Boston Scientific Announces FDA Clearance for Contour SE™ Embolic Agent for the Treatment of Uterine Fibroids
(March 29, 2004) -- Boston Scientific Corporation (NYSE: BSX) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Contour SE™ embolic agent for the treatment of uterine fibroids. Contour SE may be used in uterine fibroid embolization (UFE), a less-invasive alternative to surgery that generally spares the uterus in women with symptomatic uterine fibroids. The approval should bring a new treatment option to the millions of women who suffer from uterine fibroids.

According to the American College of Obstetricians and Gynecologists, 20 to 25 percent of all women will develop uterine fibroids. There are currently approximately six million women in the United States who suffer from symptomatic fibroids, with less than 20 percent receiving treatment. UFE is a procedure that blocks blood flow to vessels feeding the fibroid, offering women a less-invasive alternative to surgery.

In a multi-center clinical trial comparing UFE to surgical myomectomy in more than 130 patients with symptomatic uterine fibroids, 86 percent of the women in the UFE arm experienced an improvement in symptoms compared to 79 percent in the myomectomy arm. Moreover, the median time period before a patient could return to normal activity was seven days in the UFE arm, versus 37 days in the myomectomy arm. The study also showed a lower adverse event rate in the UFE patients compared to the myomectomy patients.

"This clinical trial was an important step in establishing UFE as an alternative to myomectomy, and the data shows clear advantages in terms of recovery time and complications," said Gary Siskin, M.D., Medical Director of Interventional Radiology at Albany Medical Center in Albany, New York. "This trial was the second large-scale multi-center trial sponsored by Boston Scientific comparing a less-invasive alternative to traditional surgical myomectomy. The results should help convince gynecologists and patients of the potential benefits of UFE."

"The results of this major trial and market clearance by the FDA will allow Boston Scientific to strengthen relationships with our customers as they look to expand their clinical practice through new modalities such as UFE," said Steve Moreci, Boston Scientific Senior Vice President and Group President, Endosurgery.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit:

This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and introduction, clinical trials, regulatory approvals, competitive offerings, intellectual property, litigation, the Company's relationship with third parties, the Company's overall business strategy, and other factors described in the Company's filings with the Securities and Exchange Commission.