{"id":44394,"date":"2022-05-26T19:02:01","date_gmt":"2022-05-26T17:02:01","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/omniguide-holdings-receives-fda-clearance-for-revolix-htl-hybrid-thulium-laser-for-the-treatment-of-bph-and-stones\/"},"modified":"2022-05-26T19:02:01","modified_gmt":"2022-05-26T17:02:01","slug":"omniguide-holdings-receives-fda-clearance-for-revolix-htl-hybrid-thulium-laser-for-the-treatment-of-bph-and-stones","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/omniguide-holdings-receives-fda-clearance-for-revolix-htl-hybrid-thulium-laser-for-the-treatment-of-bph-and-stones\/","title":{"rendered":"OmniGuide Holdings Receives FDA Clearance for RevoLix\u2122 HTL Hybrid Thulium Laser for the treatment of BPH and Stones"},"content":{"rendered":"
\n

BILLERICA, Mass.–(BUSINESS WIRE)–OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix\u2122 HTL<\/b> 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.\n<\/p>\n

<\/a>
<\/a><\/p>\n

\n\u201c<\/b>The FDA’s clearance reflects our confidence in our unique RevoLix\u2122 HTL therapy and our efforts into surgical laser innovation, setting new standards in patients’ safety,\u201d said Dr. Samir Lamrini Global Director R&D LISA Institute for Digital Surgery \u201cWe believe strongly in our patient first innovation mindset, setting a path forward for urology patients to receive therapy for both BPH and Stone Management.\u201d\n<\/p>\n

\n\u201cRevoLix\u2122 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,\u201d said Giorgio Brusa Executive Vice President Global Marketing OmniGuide Holdings \u201cVirtually 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.\u201d\n<\/p>\n

\nThe FDA cleared Revolix\u2122 HTL, LISA Laser GmbH a Division of OmniGuide Holdings Inc., through the 510(k) premarket clearance pathway. \u201cWith over 600 peer reviewed clinical articles and 31 years of surgical Thulium laser research and development experience, RevoLix\u2122 and OmniGuide look forward to serving patients and their Urologist here in the United States,\u201d said Carlos Acosta Global Director of RA QA OmniGuide Holdings. \u201cWith 2,500 lasers and over 200,000 patients per year treated globally by LISA Thulium technology , the RevoLix\u2122 product family has demonstrated a long clinical history of patient safety and low patient complication rate.\u201d\n<\/p>\n

\nFor information contact Maria DeSisto customerservice@omni-guide.com<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nOmniGuide Holdings
\n
Maria DeSisto customerservice@omni-guide.com<\/a>\n<\/p>\n

\n\u00a0\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

BILLERICA, Mass.–(BUSINESS WIRE)–OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix\u2122 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. \u201cThe FDA’s clearance reflects our confidence in our unique RevoLix\u2122 HTL therapy and our efforts … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-44394","6":"format-standard","7":"category-industry"},"yoast_head":"\nOmniGuide Holdings Receives FDA Clearance for RevoLix\u2122 HTL Hybrid Thulium Laser for the treatment of BPH and Stones - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/omniguide-holdings-receives-fda-clearance-for-revolix-htl-hybrid-thulium-laser-for-the-treatment-of-bph-and-stones\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OmniGuide Holdings Receives FDA Clearance for RevoLix\u2122 HTL Hybrid Thulium Laser for the treatment of BPH and Stones - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BILLERICA, Mass.–(BUSINESS WIRE)–OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix\u2122 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. \u201cThe FDA’s clearance reflects our confidence in our unique RevoLix\u2122 HTL therapy and our efforts ... 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