MTF Biologics Launches FlexHD Pliable PRE for Pre-Pectoral Breast Reconstruction

MTF Biologics expands its portfolio of innovations for post-mastectomy breast reconstruction with the launch of an acellular dermal matrix (ADM) designed specifically for pre-pectoral breast reconstruction procedures: FlexHD Pliable PRE.

Made from a proprietary process for faster integration, and fenestrated to conform and project naturally, the unique design of FlexHD Pliable PRE aims to minimize preparation time in the operating room.

FlexHD Pliable PRE was introduced during Plastic Surgery The Meeting, September 28-October 1, 2018, at McCormick Place West in Chicago.

“The pre-pectoral breast reconstruction procedure is becoming more popular because it can mean a shorter surgery, less pain and reduced recovery time for patients when compared to other methods,” says Tom Shaffer, executive vice President, global sales & marketing, at MTF Biologics, in a media release from the company.

“In talking with Plastic and Reconstructive Surgeons across the nation, it became clear that a new tissue form designed specifically for the pre-pec procedure would be useful. So, we teamed up with surgeons advancing this area of practice to examine how we could better serve that need, and with their feedback and guidance, FlexHD Pliable PRE was born.”

The pre-pectoral breast reconstruction procedure is the latest advancement in post-mastectomy breast reconstruction. As part of the procedure, an implant is placed over the chest muscle directly under the skin as opposed to under the muscle as is common in most reconstruction procedures. This method eliminates the need to cut into the muscle which may mean a shorter procedure in many cases as well as less pain during recovery, and less animation deformity in the reconstructed breasts longer term.

FlexHD Pliable PRE is designed to support and conform to the breast pocket, starting as a two-dimensional pattern that transforms into a three-dimensional shape to promote aesthetic symmetry.

“With bilateral pre-pectoral breast reconstruction, time and attention is needed to achieve proper projection and symmetry,” states Aldona Spiegel, MD, board certified plastic and reconstructive surgeon and director and founder of the Center for Breast Restoration at the Institute for Reconstructive Surgery at The Methodist Hospital in Houston, who is the innovator of the design.

“FlexHD Pliable PRE can be used as a template for both breasts improving symmetry and efficiency in the OR, helping to achieve more natural results.”

[Source: MTF Biologics]

Mentor Introduces New Tissue Expander

MENTOR Worldwide LLC 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, and now includes additional suture tabs 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,” says Mark Migliori, MD, a board certified plastic surgeon in Edina, Minnesota, in a media release.

“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,” he adds.

About 1 in 8 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.

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 US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its ATHENA 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, the release explains.

[Source: MENTOR Worldwide LLC]