FDA MedTech Surgery

Olympus to distribute Alesi Surgical’s smoke control system

Olympus announced today that it has entered into an exclusive agreement with UK-based Alesi Surgical to distribute that company’s 510(k)-cleared Ultravision surgical smoke control system in the U.S.

Surgical smoke is a gaseous byproduct of tissue treated with electrical surgical devices, which are used for cautery, cutting and ablation, among other uses. If not properly managed, surgical smoke can be hazardous to the health of people working within the surgical suite.

Ultravision has FDA clearance for use in laparoscopic and open surgery. It is designed to suppress the aerosolization of surgical smoke and mist using electrostatic precipitation and to address three challenges in managing surgical smoke:

  • In laparoscopic surgery, Ultravision has been independently shown to remove particulates as small as 0.007µm — smaller than any known virus — from the atmosphere, without the need for CO2 exchange, according to an Alesi Surgical verification report performed by Cardiff University. The system is designed to prevent the need to vent surgical smoke into the perioperative environment.
  • By accelerating the natural sedimentation of surgical smoke, Ultravision provides a continuously clear visual field during laparoscopic surgery, according to Alesi, helping the surgical team operate accurately and efficiently.
  • Because it is designed to clear the visual field without the need to release smoke from within the abdominal cavity, Ultravision minimizes the amount of cold, dry CO2 that a patient is exposed to during the procedure.

“Healthcare professionals are rightly concerned about risks posed by bioaerosols, especially during the pandemic,” said Olympus chief medical officer Dr. Ross Segan in a news release. “However, we must find safe ways to continue performing surgical procedures using minimally invasive techniques because of the significant clinical benefits this type of surgery offers patients. With its unique and highly characterized mode of action, Ultravision offers an innovative means to control bioaerosols during laparoscopic surgery.”

“Given the immense resources and expertise of Olympus, this exciting partnership will greatly accelerate the ability of U.S. hospitals to access Ultravision and provide its benefits to staff and patients,” added Alesi Surgical CEO Dominic Griffiths.


Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/qzitiEVHxhY/)