Boston Scientific's TAXUS® Express2™ Paclitaxel-Eluting Stent System First Drug-Eluting Stent To Receive FDA Approval Allowing Immediate MRI Exams
(April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS® Express2™ paclitaxel-eluting coronary stent system, indicating that patients receiving the stent systems may safely undergo Magnetic Resonance Imaging (MRI) examination immediately following implantation. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific's Express2 (bare-metal) stent system also received approval for immediate MRI exams. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI.

MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely.

Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release.

"The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. With our stent systems, MRI analyses can now be performed immediately."

Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at The revised Express2 bare-metal stent DFU will be available shortly.

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. Boston Scientific 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 commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.