קטטר בלון PTCA משחרר תרופות Extender פקליטקסל

קטטר בלון PTCA משחרר תרופות Extender פקליטקסל

א מצופה פקליטקסל קטטר בלון כלילי מכוון הפחתת היצרות רזסטוזיס במהלך אנגיופלסטיה כלילית טרנסלומינלית דרך העור (PTCA), תוך הבטחת מתן יעיל של תרופות לדופן כלי הדם.

מֵידָע

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.



Proven efficacy in inhibiting restenosis, backed by robust clinical evidence and favorable outcomes

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 Diameters: 2.0 mm to 5.0 mm, covering small vessel ו 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.
  • Easy Wire Management: Facilitates quick guidewire exchanges and precise navigation in branch אוֹ דיסטלי lesions.
  • Catheter Lengths: 120 cm and 150 cm, adapting to various patient anatomies or access routes (radial/femoral).
  • RO Marker Bands: Enhance fluoroscopic visibility, aiding in accurate balloon positioning and monitoring during inflation.
  • 0.014” Standard: Ensures broad usage with common PCI guidewires, promoting smooth device transitions.
  • 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 Diameters: 2.0 mm to 5.0 mm, covering small vessel ו 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.
  • Easy Wire Management: Facilitates quick guidewire exchanges and precise navigation in branch אוֹ דיסטלי lesions.
  • Catheter Lengths: 120 cm and 150 cm, adapting to various patient anatomies or access routes (radial/femoral).
  • RO Marker Bands: Enhance fluoroscopic visibility, aiding in accurate balloon positioning and monitoring during inflation.
  • 0.014” Standard: Ensures broad usage with common PCI guidewires, promoting smooth device transitions.

מִפרָט פירוט / ערך
שם המוצר Extender Drug Eluting PTCA Balloon (Paclitaxel)
שימוש מיועד Coronary angioplasty (PTCA) for de novo or restenotic lesions, delivering localized antiproliferative therapy
Coating / Drug Paclitaxel 3 µg/mm² (approx.)
Balloon Material Semi-Compliant Nylon / Polyester Blend
Balloon Design Rapid-Exchange (RX), Single-Lumen Catheter
Nominal Inflation Pressure 8–10 atm
Rated Burst Pressure (RBP) 14–16 atm
Balloon Compliance ~0.08 mm expansion per 1 atm above nominal (typical)
Catheter Shaft Length 140 cm (RX configuration)
תאימות חוטי הנחיה 0.014”
Drug Release Mechanism Surface coating with controlled paclitaxel release
Drug Release Time ~30–60 seconds balloon inflation recommended for drug transfer
עֲקָרוּת סטרילי (אתילן אוקסיד)
לשימוש חד פעמי כֵּן
חיי מדף 2–3 years (depends on coating stability)
Storage Temperature 15–25 °C, protect from humidity and direct sunlight
אינדיקציות Coronary artery lesion dilation, in-stent restenosis, small vessel disease
התוויות נגד Unprotected left main, severely calcified lesions (per physician’s judgment), known paclitaxel allergy

Balloon Diameter (mm) Balloon Length (mm) Nominal Pressure (atm) RBP (atm) Approx. Paclitaxel (µg) קוד מוצר
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

מוצרים קשורים