OmniGuide Holdings Receives FDA Clearance for RevoLix™ HTL Hybrid Thulium Laser for the treatment of BPH and Stones
BILLERICA, Mass.–(BUSINESS WIRE)–OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix™ HTL a family of pulsed and continuous wave Thulium YAG lasers is the foundation of RevoLix Therapy for urology patients undergoing BPH and Stone Management procedures.
“The FDA’s clearance reflects our confidence in our unique RevoLix™ HTL therapy and our efforts into surgical laser innovation, setting new standards in patients’ safety,” said Dr. Samir Lamrini Global Director R&D LISA Institute for Digital Surgery “We believe strongly in our patient first innovation mindset, setting a path forward for urology patients to receive therapy for both BPH and Stone Management.”
“RevoLix™ HTL innovative Thulium YAG Continuous Wave and Pulse modes allow complete surgical customization of the Therapy parameters providing the surgeon with full control and confidence to address any Urological clinical procedure,” said Giorgio Brusa Executive Vice President Global Marketing OmniGuide Holdings “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. At the same time, patent pending HTL technology allows for stone clearance without overheating stone and urine medium.”
The FDA cleared Revolix™ HTL, LISA Laser GmbH a Division of OmniGuide Holdings Inc., through the 510(k) premarket clearance pathway. “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 Urologist here in the United States,” said Carlos Acosta Global Director of RA QA OmniGuide Holdings. “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.”
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About OmniGuide, Inc.
OmniGuide, Inc. is a patient safety-focused medical technology innovator, providing a portfolio of advanced energy surgical tools to benefit clinicians and their patients alike. The company’s technologies deliver energy in a precise and electrically silent manner, resulting in the preservation of healthy tissue.
OmniGuide Surgical, a leader in flexible fiber CO2 laser technology, offers a range of products designed to enhance surgical accuracy, access and control for minimally invasive surgery, laparoscopy and robotic-assisted surgery.
Domain Surgical, by OmniGuide, Inc., provides a patented ferromagnetic technology designed to provide safety and predictability in select surgical procedures that require cutting, coagulating and sealing of tissue.
LISA Laser Products GmbH, a leader in holmium and thulium laser technology, offers a wide range of products focused on improving clinical and patient outcomes in otolaryngology, neuro and urological surgical procedures.
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