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The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.

The VivaRing™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The VivaRing M Microwave Ablation Probe consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.

The VivaTip™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.

The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.

The VivaTherm™ Temperature Measurement System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM).

The Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. The electrode comes with a connector that can be attached to a standard RF electrosurgical generator to assist in deployment of the curved microwave antenna into tissue. Once the curved antenna is fully deployed, the RF connector can be removed and the remaining microwave cable is connected to the Vivant VivaWave™ Microwave Generator. The microwave energy is then transmitted to the curved antenna which heats the tissue within and around the antenna.

The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.

The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.

The VivaWave™ Microwave System is intended for coagulation of soft tissue

The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector. The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic. The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly. The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.