LIVINGSTON, NJ--(Marketwired - November 04, 2015) - Milestone Scientific Inc.'s (NYSE MKT: MLSS) Epidural & Intra-Articular (IA) Subsidiary today announced that it has submitted initial results of the prospective, open label, clinical trial assessing the CompuFlo® technology in correctly identifying the epidural space during an epidural procedure in obese patients to a prestigious American pain management society in advance of this organization's annual meeting in 2016.
Success of the epidural technique depends upon the correct identification of the epidural space. The incidence of difficult epidural catheter placement and early failure is significantly more likely among the morbidly obese population. The increased amount of subcutaneous and epidural fat in the obese population can pose a significant challenge to successful epidural catheter placement.
After IRB approval and under United States Food and Drug Administration Investigations Device Exemption, patients were enrolled in a prospective controlled multi-center trial and were randomized to have the epidural space identified by either standard of care methods utilizing the loss of resistance technique or by utilizing real-time pressure measurement at the epidural needle tip via the CompuFlo® Epidural Instrument. A blinded independent observer evaluated correct identification of the epidural space defined as correct spread of dye demonstrated by fluoroscopy.
Leonard Osser, Chief Executive Officer of Milestone Scientific, added, "This second submission focusing on morbidly obese patients follows our earlier submission focusing on a broader patient population. Moreover, unlike procedures utilizing fluoroscopy, CompuFlo® has the added potential benefit of avoiding patient exposure to radiation without compromising procedure safety or efficacy."
About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.milestonescientific.com.
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