LIJ Medical Center Offers New Embolic for Minimally Invasive Procedure to Treat Uterine Fibroids

January 20, 2009

For the tens of thousands of women in the United States facing a procedure to treat uterine fibroids each year, a new embolic is now available at LIJ Medical Center that may help reduce inflammation and pain after a non-surgical radiology procedure known as uterine fibroid embolization (UFE).

The treatment team at LIJ, headed by David Siegel, MD, chief of vascular/interventional radiology of the North Shore-LIJ Health System, is only the second physician in the country to implant the new synthetic particles or microspheres. The product, Embozene™ Color-Advanced Microspheres, recently approved by the U.S. Food and Drug Administration for the treatment of hypervascular tumors and arteriovenous malformations, is manufactured by CeloNova BioSciences, Inc. of Newnan, GA.

In UFE, the physician makes a tiny incision in the crease between the lower abdomen and the top of the thigh, and introduces a catheter into the femoral artery. Using X-ray guidance, the catheter is directed to the artery that supplies blood to the non-cancerous fibroid tumors. Tiny particles, about the size of a salt crystal, are injected into the artery. The particles block the small arteries that supply blood and oxygen to the tumors causing them to die and shrink over a period of months.

Embozene™ Microspheres, made of a patented polymer, are the only microspheres to be color-coded by particle size for increased procedural safety, efficiency and visibility. According to CeloNova, the new microspheres are different from other spherical embolics in terms of biocompatibility, precise calibration, stable suspension and structural stability. “The European clinical results of the Embozene™ Microspheres suggest that the new implants may help to reduce post-op inflammation and pain, improving patient outcomes,” said Dr. Siegel, who has performed over 1,000 UFE’s and last year visited a German hospital to observe first-hand how the new microspheres performed during a procedure. “The particles have the highest level of biocompatibility, and are precisely and uniformly sized during manufacturing, which can only enhance efficacy.”

Embozene™ Color-Advanced Microspheres are the world’s first microspheres that have been color-coded by particle size for improved visibility and increased procedural safety.

It takes 30 to 60 minutes to perform a uterine artery embolization. Most patients are discharged from the hospital the morning after the procedure, while those with the mildest symptoms may be discharged even earlier.

Uterine fibroids are benign tumors that form on the uterus. They occur most often in women between the ages of 35 and 50. African-American women and those with a family history are more likely to develop fibroids. Even though these tumors are not malignant, they can cause prolonged bleeding, anemia, abdominal swelling and pelvic pain. They are also the leading cause of hysterectomy in pre-menopausal women. According to Dr. Siegel, up to 80 percent of women with fibroids can be treated with UFE. For women who do not meet the criteria for the minimally invasive procedure, surgical procedures are available to remove fibroids.

“The Division of Vascular/Interventional Radiology at LIJ runs a clinical practice at the hospital, with a full continuum of care for patients with uterine fibroids,” said Dr. Siegel. “There is always a consulting gynecologist involved and we cooperate closely with the GYN service in caring for these patients. In addition, our nurse practitioner provides patient education before the procedure and follows up afterwards.”

For more information about uterine fibroid embolization at LIJ, call (718) 470-4143; or North Shore University Hospital at (516) 562-4771.

About North Shore-LIJ Health System The nation's third largest, non-profit, secular healthcare system, the North Shore-LIJ Health System cares for people of all ages throughout Long Island, Queens and Staten Island – a service area encompassing more than five million people. The health system consists of 15 hospitals, 17 long-term care facilities, The Feinstein Institute for Medical Research, five trauma centers, five home health agencies, a hospice network and dozens of outpatient centers. In addition, North Shore-LIJ is partnering with Hofstra University to develop a new medical school. Excluding its affiliate organizations, North Shore-LIJ facilities house 4,844 beds, have more than 7,000 physicians, and employ about 9,150 nurses and a total workforce of about 33,250 -- the largest employer on Long Island and the ninth largest in New York City. For more information, go to www.northshorelij.com.

About CeloNova BioSciences, Inc. Headquartered in Newnan, near Atlanta, Georgia, CeloNova BioSciences, Inc., is a developer of novel medical devices that are then enhanced by one of the company’s proprietary materials, Polyzene®-F. Polyzene®-F is highly lubricious, anti-inflammatory, and bacterial-resistant making it an ideal surface treatment for implanted medical devices. The company’s current products include Embozene™ Microspheres which are FDA approved in the US for the treatment of hypervascular tumors and arteriovenous malformations. For more information, please visit www.celonova.com.

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May 17, 2010
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