MARLBOROUGH, Mass., Nov. 1, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today the U.S. launch of the MyoSure® MANUAL device, which was designed to help doctors more easily resect and remove intrauterine tissue in office settings when used with the MyoSure hysteroscope.
The MyoSure MANUAL device joins the MyoSure suite of gynecologic surgical products. The complete MyoSure system is a minimally invasive hysteroscopic treatment for women with problematic tissue that requires no cauterization, which preserves uterine form and function. The system enables quick and convenient removal of tissue, including a range of fibroids and polyps that may be the root cause of Abnormal Uterine Bleeding (AUB), which affects up to 30% of pre-menopausal women.1
"We recognize the increased demand for in-office procedures, and seek to develop innovative solutions to provide flexibility and convenience for both physicians and patients," said Edward Evantash, M.D., Medical Director and Vice President of Medical Affairs, Hologic. "The MyoSure MANUAL device was designed for in-office tissue removal procedures, requiring minimal setup and no vacuum or fluid management system, while offering direct visualization when used with the MyoSure hysteroscope."
The MyoSure MANUAL device has a fully integrated vacuum that does not require external suction, and can be operated with a one-liter saline bag. There is no need for a controller or additional capital equipment for fluid management. The clear tissue trap allows visual confirmation of tissue removed during the procedure and holds up to 4g of tissue; it also detaches to send to pathology. In addition, the MyoSure MANUAL device gives physicians multi-function control of the 360° blade.
"The MyoSure MANUAL device is an exciting addition to Hologic's growing portfolio of gynecologic solutions, developed with the patient and physician in mind," said Sean Daugherty, President of GYN Surgical Solutions at Hologic. "This addition to the MyoSure product suite signals our ongoing commitment to providing effective surgical solutions that can be performed in office to address our customers' needs and improve the overall patient experience."
Other devices in the MyoSure suite of products include the MyoSure®, MyoSure® REACH, MyoSure® XL, and MyoSure® LITE devices.
For more information about the MyoSure MANUAL device, please see complete Instructions for Use .
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
Hologic, MyoSure, The Science of Sure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
Important Safety Information
The MyoSure® MANUAL Tissue Removal Device is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue. The MyoSure MANUAL Tissue Removal Device should not be used in a patient who is pregnant or suspects pregnancy, has clinical evidence of an active pelvic infection or history of a recent pelvic infection, or has cervical malignancies or previously diagnosed uterine cancer.
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.
This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to [email protected].
- Committee on Practice Bulletins—Gynecology. Practice bulletin no. 128: diagnosis of abnormal uterine bleeding in reproductive-aged women. Obstet Gynecol. 2012;120:197-206. doi: 10.1097/AOG.0b013e318262e320
SOURCE Hologic, Inc.