| Şartname | Detay / Değer |
| Ürün Adı | Genişletici İlaç Salınımlı PTCA Balonu (Paklitaksel) |
| Amaçlanan Kullanım | Yeni veya restenotik lezyonlar için lokalize antiproliferatif tedavi sağlayan koroner anjiyoplasti (PTCA) |
| Kaplama / İlaç | Paklitaksel 3 µg/mm² (yaklaşık) |
| Balon Malzemesi | Yarı Uyumlu Naylon / Polyester Karışımı |
| Balon Tasarımı | Hızlı Değişim (RX), Tek Lümenli Kateter |
| Nominal Enflasyon Baskısı | 8–10 atm |
| Nominal Patlama Basıncı (RBP) | 14–16 atm |
| Balon Uyumluluğu | ~Nominalin 1 atm üzerindeki her basınçta 0,08 mm genleşme (tipik) |
| Kateter Şaft Uzunluğu | 140 cm (RX yapılandırması) |
| Kılavuz Tel Uyumluluğu | 0,014” |
| İlaç Salınım Mekanizması | Kontrollü paklitaksel salınımlı yüzey kaplaması |
| İlaç Salınım Süresi | İlaç transferi için ~30–60 saniye balon şişirme önerilir |
| Kısırlık | Steril (Etilen Oksit) |
| Tek Kullanımlık | Evet |
| Raf ömrü | 2–3 yıl (kaplamanın stabilitesine bağlı) |
| Depolama Sıcaklığı | 15–25 °C, nemden ve doğrudan güneş ışığından koruyun |
| Endikasyonlar | Koroner arter lezyon genişlemesi, stent içi restenoz, küçük damar hastalığı |
| Kontrendikasyonlar | Korunmasız sol ana, ciddi şekilde kalsifiye lezyonlar (hekimin kararına göre), bilinen paklitaksel alerjisi |
| Balon Çapı (mm) | Balon Uzunluğu (mm) | Nominal Basınç (atm) | RBP (atm) | Yaklaşık. Paklitaksel (µg) | Ürün Kodu |
| 1.50 | 6 | 8 | 14 | ~300 µg | EXD-PTCAB-15-06-PX |
| 1.50 | 10 | 8 | 14 | ~500 µg | EXD-PTCAB-15-10-PX |
| 1.50 | 15 | 8 | 14 | ~750 µg | EXD-PTCAB-15-15-PX |
| 2.00 | 6 | 8 | 14 | ~400 µg | EXD-PTCAB-20-06-PX |
| 2.00 | 10 | 8 | 14 | ~700 µg | EXD-PTCAB-20-10-PX |
| 2.00 | 15 | 8 | 14 | ~1000 µg | EXD-PTCAB-20-15-PX |
| 2.00 | 20 | 8 | 14 | ~1300 µg | EXD-PTCAB-20-20-PX |
| 2.25 | 10 | 8 | 14 | ~800 µg | EXD-PTCAB-22-10-PX |
| 2.25 | 15 | 8 | 14 | ~1200 µg | EXD-PTCAB-22-15-PX |
| 2.25 | 20 | 8 | 14 | ~1600 µg | EXD-PTCAB-22-20-PX |
| 2.25 | 25 | 8 | 14 | ~2000 µg | EXD-PTCAB-22-25-PX |
| 2.50 | 10 | 9 | 14 | ~900 µg | EXD-PTCAB-25-10-PX |
| 2.50 | 15 | 9 | 14 | ~1400 µg | EXD-PTCAB-25-15-PX |
| 2.50 | 20 | 9 | 14 | ~1800 µg | EXD-PTCAB-25-20-PX |
| 2.50 | 30 | 9 | 14 | ~2800 µg | EXD-PTCAB-25-30-PX |
| 2,75 | 15 | 9 | 15 | ~1600 µg | EXD-PTCAB-27-15-PX |
| 2,75 | 20 | 9 | 15 | ~2100 µg | EXD-PTCAB-27-20-PX |
| 2,75 | 30 | 9 | 15 | ~3100 µg | EXD-PTCAB-27-30-PX |
| 3.00 | 10 | 10 | 16 | ~1100 µg | EXD-PTCAB-30-10-PX |
| 3.00 | 15 | 10 | 16 | ~1600 µg | EXD-PTCAB-30-15-PX |
| 3.00 | 20 | 10 | 16 | ~2100 µg | EXD-PTCAB-30-20-PX |
| 3.00 | 30 | 10 | 16 | ~3100 µg | EXD-PTCAB-30-30-PX |
| 3.00 | 40 | 10 | 16 | ~4200 µg | EXD-PTCAB-30-40-PX |
| 3.50 | 15 | 10 | 16 | ~1900 µg | EXD-PTCAB-35-15-PX |
| 3.50 | 20 | 10 | 16 | ~2400 µg | EXD-PTCAB-35-20-PX |
| 3.50 | 30 | 10 | 16 | ~3600 µg | EXD-PTCAB-35-30-PX |
| 3.50 | 40 | 10 | 16 | ~4800 µg | EXD-PTCAB-35-40-PX |
| 4.00 | 10 | 10 | 16 | ~1500 µg | EXD-PTCAB-40-10-PX |
| 4.00 | 15 | 10 | 16 | ~2200 µg | EXD-PTCAB-40-15-PX |
| 4.00 | 20 | 10 | 16 | ~2800 µg | EXD-PTCAB-40-20-PX |
| 4.00 | 30 | 10 | 16 | ~4200 µg | EXD-PTCAB-40-30-PX |
| 4.00 | 40 | 10 | 16 | ~5600 µg | EXD-PTCAB-40-40-PX |
| 4.50 | 15 | 10 | 16 | ~2500 µg | EXD-PTCAB-45-15-PX |
| 4.50 | 20 | 10 | 16 | ~3100 µg | EXD-PTCAB-45-20-PX |
| 4.50 | 30 | 10 | 16 | ~4600 µg | EXD-PTCAB-45-30-PX |
| 4.50 | 40 | 10 | 16 | ~6000 µg | EXD-PTCAB-45-40-PX |
| 5.00 | 20 | 10 | 16 | ~3500 µg | EXD-PTCAB-50-20-PX |
