Genel Ürün Özellikleri
| Şartname | Detay / Değer |
| Ürün Adı | Genişletici İlaç PTA Balon Kateteri (Gerçek platformunuza bağlı olarak Paklitaksel veya Sirolimus kaplamalı) |
| Amaçlanan Kullanım | Restenozisi azaltmak için periferik arterlerde (örneğin femoral, popliteal, tibial) perkütan transluminal anjiyoplasti (PTA) |
| Balon Malzemesi | İlaç kaplamalı Yarı/Uygun Olmayan Polimer (Naylon, Pebax) |
| İlaç Kaplama | Paklitaksel veya alternatif antiproliferatif ajan (x µg/mm²) |
| Nominal Enflasyon Baskısı | ~6–10 atm (çapa bağlı) |
| Nominal Patlama Basıncı (RBP) | ~12–16 atm (balonun büyüklüğüne bağlı olarak) |
| Kateter Şaft Uzunluğu | Genellikle 80–150 cm (ürün hattınıza göre ayarlayın) |
| Kılavuz Tel Uyumluluğu | 0,018” veya 0,035” (genellikle çevresel balonlar için—gerçek tasarımı doğrulayın) |
| Kaplama Serbest Bırakma | Şişirme sırasında hızlı ilaç salınımı (~30–60 saniye önerilen şişirme süresi) |
| Kısırlık | Steril (Etilen Oksit) |
| Tek Kullanımlık | Evet |
| Raf ömrü | Kapalı ambalajda 15–25 °C'de saklanırsa 2–3 yıl |
| Klinik Endikasyonlar | PAD (periferik arter hastalığı), femoropopliteal lezyonlar, diz altı hastalığı, periferik arterlerde stent içi restenoz |
| Kontrendikasyonlar | Önce aterektomi gerektiren yüksek oranda kalsifiye lezyonlar, ilaç kaplamasına karşı alerjik reaksiyon, ciddi şekilde kıvrımlı veya tıkalı damarlar |
Çap Aralığı 1,5–6,0 mm (Daha küçük damarlar, BTK veya orta femoral)
| Balon Çapı (mm) | Balon Uzunluğu (mm) | Nominal Basınç (atm) | RBP (atm) | İlaç Yükü (μg) | Ürün Kodu |
| 1.5 | 20 | 6 | 12 | ~200 | EXD-PTA-1.5x20 |
| 1.5 | 40 | 6 | 12 | ~400 | EXD-PTA-1.5x40 |
| 2.0 | 40 | 7 | 14 | ~600 | EXD-PTA-2.0x40 |
| 2.0 | 60 | 7 | 14 | ~900 | EXD-PTA-2.0x60 |
| 2.5 | 80 | 8 | 14 | ~1200 | EXD-PTA-2.5x80 |
| 3.0 | 80 | 8 | 14 | ~1500 | EXD-PTA-3.0x80 |
| 3.0 | 100 | 8 | 14 | ~1900 | EXD-PTA-3.0x100 |
| 3.5 | 100 | 8 | 14 | ~2200 | EXD-PTA-3,5x100 |
| 4.0 | 100 | 9 | 16 | ~2500 | EXD-PTA-4.0x100 |
| 4.0 | 120 | 9 | 16 | ~3000 | EXD-PTA-4.0x120 |
| 4.5 | 120 | 9 | 16 | ~3400 | EXD-PTA-4.5x120 |
| 5.0 | 80 | 9 | 16 | ~2000 | EXD-PTA-5.0x80 |
| 5.0 | 120 | 9 | 16 | ~3000 | EXD-PTA-5.0x120 |
| 6.0 | 80 | 10 | 16 | ~2200 | EXD-PTA-6.0x80 |
| 6.0 | 120 | 10 | 16 | ~3300 | EXD-PTA-6.0x120 |
Çap Aralığı 7,0–12,0 mm (Daha büyük femoral/popliteal veya iliak arterler için)
| Balon Çapı (mm) | Balon Uzunluğu (mm) | Nominal Basınç (atm) | RBP (atm) | İlaç Yükü (μg) | Ürün Kodu |
| 7.0 | 60 | 8 | 14 | ~2000 | EXD-PTA-7.0x60 |
| 7.0 | 80 | 8 | 14 | ~2600 | EXD-PTA-7.0x80 |
| 7.0 | 120 | 9 | 16 | ~3900 | EXD-PTA-7.0x120 |
| 8.0 | 80 | 9 | 16 | ~3000 | EXD-PTA-8.0x80 |
| 8.0 | 120 | 9 | 16 | ~4500 | EXD-PTA-8.0x120 |
| 9.0 | 80 | 9 | 16 | ~3400 | EXD-PTA-9.0x80 |
| 9.0 | 120 | 9 | 16 | ~5100 | EXD-PTA-9.0x120 |
| 10.0 | 80 | 10 | 16 | ~3800 | EXD-PTA-10.0x80 |
| 10.0 | 120 | 10 | 16 | ~5700 | EXD-PTA-10.0x120 |
| 12.0 | 80 | 10 | 16 | ~4600 | EXD-PTA-12.0x80 |
| 12.0 | 120 | 10 | 16 | ~6900 | EXD-PTA-12.0x120 |
Elevating Angioplasty with Precision and Efficacy
•Balloon Material: Durable and flexible for precise navigation and deployment.
