Transcription of Embosphere - Merit Medical
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Embosphere - Merit Medical
EnglishINSTRUCTIONS FOR USEEMBOSPHERE microspheres IN A PREFILLED SYRINGE - FOR EMBOLIZATIONCAUTION: Federal ( ) law restricts this device to use by or on the order of a licensed USEE mbosphere microspheres are indicated for use in the embolization of: Hypervascular tumors, including symptomatic uterine fibroids Arteriovenous malformations Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH) in people with medication-refractory urinary obstructive symptoms who are poor surgical candidates or refuse surgical APPLICATIONS FOR UTERINE FIBROIDSU terine fibroid embolization (UFE) is an alternative treatment for women requiring treatment for relief of symptoms attributed to uterine fibroids including heavy menstrual bleeding, pelvic pain or pressure, and/or urinary APPLICATIONS FOR BENIGN PROSTATIC HYPERPLASIA (BPH)Prostatic artery embolization (PAE) is an alternative treatment for men requiring treatment for relief of lower urinary tract symptoms (LUTS)
Embosphere Microspheres are made of tris-acryl polymer impregnated with porcine gelatin and have no ferrous composition. DEVICE DESCRIPTION: Embosphere Microspheres are part of a family of embolic materials based on Merit Medical’s proprietary microsphere technology. These spheres are designed to offer controlled, targeted embolization.
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