US Medical Innovations (USMI), a biomedical and life science subsidiary of US Patent Innovations, has secured the US Food and Drug Administration (FDA) 510(k) approval for its Canady Plasma Smart XL-1000 Electrosurgical Generator (CPSXEG) with accessories.

The biomedical firm said that its CPSXEG has been designed to combine a high frequency voltage with electrically enhanced plasma gas (Argon) to produce a plasma gas stream.

Also, the system offers plasma gas stream in various modes including Canady Hybrid Plasma, Argon Plasma, along with standard cutting and coagulation modes.

USMI CEO and USPI companies chairman Jerome Canady said: “The Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is the next generation of Electrosurgical Generators. USMI is the first to transform an electrosurgical generator from Analog to Smart technology.

“The new generator is integrated with USMI’s patented Canady Hybrid Plasma (CHP) technology that is used to simultaneously cut, coagulate, and ablate biological tissue during surgery.”

GIMMS was developed by USMI’s US engineering team

USMI said that its CPSXEG is the first SMART electrosurgical generator in the world to have its own operating system, the Graphical Integrated Management Surgical System (GIMSS).

GIMSS includes pre-loaded surgical apps, data collection, built-in safety features and can be integrated with other surgical devices in the operating room.

The system has been designed to have a 12.1inch diagonal smart pad colour monitor touch screen, keypad, quick start application, tutorial screen, pre-surgical power settings for 400 physicians.

Users can select a specific surgical application from the list that includes general surgery, robotics, orthopaedics, endoscopy, gynaecology, transplantation, plastic and cosmetic surgery, trauma, cardiology, urology, surgical oncology, and paediatrics, through the APP screen

The device displays the physician name, device recognition and safety features, power in watts, gas flow rate, gas volume, and energy mode on its monitor, once it is activated.

Furthermore, CPSXEG is capable of downloading secure procedural data into the electronic medical record of the patient.

Canady added: “Unlike traditional plasma coagulation and standard electrosurgical devices, CHP technology creates a plasma gas energy beam that cuts and coagulates to a minimal invasive depth as low as 0.1 mm while maintaining a tissue temperature of approximately 98°F (37°C) or less.

“The beam can coagulate blood vessels up to 4mm. CPSXEG via GIMSS can provide a simple solution to a complex Operating Room (OR) when integrated with the Canady SMART OR Stealth Integration System including surgical devices for a variety of surgical applications.”