Pivotal Clinical Trial for Zip-stitch Underway

KING OF PRUSSIA, Pa. - Oct. 18, 2023 - PRLog -- ZSX Medical today announced the achievement of the first clinical uses of Zip-stitch® in its pivotal U.S. clinical trial (the "ZIMS" trial). Zip‑stitch is a novel wound closure system for use in laparoscopic hysterectomy. The Zip-stitch system brings internal tissue together and maintains closure while healing occurs using a series of bio-absorbable surgical clips deployed with a laparoscopic applicator tool.

According to David Holtz, M.D., the national Principal Investigator from Lankenau Medical Center and Main Line Health, who conducted the first surgery in this study, "The Zip-stitch clips in the first patient went on smoothly and achieved a good surgical closure." Edward Tanner, M.D., a participating investigator from Northwestern University Feinberg School of Medicine and the lead surgeon in the second completed surgery in the ZIMS study, said, "We are excited to have started enrolling patients in the ZIMS study. If proven to be safe and effective in the trial, the Zip-Stitch device has the potential to simplify vaginal cuff closure at the time of minimally invasive hysterectomy."

About the ZIMS Clinical Trial

ZSX Medical's ZIMS [Zip-stitch In Minimally-invasive Surgery] trial (NCT05570916) is designed as a prospective, multi-center, randomized, controlled study to assess the safety and efficacy of the Zip‑stitch System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. The ZIMS trial is currently enrolling patients at multiple clinical sites.

About ZSX Medical, LLC

ZSX Medical, LLC, is a clinical-stage surgical device company making the hardest part of minimally invasive surgery fast and easy. ZSX's lead product, Zip-Stitch, addresses the challenge of internal closure following laparoscopic hysterectomy and is intended to give more patients access to minimally-invasive surgical options. Hysterectomy is the second most common surgical procedure undergone by women and is the debut opportunity for Zip-stitch as a platform of pre-fabricated bio-absorbable systems destined to change the standard-of-care in surgical closure. Zip‑stitch is limited to investigational use by Federal Law. For more information, visit www.zipstitch.com.

Dan Mazzucco, Ph.D.
President and CEO
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Tags:Medical Devices, Femtech, FemHealth, Hysterectomy, Surgery, Clinical Trials, Pivotal
Industry:Medical, Women, Research
Location:King of Prussia - Pennsylvania - United States
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