For US healthcare professionalsImportant Safety InformationReport a product issue(404) 594-4280

Product

The Focused Cryotherapy System

The Focused Cryotherapy System is an FDA 510(k) cleared cryoablation platform combining an argon-powered console, temperature-guided software, and a disposable dual-mode probe for controlled energy delivery.

PROBE

Directional Cryoprobe

Single-use, sterile, 20 cm × 2.1 mm. Circumferential or directional isotherms from the same probe, with real-time temperature feedback.

Probe
CONSOLE

Console

Runs up to four probes at a time from one 24" touchscreen, with an alarm system and a redundant control system.

Console and software
SOFTWARE

Temperature-guided software

Mode selection and live temperature for every probe, with optional CT import and planning.

Software
Directional Cryoprobe handle with the blue cold-side indicator strip
Blue strip indicates the cold side for directional ablation. Ice will form on this side.

Directional Cryoprobe

One probe. Two modes.

A handheld, single-use, disposable cryosurgical instrument that provides real-time temperature feedback, as well as circumferential or directional isotherms, depending on user inputs to the console.

  • Dimensions20 cm length (needle only) · 2.1 mm diameter
  • ModesCircumferential (360°) or directional (~180°), selected at the console
  • FeedbackThermocouples on the probe; temperature displayed in real time
  • PlacementTrocar needle tip · laser-etched insertion depth markings · handle color-coded to indicate directionality
  • Connection~10 ft whip tubing to a single proximal gas and electrical connector
  • SuppliedSterile (ethylene oxide), single use · MR Unsafe

Energy delivery

Select the mode for each probe.

The operator can switch between modes at any time while maintaining visibility into the probe temperature.

CIRCUMFERENTIAL · 360°10 mm

Circumferential freeze · 360°

A continuous freeze at 100% duty cycle by default to generate a 360° ablation zone around the probe. The duty cycle is configurable by the operator.

DIRECTIONAL · ~180°COLD SIDE10 mm

Directional freeze · ~180°

A built-in, pre-programmed directional protocol to generate an approximately 180° ablation zone on the cold side of the probe.

Active thaw

Heat is generated by the probe to thaw an ablation zone.

Passive thaw

No heat is generated by the probe.

Stick

An optional 30-second freeze to hold a placed probe in position during CT scans.

Diagrams drawn to scale from the laboratory isotherm data in the device labeling. In vivo performance varies. See performance data.

Focused Cryotherapy System software, Perform screen with four probes connected: channel 1 shows the mode menu and temperature history, channels 2 to 4 show probe ready, with axial, sagittal, coronal and 3D CT views on the right
Perform screen with four probes connected. CT views show a test phantom.

Console and Software

Setup. Plan. Perform.

Run up to four probes at a time, each on its own channel with its own mode and live temperature.

  • SetupOptional. Import the patient’s CT series.
  • PlanOptional. Review CT views and probe placement. Every probe passes the built-in Cryoprobe Test before use.
  • PerformChoose a mode for each probe and watch live temperature and history per channel.
  • CloseoutExport probe temperature plots and CT screenshots.

Setup, Plan, and Perform were evaluated in a simulated-use human factors study with 15 interventional radiologists and 15 CT technologists.

See the system in person.

Request a demonstration, labeling, or a conversation with our team.

Request a demonstrationContact us