| 5.00 | 30 | 10 | 16 | ~5200 µg | EXD-PTCAB-50-30-PX |
| 5.00 | 40 | 10 | 16 | ~7000 µg | EXD-PTCAB-50-40-PX |
Extender Drug Eluting PTCA Balloon Catheters
•Engineered with advanced drug-coating technology, ensuring uniform and controlled drug delivery to the vessel wall
•Optimally designed for precise lesion dilation while minimizing vessel wall trauma, providing therapeutic advantages in challenging scenarios
Precision Treatment, Exceptional Results
•Drug incorporated in hydrophilic coating
•Hydrophilic coating delivers Paclitaxel homogeneous to the vessel wall instantaneously upon contact
•No airborne particles at any time and no premature release of Paclitaxel
•Paclitaxel is only released when the balloon touches the vessel wall
Elevating PTCA to New Heights
•No longitudinal growth for controlled expansion, even at high pressures
•No balloon deformations up to rated burst pressure for precise stent apposition
•Rapidly and maximally absorbed by the vessel wall
•Minimized drug loss in bloodstream prior to inflation securing reliable drug dose delivery
•Load secured to achieve the therapeutic window within 30 seconds inflation time
•providing an extensive and safe working range
By choosing the Extender Drug-Eluting PTCA Balloon, healthcare professionals are not just choosing a device; they are choosing a solution that brings together the best in medical engineering and pharmacology to provide a comprehensive treatment option. With the Extender Balloon, patients are in good hands, and surgeons are equipped to deliver exceptional care.
EFFORTLESS DELIVERABILITY
By choosing the Extender Drug-Eluting PTCA Balloon, healthcare professionals are not just choosing a device; they are choosing a solution that brings together the best in medical engineering and pharmacology to provide a comprehensive treatment option. With the Extender Balloon, patients are in good hands, and surgeons are equipped to deliver exceptional care.
No procedural limitations
•No change in standard operating procedures and no handling required
•No pre-dilatation required: Lesion crossing does not influence drug delivery
•Multiple inflations will not lead to toxic levels
•Therapeutic window achieved after 30 seconds inflation time
•Flexibility and characteristics of a normal workhorse PTCA balloon
Highly compliant balloon material ensures optimal contact with the vessel wall for effective drug delivery.
Paclitaxel Drug Coating
•Localized Drug Delivery: The balloon’s 3.0–3.5 µg/mm² paclitaxel formulation aims to inhibit neointimal hyperplasia, reducing the risk of recurrent stenosis.
•Optimized Release Profile: Ensures adequate drug transfer upon inflation, without prolonged systemic exposure.
Balloon Dimensions and Range
•Balloon Diameters: 2.0 mm to 5.0 mm, covering small vessel and large coronary segment needs.
•Balloon Lengths: 10, 15, 17, 20, 26, and 30 mm, offering tailored lesion coverage based on vessel size and lesion extent.
Rapid Exchange (RX) Shaft Design
•Easy Wire Management: Facilitates quick guidewire exchanges and precise navigation in branch or distal lesions.
•Catheter Lengths: 120 cm and 150 cm, adapting to various patient anatomies or access routes (radial/femoral).
Radiopaque Markers
•RO Marker Bands: Enhance fluoroscopic visibility, aiding in accurate balloon positioning and monitoring during inflation.
Guidewire Compatibility
•0.014” Standard: Ensures broad usage with common PCI guidewires, promoting smooth device transitions.
