Kronos Electrocautery Device
Single Pass
FDA Clearance Information
FDA-Cleared Indications
- Used to achieve hemostasis through coagulation in liver soft tissue.
- Used to achieve hemostasis through coagulation in kidney soft tissue.
- Used to achieve hemostasis through coagulation in lung soft tissue.
Clinical Applications
- Coagulation of a biopsy tract or tissue site in the liver to help control bleeding.
- Coagulation of a biopsy tract or tissue site in the kidney to help control bleeding.
- Coagulation of a biopsy tract or tissue site in the lung to help control bleeding.
- Hemostatic treatment of targeted liver, kidney, or lung soft tissue during a procedure when coagulation is clinically appropriate.
Practical Considerations
- The device is intended for soft-tissue coagulation in the liver, kidney, and lung; use outside these labeled tissues is not established by the FDA indication.
- The operator should confirm the device configuration, electrode or probe size, energy settings, and compatibility with the generator before use.
- Electrocautery requires careful control of energy delivery to limit unintended thermal injury, including injury to adjacent organs, vessels, airways, or collecting systems.
- MRI safety depends on the specific device configuration and labeling. Do not bring or use the device in the MRI environment unless the manufacturer provides applicable MR Safety information.
- Potential contraindications and precautions include inability to safely access the target tissue, uncorrected bleeding risk, active infection at the access site, or conditions in which thermal injury would create unacceptable risk.
Frequently Asked Questions
What problem is SinglePass Kronos trying to solve?
Post-biopsy bleeding risk and the downstream need for prolonged observation, repeat imaging, or intervention; it’s intended to provide tract hemostasis via electrocautery.
What tissues/organs are in the FDA indication?
Liver, kidney, and lung soft tissue (per FDA indications for use).
Is this a vascular closure device?
No—this is a biopsy tract electrocautery/hemostasis tool (tract management after coaxial biopsy).
What’s the best available clinical evidence right now?
Two small case-series publications (kidney and liver biopsies), each n=5, reporting no post-procedure bleeding on imaging and no complications through 30 days.
Does it definitively reduce admissions/length of stay?
Not definitively from controlled data. The concept and post-market evaluation target observation time and workflow, but published evidence is not yet comparative
What are the major unanswered questions?
Comparative effectiveness vs standard tract management (gelfoam/plugging/manual pressure), real-world complication rates at scale, and performance in higher-risk anticoagulated/coagulopathic populations.