•Compatibility: Usable with standard catheter systems.
•Size Range: Available in various sizes to accommodate different vascular diameters.
Choose for Optimal Drug Delivery
•Deployment: Rapid and controlled balloon inflation and deflation.
•Drug Type: Paclitaxel Incorporates anti-proliferative drugs to prevent restenosis.
•Drug Coating: Homogeneous drug distribution for consistent delivery.
Innovation Meets Vascular Treatment
•Highly compliant balloon material ensures optimal contact with the vessel wall for effective drug delivery.
•Therapeutic window achieved after 30 seconds inflation time.
•Rapid drug release and absorption kinetics ensure targeted therapeutic effects,assuring physicians of sustained results.
Safety and Effectiveness of the Novel TemREN Atherectomy System Combined Use With Extender Drug-Eluting Balloon in Lower Extremity Arteries
Results
For the primary analysis, the rate of lesion technical success was 97.0%, meeting the prospectively established target performance goal of 86%. After postatherectomy adjunctive therapy, residual stenosis was 30% for 100% of lesions means final diameter stenosis, 10.9%.
Early and midterm results of the retrograde transpopliteal approach as the first-line treatment for total occlusions of iliofemoral arteries.
Results
Technical success, defined as restored patency with no stenosis greater than 30%, was achieved in (92.9%) of patients. A patient who was a heavy smoker showed acute symptoms of claudication due to 80% stenosis of the iliac stent 20 days after discharge and was treated with balloon angioplasty.
•3.0-3.5ug / mm2 drug dosage
•<2mm particles
•Contrast media as a drug carrier
•Minimum drug release during delivery
•Available in Non-Compliant version
•<90% drug transfer to the target lession
•Quick deflation time
•Excellent pushability
Paclitaxel-Iopromid Coating
•Optimal Drug Delivery: Rapid paclitaxel release into the vessel wall upon balloon inflation aids in inhibiting neointimal hyperplasia.
•Stable Surface Layer: The specialized coating formulation resists delamination, ensuring controlled, uniform distribution of the antiproliferative agent.
Wide Balloon Diameter & Length Range
•Diameter: 1.5 mm–12.0 mm covers small distal arteries up to larger peripheral segments.
•Length: 20 mm–220 mm addresses both short, focal lesions and extensive diseased vessel segments—reducing procedural device exchanges.
Low-Profile Catheter & Multiple Guidewire Compatibility
•5F Shaft Design: Minimizes access-site trauma, beneficial for challenging anatomies or smaller access routes.
•Guidewire Options: Accommodates 0.014”, 0.018”, or 0.035” wires, offering flexibility in diverse peripheral vascular lesions
High Radiopacity for Accurate Placement
•Pt-Ir Markers: Ensures clear, real-time balloon positioning under fluoroscopy, facilitating precise lesion coverage and drug deposition.
Varied Catheter Lengths
•80, 90, 120, 135, 150 cm: Multiple workable lengths allow operators to select the ideal configuration for femoral, popliteal, tibial, or other target vessels.
