In the pilot clinical study, the results presented 100% success in crossing the target with no device-related perioperative clinically significant adverse events and no complications requiring intervention. We are also developing an add-on diagnostic tool and disruptive medical device for interventional gastrointestinal procedures.”Ĭlinical evaluation of the B-Laser™ device in the intended population was performed in a prospective, single-arm, multi-center, open-label, non-randomized pilot clinical study in 50 subjects in Europe, as well as in a pivotal, prospective, single-arm, multi-center, open-label, non-randomized IDE clinical study in 97 subjects in the US and Europe. “We also plan to leverage our B-Laser technology to develop additional devices to address significant unmet needs in other vascular indications, including lead extraction, CAD, Thrombectomy and Venous Disease.
This is the first 355nm laser system cleared in the US for this purpose and, according to the clinical results and the feedback that we received from physicians, it seems that this wavelength provides significant advantages over traditional 308nm excimer lasers in term of safety, efficacy, cost and ease of use. Yoel Zabar, CEO of Eximo Medical, commented, “This clearance represents a significant milestone for Eximo, as we can now offer the B-Laser Atherectomy System for PAD in the US. “The enrollment in both US and Europe was quick (6.5 months), and the study results up to six months have been very impressive despite treating diverse lesions such as calcium, thrombus, and restenosis including ISR, both above and below the knee.” The specific indication now approved by the FDA is: “The B-Laser Atherectomy System is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusion, including in-stent restenosis. The B-Laser is described as “a transformative 355nm wavelength laser technology designed to address unmet clinical needs for treating multiple vascular indications.” Eximo Medical, based in Rehovot, Israel, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD). Carl Meißner Henry William Auden (1894) Latin Phrase-Book, London: Macmillan and Co.Laser system treats Peripheral Artery Diseases including ISR.eximo in Gaffiot, Félix (1934) Dictionnaire illustré latin-français, Hachette.Lewis (1891) An Elementary Latin Dictionary, New York: Harper & Brothers Lewis and Charles Short (1879) A Latin Dictionary, Oxford: Clarendon Press
I banish Synonyms: ablēgō, exsulō, expellō, pellō, exportō, ēiciō, ēmittōĬonjugation Conjugation of eximō ( third conjugation)Įxēmptus + present active indicative of sumĮxēmptus + imperfect active indicative of sumĮxēmptus + future active indicative of sumĮxēmptus + present active subjunctive of sumĮxēmptus + imperfect active subjunctive of sum.
I release, deliver Synonyms: absolvō, persolvō, līberō, excipiō, vindicō, servō, exonerō Antonyms: refrēnō, coerceō, saepiō, officiō, obstō, comprimō, impediō, arceō, supprimō.
#EXIMO BEV MO FREE#
0 kommentar(er)
