RevoLix HTL is optimised to treat BPH via tissue vaporisation (ThuVAP), vaporesection (ThuVARP), enucleation (ThuLEP), and vapoenucleation (ThuVEP)
OmniGuide Holdings receives FDA clearance for its RevoLix Hybrid Thulium Laser treatment device. (Credit: Business Wire/ OmniGuide Holdings, Inc.)
Medical device company OmniGuide Holdings has received the US Food and Drug Administration (FDA) clearance for its RevoLix HTL Hybrid Thulium Laser treatment device.
RevoLix HTL, a range of pulsed and continuous wave Thulium YAG lasers, is the foundation of RevoLix Therapy for urology patients undergoing BPH and Stone Management procedures.
RevoLix Thulium Lasers are optimised to effectively treat BPH via tissue vaporisation (ThuVAP), vaporesection (ThuVARP), enucleation (ThuLEP), and vapoenucleation (ThuVEP).
The device causes minimal tissue injury to effectively treat haemostasis without compromising surrounding tissues with excess heat.
Revolix HTL, a division of OmniGuide Holdings, was cleared by the FDA under the 510(k) premarket clearance procedure.
OmniGuide Holdings global marketing executive vice president Giorgio Brusa said: “RevoLix HTL innovative Thulium YAG Continuous Wave and Pulse modes allow complete surgical customisation of the Therapy parameters providing the surgeon with full control and confidence to address any Urological clinical procedure.
“Virtually no stone retropulsion and superior stone dusting compared to the gold standard Holmium YAG decreases OR time and may lead to improved patient outcomes.”
Brusa added: “At the same time, patent-pending HTL technology allows for stone clearance without overheating stone and urine medium.”
OmniGuide Holdings RA QA global director Carlos Acosta said: “With over 600 peer-reviewed clinical articles and 31 years of surgical Thulium laser research and development experience, RevoLix and OmniGuide look forward to serving patients and their urologists here in the United States.
“With 2,500 lasers and over 200,000 patients per year treated globally by LISA Thulium technology, the RevoLix product family has demonstrated a long clinical history of patient safety and low patient complication rate.”
In October 2018, the company provided its BEACON Advanced Energy Laser System to Morristown Medical Center.