Interlace Medical Inc. launched a clinical trial of its MyoSure fibroid surgery device, aiming to prove that women experience little pain or discomfort during the procedure.
The Framingham, Mass.-based firm’s myomectomy system is a minimally invasive technique that allows for the removal of submucosal fibroids and polyps in a single, out-patient procedure. Submucosal fibroids are benign tumors that grow just beneath the endometrial lining of the uterus.
Interlace said the 40-subject study will enroll patients with intrauterine polyps and/or submucosal fibroids of 3cm or less and submit the results to a peer-reviewed journal for publication after the trial concludes in March 2010. The patients will undergo the MyoSure procedure under a mild oral sedative and a local anesthetic injected into the cervix.
The company won 510(k) clearance for the device in October 2009. In June, Interlace raised nearly $21 million in a Series C funding round to begin commercializing the device.
