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The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus InCore Rotational Core Biopsy System consists of a fully integrated control unit, sticking needle, cutting cannula and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications: General Surgery - Ablation of breast fibroadenoma . - Localization of breast lesions . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . Oncology - . Ablation of cancerous or malignant tissue - Ablation of benign tumors . - Palliative intervention .

The V2 Treatment System consists of a control unit that controls one single-use, disposable V2 ICE Probe. The system utilizes a cryogen as a cooling agent and a resistance heater for thawing. The V2 Console is a self-contained, mobile unit, which features an easy-to-use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allows users to select treatment modes and times and control the system and its cycles. The screen is mounted on the system and will tilt and swivel as needed. The Console operates off standard 120/240 VAC (60/50 Hz) power. The V2 ICE Probe is a single use, disposable probe designed for use with the V2 Treatment System. The primary components of the V2 ICE Probes consist of a surgical stainless steel probe with an electrical warming component and an integrated T-Type Thermocouple for internal temperature feedback. The V2 Probe temperature is internally and continuously monitored by the V2 Console.

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications: General Surgery - Ablation of breast fibroadenoma . - Localization of breast lesions . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . Oncology - Ablation of cancerous or malignant tissue . - Ablation of benign tumors ● - Palliative intervention

The Visica Treatment System consists of a control unit that controls one single-use, disposable (Visica Treatment Device or "cryoprobe"). The system utilizes incrt argon gas as a cooling agent and helium for thawing. The cystem unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent on the ts manitant to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications: General Surgery - . Ablation of breast fibroadenoma - Localization of breast lesions . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . Oncology - . Ablation of cancerous or malignant tissue - Ablation of benign tumors . - . Palliative intervention

The Visica Treatment System consists of a control unit that controls one single-use. disposable (Visica Treatment Device or "cryoprobe"). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent temperature probes to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Cassi II Rotational Core Biopsy System consists of a fully integrated control unit (Handle), Biopsy Needle Unit (comprised of a sticking needle and cutting cannula) and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.q., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Centrica II Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several qauge sizes and lengths.

The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.

The Sanarus Indica Marker System consists of a delivery device (applier), introducer cannula and non-absorbable tissue marker that is clearly visible on standard radiographs and ultrasound.

The Sanarus Visica™ Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications: General Surgery - Ablation of breast fibroadenoma - Localization of breast lesions Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology - Ablation of cancerous or malignant tissue - Ablation of benign tumors - Palliative intervention

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe (Visica™ Treatment Device). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. A remote foot-pedal can be used to start and stop the system. The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only to the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control two independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.