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ultimum ev hemostasis introducer
St Jude Medical
Summary: The Ultimum EV Hemostasis Introducer is a medical device used to facilitate vascular access during endovascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K140327 ↗
Decision Date
March 11, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultimum EV Hemostasis Introducer was cleared through the FDA 510(k) pathway on March 11, 2014. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Ultimum EV Hemostasis Introducer is a specialized catheter introducer designed to provide hemostasis during vascular access procedures. It is used to introduce guidewires and catheters into the vascular system, minimizing blood loss and facilitating smoother procedures. The device is particularly useful in complex endovascular interventions where maintaining hemostasis is critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as angiography, stent placement, and embolization. It is particularly beneficial in settings where vascular access is challenging, such as in patients with compromised vascular anatomy or in hostile groin regions. The introducer is suitable for use in both hospital and outpatient settings, catering to adult patients undergoing endovascular interventions.
Indications for Use
The FDA indications suggest that the Ultimum EV Hemostasis Introducer is intended for use in procedures requiring vascular access and hemostasis. It is particularly indicated for patients undergoing endovascular interventions where maintaining hemostasis is crucial.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and catheters used in endovascular procedures. Clinicians should be trained in ultrasound-guided vascular access techniques to optimize the use of this device.
Related Literature
The linked study investigated the use of the superficial femoral artery (SFA) for vascular access in patients with hostile groin anatomy. It compared ultrasound-guided SFA puncture to traditional SFA cutdown, finding that ultrasound guidance was a feasible and safe alternative. However, the study was limited by its focus on a specific patient population and procedural context.
Frequently Asked Questions
What is the Ultimum EV Hemostasis Introducer used for?
It is used to facilitate vascular access and maintain hemostasis during endovascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in endovascular procedures requiring vascular access and hemostasis.
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.