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Medical equipment industry

FDA Approves Immediate MRI Exams for Patients with New TAXUS Stent System

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS(R) Express(2)(TM) paclitaxel-eluting coronary stent system, allowing patients to undergo Magnetic Resonance Imaging (MRI) examination immediately following implantation. This is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific's Express(2) bare-metal stent system also received approval for immediate MRI exams. Previously, patients receiving coronary stents were required to wait approximately two months before receiving an MRI.

Key Takeaways:

  • The FDA approval of the TAXUS Express(2) stent system has paved the way for immediate MRI exams for patients with this stent, eliminating the need for a two-month waiting period.
  • Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility, showing that the TAXUS Express(2) and Express(2) systems were safe at high levels of magnetic field strengths with minimal effect on temperature rise and drug release.
  • 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, as stated by Paul LaViolette, Boston Scientific Chief Operating Officer.
  • Physicians can review the revised TAXUS Express(2) stent DFU on the TAXUS website, and the revised Express(2) bare-metal stent DFU will be available shortly.
  • Angiotech Pharmaceuticals, Inc. has worldwide exclusive rights to use paclitaxel to coat its coronary stent products, and Boston Scientific has co-exclusive rights to other vascular and non-vascular products.

Statistics:

  • 2 months: The previous waiting period required before receiving an MRI for patients with coronary stents.
  • High magnetic field strengths: The levels up to which the TAXUS Express(2) and Express(2) systems were shown to be MRI safe.
  • Minimal effect on temperature rise and drug release: The result of Boston Scientific's laboratory testing demonstrating MRI compatibility.

Sources:

  • Boston Scientific Corporation ( press release, date not specified)
  • Angiotech Pharmaceuticals, Inc. (press release, date not specified)
  • U.S. Food and Drug Administration (FDA) (approval, date not specified)

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