HITIT MEDICAL

 

Hyperthermic Perfusion System

Performer® HT is the most advanced System for Hyperthermic Intraperitoneal and Intrapleural Perfusion and Hyperthermic Isolated Limb and Organ Perfusion.

By means of the assisted circulation of properly warmed solutions or blood (in case enriched with chemotherapeutic drugs), Perfusion Therapies cause localized and controlled hyperthermia of the involved anatomic region for a variable time period, according to the suitable therapeutic protocol.

Once catheters/drainages for the connection to the extracorporeal circuit have been placed inside the cavity (as well as the probes for temperature monitoring), the System allows to perform intraperitoneal or intrapleural perfusion using both “open” and “closed” technique.

 

Main Therapeutic Indications

1.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the combined surgical-medical treatment of i) primary peritoneal malignancies due to pseudomyxoma peritonei, malignant peritoneal mesothelioma, desmoplastic round small cell tumor, and ii) secondary peritoneal carcinomatosis due to colorectal, appendiceal, gastric, intestinal and ovarian cancers, by locoregional infusion of chemotherapy drugs, after cytoreduction surgery.

 

2.Hyperthermic Intrathoracic Chemotherapy (HITHOC) for the combined surgical-medical treatment of i) primary pleural malignancies due to malignant pleural mesothelioma, and ii) secondary pleural malignancies due to thoraco-mediastinic tumors, by locoregional infusion of chemotherapy drugs, after cytoreduction surgery.

 

3.Hyperthermic Isolated Limb Perfusion (ILP) for the combined surgical-medical treatment of i) malignant melanoma with in-transit metastases (Stage IIIA according to the MD Anderson Cancer Center staging system ), ii) malignant melanoma with in-transit metastases to regional lymph nodes (Stage IIIB), iii)malignant melanoma with in-transit metastases and to regional lymph nodes (Stage IIIAB), iv) not resectable primary sarcoma of the soft tissues.

 

4.Hyperthermic Isolated Liver Perfusion (ILIP) and Isolated Lung Perfusion (ILUP) for the oncological treatment of i) secondary multiple metastasis to the liver, from malignant gastrointestinal and ovarian tumors, and ii) secondary multiple metastasis to the lung, from malignant thoraco-mediastinic tumors.

 

Features

Heating and Temperature Monitoring

The high-efficiency heater is designed in order to reproduce a suitable heating trend, with the aim to minimize thermal shock on Patient’s tissues, assuring at the same time the gradual and even thermal conditioning of the perfused region.

• Available temperature range: from 28 to 46°C for intraperitoneal and intrapleural perfusion, from 28 to 45°C for isolated limb and organ perfusion;

• Up to 8 probes available for temperature monitoring in the Patient and along the extracorporeal circuit

• Real-time graphic display of the signals from all temperature probes

 

Flow Rate Adjustment

Flow rates up to 2000 ml/min simplify and improve even heat distribution during intraperitoneal and intrapleural perfusion.

 

Volumes Management

The System runs automatically the circuit priming phase and controls the fluid dynamic balancing with the Patient during the treatment; the easiness of the management always allows the user to supervise and modify quickly all the key parameters of the procedure.

 

Pressures Monitoring

Up to 6 sensors available for circuit’s pressure monitoring, always assuring the highest attainable safety level for the Patient and the OR staff.

 

User interface

The dynamic and “user-friendly” interface of the Performer® HT System allows easier and faster learning of all treatment available functions. Automatic procedures for treatment recovery and the “Online help” screens help the user to cope with any situation promptly, effectively and safely.

 

By-pass function

By diverting liquid path during the Hyperthermic Intraperitoneal or Intrapleural Perfusion, the By-pass automatic special function allows the user to exclude temporarily the Patient from the circulation, keeping at the same time both solution recirculation and warming at the preset temperature.

 

Safety

Performer® HT, CE marked and produced in compliance with the essential requirements of the Medical Device Directive 93/42/EEC, is a System designed and developed according to the defined intended use - Hyperthermic Perfusion - and the most updated safety Standards, with the aim to guarantee and preserve the safety of Patients and OR staff throughout the treatment.

 

Traceability and Data Recording

As regards every single procedure, the System stores all the information about personal data, treatment parameters and occurrences; by means of USB stick or Compact Flash Memory Card, the easiness of data management allows the user to create specific and detailed database.