Abbott Amplatzer PFO Occluder

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Specifications

  1. Device Design:
    • Structure: Double-disc configuration connected by a central waist.
    • Material: Made from nitinol, a nickel-titanium alloy known for flexibility and biocompatibility.
    • Fabric Lining: Polyester material within the discs to promote tissue growth and ensure complete closure of the PFO.
  2. Sizes:
    • Available in various sizes ranging from 18 mm to 35 mm to fit different PFO anatomies.
  3. Delivery System:
    • Catheter-based delivery for minimally invasive placement.
    • Flexible delivery sheath compatible with standard PFO closure techniques.
  4. Anchoring Mechanism:
    • The discs are designed to anchor securely on either side of the septum, minimizing the risk of migration.
  5. MRI Compatibility:
    • MRI Conditional: Safe for magnetic resonance imaging under specified conditions.

Description

Abbott Amplatzer PFO Occluder

Key Features

  1. Minimally Invasive Procedure:
    • Inserted via a catheter through the femoral vein, avoiding open-heart surgery.
    • Short recovery time for the patient.
  2. Self-Expanding Nitinol Frame:
    • Ensures optimal positioning and adaptation to the patient’s anatomy.
  3. Promotes Tissue Healing:
    • The polyester fabric encourages endothelialization, sealing the PFO effectively over time.
  4. High Success Rate:
    • Proven to significantly reduce the risk of recurrent stroke in patients with cryptogenic stroke linked to PFO.
  5. Long-Term Solution:
    • Designed for permanent implantation, providing lifelong closure of the PFO.

Indications

  • Stroke Prevention:
    • For patients with a history of cryptogenic stroke where PFO is suspected as a contributing factor.
  • Migraine Relief (Investigational Use):
    • Emerging research suggests potential benefits in reducing migraines in certain patients with PFO.
  • Divers or High-Risk Professions:
    • To reduce decompression illness risks in professional divers or pilots with PFO.

Procedure Overview

  1. Pre-Procedure:
    • Patients undergo imaging tests like echocardiography to confirm the presence and size of the PFO.
  2. Placement:
    • A catheter delivers the occluder through the femoral vein to the heart.
    • The device is positioned across the PFO and deployed, with discs anchoring securely on either side of the septum.
  3. Post-Procedure Care:
    • Short-term anticoagulation or antiplatelet therapy is prescribed to prevent clots while the device endothelializes.
    • Follow-up imaging to confirm proper placement and closure.

Clinical Benefits

  1. Reduces Stroke Risk:
    • Effectively prevents emboli from crossing the PFO and reaching the brain.
  2. Minimally Invasive:
    • Reduced risks and faster recovery compared to surgical options.
  3. Improved Quality of Life:
    • Offers peace of mind for patients at risk of recurrent stroke.
  4. Durability:
    • Designed for permanent implantation, ensuring long-term efficacy.

The Abbott Amplatzer PFO Occluder is a trusted solution for addressing PFO-related complications, offering patients a safe, minimally invasive, and effective method to reduce their stroke risk.

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