BioSphere says non-surgical hysterectomy alternative effective, safe

By Elaine Rigoli

Tampa, Fla., March 30 - BioSphere Medical said its three-year, multi-center study of more than 100 patients showed that minimally invasive uterine fibroid embolization using its Embosphere Microspheres is safe and effective, provides high levels of durable symptom control and improves health-related quality of life and patient satisfaction.

This is the first long-term data presented with trisacryl gelatin microspheres, which were not yet available when Biosphere started to perform uterine fibroid embolization in the mid 1990s, according to a news release.

Uterine fibroid embolization is a non-surgical treatment alternative to hysterectomy that uses a small catheter to deliver miniature microspheres into the blood vessels, disrupting blood supply to the fibroids. As a result, the fibroids are devitalized without permanent injury to normal uterine tissue.

BioSphere's Embosphere Microspheres product is the first of only two embolics that currently have a specific indication for uterine fibroid embolization and the only embolic made of an acrylic copolymer cross-linked with gelatin, the company said.

Of the more than 100 participating patients, 96 had complete baseline data for evaluation and of these, 64% completed long-term follow up, according to the release.

At three years, other key findings include:

• 83% of patients experienced much or moderate improvement in pelvic pain;

• 69% reported improvement of urinary problems;

• 84% of patients were moderately or very satisfied with their outcome;

• 8.3% of patients subsequently underwent fibroid surgery (seven hysterectomies and one myomectomy).

According to the Society of Interventional Radiology, 20% to 40% of American women 35 and older have uterine fibroids and nearly 50% of pre-menopausal African-American women have fibroids of a significant size.

These benign tumors can cause prolonged, heavy menstrual bleeding that can lead to anemia, disabling pelvic pain and pressure, urinary frequency, pain during intercourse, miscarriage and interference with fertility.

Of the 600,000 hysterectomies performed annually in the United States, one-third are to relieve symptoms caused by fibroids, the company said.

BioSphere Medical, Inc., a medical device company based in Rockland, Mass., develops minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.