Devices SELUTION SLR PTCA Drug Eluting Balloon məhsulunu Azərbaycan boyunca xəstəxana və klinikalara təchiz edir.
Sifariş Məlumatı
Cordis tərəfindən dərc edilmiş kataloq istinad kodları. Cari mövcudluğu təsdiqləmək üçün bizimlə əlaqə saxlayın.
84 konfiqurasiyadan 84 göstərilir
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.
Yükləmələr və Sənədlər
SELUTION SLR PTCA Drug Eluting Balloon üçün istifadə təlimatı (IFU), texniki məlumat vərəqələri və klinik ədəbiyyat klinik komandamızdan tələb əsasında əldə edilə bilər.
Sənədləri Tələb EdinTez-tez Verilən Suallar
- 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.
