đź“‹ FDA Reference
varipulse catheter trupulse generator sterile interface cable ngen pump
Biosense Webster
Summary: The Varipulse Catheter Trupulse Generator is a medical device used for tumor ablation. It is primarily used by interventional radiologists and oncologists to treat tumors in various clinical settings.
FDA Clearance Information
Pathway
PMA
Number
P240006 ↗
Decision Date
January 2, 2026
Product Code
QZI
Device Class
Class 3
Evidence
0 studies
The Varipulse Catheter Trupulse Generator, manufactured by Biosense Webster, received FDA clearance under PMA P240006 on January 2, 2026. It is classified as a Class 3 medical device.
What It Is
The Varipulse Catheter Trupulse Generator is an advanced medical device designed for the ablation of tumors. It utilizes a catheter-based system to deliver precise energy pulses to target and destroy tumor tissues. The device includes a sterile interface cable and an ngen pump, which are integral to its operation, ensuring controlled and effective energy delivery.
Clinical Applications
This device is commonly used in interventional oncology for the treatment of solid tumors. It is particularly useful in minimally invasive procedures where precision is crucial, such as in liver or kidney tumor ablations. The device is typically employed in hospital settings, often in interventional radiology suites, and is used on adult patients who are candidates for tumor ablation therapy.
Indications for Use
The FDA indications note the addition of an alternate supplier for a component used in the device's interface cable. Clinically, this means the device is intended for use in tumor ablation procedures, providing a reliable option for clinicians treating patients with solid tumors.
Practical Considerations
Clinicians should be aware of the device's compatibility with existing ablation systems and ensure proper sizing of the catheter for the specific procedure. The sterile interface cable is crucial for maintaining sterility and effective energy transfer during procedures.
Frequently Asked Questions
What is the Varipulse Catheter Trupulse Generator used for?
It is used for the ablation of tumors, delivering precise energy to destroy tumor tissues.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for tumor ablation, with a focus on ensuring reliable component supply for its interface cable.
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.