Avenda Health Treatment System

The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 980nm.

The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 980nm.

The Avenda Health Treatment System ('Treatment System') is a thermal laser ablation system that causes coagulation necrosis of soft tissue. The Treatment System consists of the capital system Workstation and the single use Laser Applicator Kit. The Workstation contains core system hardware and software, provides the System's touchscreen user interface (UI), and serves as a 'hub' to facilitate the connectivity of other System components. The Laser Applicator Kit consists of two patient-contacting disposable components, the Laser Catheter, and the Thermal-Optical Probe ('TOP'), which facilitate delivery of laser energy and monitoring of temperature, respectively. The Treatment Monitoring Software, which operates on the Workstation, provides the UI for controlling the device, displays previously generated patient and treatment plan information for the procedure, and actively monitors the treatment progress during a procedure by displaying output from the TOP. The Treatment System is additionally used with an off-the-shelf accessory, the Tubing Set, which transports saline in a closed-loop system between the Workstation and Laser Catheter to provide cooling of the Laser Catheter. The Treatment System further includes an optional patient-contacting disposable accessory, the Multi-Channel Needle Guide ('MCG'), which may be used to attach an ultrasound probe to the Laser Catheter and TOP for enhanced visualization tracking, if desired.