Integra LifeSciences Announces Complete Enrollment in DuraSorb® Monofilament Mesh U.S. IDE Study
28 Junho 2023 - 5:15PM
Integra LifeSciences Holding Corporation (Nasdaq:IART), a leading
global medical technology company, announced the completion of
patient enrollment in the DuraSorb U.S. investigational device
exemption (IDE) clinical study for two-stage breast reconstruction.
DuraSorb® Monofilament Mesh is a bioabsorbable matrix currently
510(K) cleared for the reinforcement of soft tissue where weakness
exists.
The DuraSorb IDE study, which is the first and only
active, prospective, multi-center IDE study in the U.S. evaluating
the use of a surgical matrix in two-stage breast reconstruction,
has enrolled several hundred patients from seven major academic
hospitals across the country sooner than anticipated. The purpose
of this study is to evaluate the safety and effectiveness of
DuraSorb to obtain pre-market approval (PMA) for use in patients
undergoing two-stage breast reconstruction. The primary follow-up
period is one year after device implantation.
“It is very exciting to see the completion of the
DuraSorb arm enrollment for this important prospective multi-center
study as well as the dedication of the medical professional teams
across the study sites,” said Dr. Yoon S. Chun, principal
investigator and section chief, division of plastic and
reconstructive surgery at Brigham and Women’s Faulkner Hospital in
Boston, Mass. “I look forward to completing this clinical
research which will have a significant impact on our ongoing work
to set new standards of care and achieve the highest quality
outcomes for women undergoing reconstructive breast surgery.”
“This is a significant milestone on our pathway to
a PMA for DuraSorb. We look forward to continuing to work with the
study investigators to maintain high patient follow-up,” said Todd
Cruikshank, vice president and general manager of Surgical
Innovation Associates (SIA), a business of the Tissue Technologies
division at Integra. “We are grateful to the investigators and
patients enrolled in this study which is intended to help advance
women’s health and improve patient outcomes following breast cancer
and mastectomy.”
Today, there are no FDA-approved surgical matrices
for implant-based breast reconstruction (IBBR). Integra remains the
only company actively progressing toward PMAs for surgical matrices
in breast reconstruction. In addition to the ongoing DuraSorb U.S.
IDE study, Integra was the first manufacturer to submit a PMA
application with SurgiMend® PRS, a surgical matrix for use as soft
tissue support in IBBR. Integra is on track to file a PMA update
for SurgiMend PRS with the FDA this August.
“Integra’s SurgiMend PRS, together with DuraSorb,
will enable us to provide surgeons with two distinct soft tissue
reinforcement solutions, which aim to address various clinical,
contracting, and economic needs across more sites of care,” added
Robert T. Davis, Jr., executive vice president and president of
Integra’s Tissue Technologies division. “Achieving these important
PMA milestones reinforces our commitment to our implant-based
breast reconstruction strategy, innovating new treatment pathways,
and restoring patient lives through technologies that transform
surgical care.”
About Integra LifeSciencesAt
Integra LifeSciences, we are driven by our purpose of restoring
patients’ lives. We innovate treatment pathways to advance patient
outcomes and set new standards of surgical, neurologic and
regenerative care. We offer a comprehensive portfolio of high
quality, leadership brands that include AmnioExcel®, Aurora®,
Bactiseal®, BioD™, CerebroFlo®, CereLink® Certas® Plus,
Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, DuraSorb®, Gentrix®,
ICP Express®, Integra®, Licox®, MAYFIELD®, MediHoney®,
MicroFrance®, MicroMatrix®, NeuraGen®, NeuraWrap™, PriMatrix®,
SurgiMend®, TCC-EZ® and VersaTru®. For the latest news and
information about Integra and its products, please visit
www.integralife.com.
Investor Relations:Chris Ward(609)
772-7736chris.ward@integralife.com
Media Contact:Laurene Isip(609)
208-8121laurene.isip@integralife.com
A photo accompanying this announcement is available
at
https://www.globenewswire.com/NewsRoom/AttachmentNg/c058d36c-a7d3-4f11-b612-d319cd823b9e
Integra LifeSciences (NASDAQ:IART)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Integra LifeSciences (NASDAQ:IART)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024