Johnson & Johnson10.03.18
Johnson & Johnson Medical Devices Companies has announced that MENTOR Worldwide LLC, a global leader in breast aesthetics, has introduced a tissue expander with a smooth surface to its line of CPX4 Breast Tissue Expanders in the United States.
Tissue expanders are used for breast reconstruction after mastectomy to expand the breast pocket to accommodate a breast implant. The new CPX4 device has a smooth surface designed to help ease insertion and removal,1 and now includes additional suture tabs2 to enhance fixation while reducing the risk of rotation for subcutaneous and submuscular breast reconstruction.
“I am looking forward to using the CPX4 Smooth expander in prepectoral and submuscular breast reconstruction,” said Mark Migliori, M.D.,** a board certified plastic surgeon in Edina, Minn. “I believe it will offer ease of use during placement and removal with the added protection of the proprietary BufferZone, along with providing a natural breast shape and a soft comfortable expander for the patient.”
About one in eight women in the United States will develop invasive breast cancer over the course of their lifetime. In 2018, this means an estimated 266,120 new cases of invasive breast cancer are expected to be diagnosed.3Tissue expanders are used for breast reconstruction after mastectomy to expand the breast pocket to accommodate a breast implant. The new CPX4 device has a smooth surface designed to help ease insertion and removal,1 and now includes additional suture tabs2 to enhance fixation while reducing the risk of rotation for subcutaneous and submuscular breast reconstruction.
“I am looking forward to using the CPX4 Smooth expander in prepectoral and submuscular breast reconstruction,” said Mark Migliori, M.D.,** a board certified plastic surgeon in Edina, Minn. “I believe it will offer ease of use during placement and removal with the added protection of the proprietary BufferZone, along with providing a natural breast shape and a soft comfortable expander for the patient.”
MENTOR also has plans to expand its portfolio of breast implants to broaden access for women who currently have few sizing options. In 2015, the company received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its ATHENA4 clinical trial, which is evaluating the safety and effectiveness of larger sizes of MENTOR MemoryGel Breast Implants for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue.
The ATHENA study is the largest pre-approval, manufacturer-sponsored breast implant clinical trial registered with the FDA to date, in terms of number of reconstruction patients enrolled. As of September 2018, more than 330 women across 32 investigational sites have been enrolled. MENTOR anticipates completing enrollment of the full 400 patients by the end of 2018.
MENTOR Worldwide LLC is a supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR is the only manufacturer whose silicone breast implants are made in the United States.
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
** Mark Migliori is a paid consultant to MENTOR Worldwide LLC.
References
1. Internal R&D document #100617163
2. CPX4 Smooth has additional tabs compared to CPX4 Siltex
3. https://www.breastcancer.org/symptoms/understand_bc/statistics (Accessed September 4th 2018)
4. https://clinicaltrials.gov/ct2/show/NCT02724371 (Accessed September 4th 2018)
