The company designed its technology to minimize exposure to surgical smoke for surgeons and care teams in an effort to reduce the risk of infection and long-term exposure toxicity. The devices also clear smoke from inside a patient’s abdomen during minimally invasive laparoscopic and/or robotic procedures, improving visibility for the surgeons.
The company points to increasing safety regulations as one driver of its business, saying 18 U.S. states require preventative measures in surgical procedures that create smoke, with legislation pending in four more states. That’s up from just one state in 2018, the company said.
Alesi calls its Ultravision system a “revolutionary medical device” that “produces a low-energy electrostatic charge that eliminates surgical smoke from the atmosphere as it is created by the cutting instrument.”
“The technology also benefits the patient as it can minimize the pressure, flow rate and volume of cold, dry carbon dioxide gas that a patient is exposed to during laparoscopic and robotic surgery,” the company says. “Excessive use of carbon dioxide, which is used to create a working space inside the abdomen, contributes to cardiovascular problems, complications in anesthesia, post-surgical pain, and longer recovery time for the patient.”
Alesi Surgical’s electrostatic precipitation smoke management technology
The company won FDA 510(k) clearance of its Ultravision2 system in October 2023 and 510(k) clearance of its IonPencil electrosurgical device in August 2024, allowing the Ultravision system to be used for open surgery as well as laparoscopic and robotic procedures.Alesi Surgical says IonPencil is a better way to manage surgical smoke in open surgery than suction-based smoke evacuators and electrosurgery smoke pencils.
“Surgeons have been vociferous in their reluctance to adopt current smoke pencils,” Alesi Surgical CEO Dominic Griffiths said in a statement. “We believe that offering them such a simple, effective, and ergonomic device will greatly improve compliance with the increasing legislation being introduced across the U.S.”
The Ultravision2 system includes a generator that interfaces directly with commercially available electrosurgical generators, serving as a passthrough for high-frequency (HF) energy electrosurgical instruments.
The Alesi Surgical Integrated Monopolar L-Hook (H/S) is used for soft tissue cutting and coagulation with smoke management during laparoscopic surgery only. However, the IonPencil — featuring a 69mm-long, PTFE-coated blade — combines HF energy cutting and coagulation of soft tissue with smoke management for all surgical procedures.
Both instruments use Ultravision’s electrostatic precipitation smoke management technology. That electrostatic precipitation comes from the company’s Ultravision Ionwand, which “creates negatively charged gas ions in the abdominal cavity, which move towards the positive patient tissuel,” according to Alesi’s website.
“As the ions move, they collide with water vapor and particular matter and draw them away from the surgical site,” the company continues. “Particles land, and the electrical charge flows back to the generator.”
The Ionwand has a tip made of annealed, implant-grade stainless steel and uses a dedicated, percutaneous 3mm trocar/catheter for a cable that delivers low energy from the generator to the patient for smoke management, Alesi said in FDA filings. The Ultravision2 system features automated Ionwand activation to clear the smoke when the electrosurgical tool is generating it.
Alesi says independent research has “demonstrated that Ultravision technology is 23 times better than alternative solutions at minimizing surgical smoke release into the operating room during laparoscopic surgery.”
“In addition, Ultravision’s unique mode of action captures and reduces the infectivity of aerosolised viruses,” the company continued. “The slimline, tubing-free, and silent IonPencil now brings the performance of the Ultravision technology to open surgery, helping to overcome the limitations that have hindered smoke management adoption.”
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