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vip plus percutaneous introducer
Medamicus
Summary: The VIP Plus Percutaneous Introducer is a medical device used for vascular access, particularly in challenging anatomical situations. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K944107 ↗
Decision Date
September 14, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The VIP Plus Percutaneous Introducer was cleared through the FDA 510(k) pathway on September 14, 1994. It is manufactured by Medamicus and classified as a Class II device.
What It Is
The VIP Plus Percutaneous Introducer is a device designed to facilitate vascular access, particularly in procedures requiring the insertion of catheters or other devices into the vascular system. It is used to create a percutaneous entry point into a blood vessel, typically using a needle and guidewire technique. This device is particularly useful in cases where traditional access points are challenging due to anatomical variations or previous surgical interventions.
Clinical Applications
The device is commonly used in interventional radiology and vascular surgery settings, especially for procedures involving embolization or the placement of coils. It is often employed in patients with complex vascular anatomy or in those who have undergone previous interventions that make standard access difficult. The introducer is used in hospitals and specialized clinics, primarily by clinicians trained in endovascular techniques.
Indications for Use
The FDA indications suggest that the device is intended for use in procedures requiring vascular access, particularly in situations where standard access is not feasible. This includes patients with challenging vascular anatomy or those requiring specific endovascular interventions.
Practical Considerations
The VIP Plus Percutaneous Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and catheters used in vascular interventions. Clinicians should be familiar with ultrasound guidance techniques to optimize insertion success and minimize complications.
Related Literature
The linked study evaluated the use of the ipsilateral superficial femoral artery (SFA) for vascular access in patients with a hostile groin, comparing ultrasound-guided puncture to traditional cutdown methods. The study found that ultrasound-guided SFA access was feasible and safe, offering a viable alternative to traditional methods. However, the study's limitations include a specific patient population and procedural context, which may not be generalizable to all clinical settings.
Frequently Asked Questions
What is the VIP Plus Percutaneous Introducer used for?
It is used for gaining vascular access in procedures where traditional access is challenging, such as in embolization or coil placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients with challenging anatomy or those requiring specific endovascular procedures.
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.