MyoSure REACH

IMPORTANT SAFETY INFORMATION

The MyoSure^® tissue removal system, consisting of the MyoSure tissue removal devices (LITE, REACH, XL) and MyoSure controller, is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. The MyoSure MANUAL hysteroscopic tissue removal device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. MyoSure products are not appropriate for patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed uterine cancer.

For more details on risks and benefits of the MyoSure system, MyoSure MANUAL tissue removal device, MyoSure hysteroscope and the Aquilex^® fluid control system, please consult their respective IFUs.

The Fluent^® fluid management system is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

The Fluent fluid management system may not be used to introduce fluids into the uterus when hysteroscopy is contraindicated. The system should not be used to remove pathologies from pregnant patients or patients exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer. For detailed benefit and risk information, including contraindications relative to endometrial ablation, please consult the Instructions For Use.