Author: Dominic Papandria, MD
Alesi Surgical received FDA approval for the Ultravision™ Visual Field Clearing System on 4 May 2020. Predicate systems by the same vendor were approved in Sept 2018 and in May 2015.
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The system utilizes electrostatic precipitation for smoke clearance and consists of:
- The Ultravision™ generator
- A compatible trocar – either 3.1 mm dedicated trocar
- Or a 5mm radially dilating trocar
- The Ionwand on which the smoke and particulate precipitate; it is connected to the Ultravision™ generator by a 250 cm cable
The system utilizes a reusable patient return adapter that connects the Ultravision™ generator to a standard electrosurgical unit, allowing both to utilize a common dispersive electrode (“grounding pad”). The system can be powered using a rechargeable battery or via AC power.
Optimal placement of the trocar is within 5 inches of the energy source producing smoke and particulates and with a direct line of sight to the operative field. Benefits of the use of this device include improved visual field, decreased need to vent insufflated gas to evacuate smoke and decreased need to clean laparoscope lens when soiled by particulate.
Animal studies: Simulated laparoscopy (50-100 min) were performed on porcine omentum using monopolar, bipolar and ultrasonic instruments
RCT: double-blinded, prospective trial (N=30) with six week follow-up (N=25) for patients receiving elective laparoscopic cholecystectomy. Primary endpoint was a clear visual field and secondary patient safety endpoints. Device found to be effective, without differences in secondary endpoints.
The FDA determined this device is substantially equivalent to a predicate devices: the Utravision™ Visual Clearing System (K170178) and Ultravision™ Visual Field Clearing System (K182053, DEN150022); reference devices: Ethicon Endopath Excel Bladeless Trocar with Stability Sleeve 5 – 12mm (K032676).
Although initially designed and marketed for use in laparoscopic general surgical, urologic and gynecologic procedures, the most recent FDA approval has added an indication for open abdominal procedures. It is not immediately apparent how the Ionwand would be effectively deployed for open procedures.
The device is not approved for use in pediatric procedures.
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Health Park, Cardiff
- Ansell J, Warren N, et al “Electrostatic precipitation is a novel way of maintaining visual field clarity during laparoscopic surgery: a prospective double-blind randomized controlled pilot study” Surg Endosc. 2014 Jul;28(7):2057-65. [PMID 24570011]
- Levine D, Petroski GF, et al “Electrostatic Precipitation in Low Pressure Laparoscopic Hysterectomy and Myomectomy” JSLS. Oct-Dec 2020;24(4):e2020.00051. [PMCID 7550014]
- Buggisch JR, Göhler D, et al “Experimental Model to Test Electrostatic Precipitation Technology in the COVID-19 Era: A Pilot Study” J Am Coll Surg. 2020 Dec; 231(6): 704–712. [PMCID 7470820]