Interlace begins trial of MyoSure fibroid treatment
This article was originally published in Clinica
Executive Summary
Interlace Medical has started a US trial of its MyoSure hysteroscopic tissue removal system, a treatment for uterine fibroids. The 40-patient study aims to show that women experience "minimal-to-no pain and discomfort" during the MyoSure procedure, which is carried out in a doctor's office under a mild oral sedative and local anaesthetic injected into the cervix. The study will include women with intrauterine polyps and/or submucosal fibroids of 3cm or smaller – Interlace (Framingham, Massachusetts) claims that the device can remove these in 10 minutes or less. MyoSure was granted FDA 510(k) clearance in October 2009 (www.clinica.co.uk, 29 October 2009). Fibroids are benign tumours in the uterus that can cause painful and heavy menstrual bleeding.