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fast-pass ace models 1212t 1222t 1216t 1226t
Pacesetter Systems
Summary: The Fast-Pass ACE models 1212t, 1222t, 1216t, and 1226t are inferior vena cava (IVC) filters used to prevent pulmonary embolism. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K900550 ↗
Decision Date
April 20, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Fast-Pass ACE models were cleared via the FDA 510(k) pathway on April 20, 1990. Manufactured by Pacesetter Systems, these devices are classified as Class III under product code DTB.
What It Is
The Fast-Pass ACE models are a series of inferior vena cava (IVC) filters designed to prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. These filters are typically inserted into the IVC via a catheter-based procedure and act as a mechanical barrier to large emboli. They are often used in patients who are at high risk for venous thromboembolism and cannot tolerate anticoagulation therapy.
Clinical Applications
IVC filters like the Fast-Pass ACE models are commonly used in emergency and surgical settings, particularly in patients with contraindications to anticoagulation. They are frequently employed by interventional radiologists and vascular surgeons in hospitals. Typical patient populations include those with deep vein thrombosis (DVT), trauma patients, or those undergoing major surgeries with a high risk of thromboembolic events.
Indications for Use
The FDA indications for these devices include prevention of recurrent pulmonary embolism in patients with DVT who cannot receive anticoagulation therapy. They are also indicated for patients who have experienced recurrent embolism despite anticoagulation.
Practical Considerations
These IVC filters are available in various sizes to accommodate different patient anatomies. They are compatible with standard catheter delivery systems and require fluoroscopic guidance for accurate placement. Clinicians should be aware of potential complications such as filter migration or perforation.
Frequently Asked Questions
What is Fast-Pass ACE used for?
Fast-Pass ACE models are used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use these devices.
What are the FDA-cleared indications?
The devices are indicated for preventing recurrent pulmonary embolism in patients with DVT who cannot undergo anticoagulation therapy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.