November 14, 2017

Texas Children’s Pediatric and Adolescent Gynecology Division was recently awarded an NIH Small Business Innovation Research grant via Biotex Inc. to develop vaginal stents that will help vaginal reconstructive patients heal.

The most common complication after vaginal reconstruction is restenosis and scar tissue formation, which can occur in up to 73 percent of patients. As many as 50,000 girls a year and 213,000 women could benefit from postoperative treatment using newly designed vaginal stents.

There currently are no vaginal stents on the market for the pediatric population, forcing physicians to use makeshift devices fashioned from surgical gloves or other materials. “Therefore, there is a tremendous need to help these patients and their physicians with a simple device that can truly improve their quality of life beyond even the surgery,” said Texas Children’s pediatric and adolescent gynecologist Dr. Julie Hakim.

“In creating the first vaginal stent specifically designed to address the anatomic needs of the pediatric and adolescent populations, we aim to reduce early discontinuation of stent postoperatively and improve postsurgical outcomes,” she said.

Phase I testing is ongoing and submission for a grant for a Phase II clinical trial is anticipated to occur in April.

May 3, 2016

42716Dietrichgrantinside640Dr. Jennifer Dietrich, chief of Pediatric and Adolescent Gynecology, and Dr. Julie Hakim, Pediatric and Adolescent Gynecology fellow, have been awarded $50,000 recently by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) for their work on customizable 3-D printed pediatric vaginal stents and vaginal dilators. The stents and dilators are designed for girls born with congenital vaginal abnormalities.

This is the third year the NCC-PDI has held a competition to recognize and fund new and innovative pediatric devices. In addition to receiving the funding, the NCC-PDI will share its expertise in design development and help bring the funded products to market. From the 37 applications this year, six were chosen for funding.

“Because of the need for dilators or vaginal stents determined by women born with congenital anomalies of the reproductive tract and by women who have undergone surgery or radiation for gynecologic cancers, we know there is a market for customized devices such as these,” Dietrich said.

“It has been an incredible learning process during my fellowship to move from seeing a need among our pediatric patients undergoing vaginal surgery, to IRB and IACUC approval, to prototyping and now to company formation and product development. We are looking forward to our products providing better outcomes for our patients,” said Dr. Hakim.

NCC-PDI was formed in September 2013 through the FDA’s Pediatric Device Consortia Grant Program to provide infrastructure support and expert consultation on pediatric medical device development throughout the product development lifecycle.