Radius Coronary Stent With Delivery System

• 3 recalls, same reason

  • Terminated Z-0777-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003
  • Terminated Z-0778-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003
  • Terminated Z-0776-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003

  A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.

Trade Name

Scimed Radius Coronary Stent with Delivery System

Generic Name

STENT, CORONARY

PMA Number

P970061 ↗

FDA Product Code

MAF

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APWD Approval withdrawn

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  FDA 510(k) K012216 Active Cleared 17 Aug 2001

• Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System

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  FDA 510(k) K993232 Active Cleared 30 Dec 1999

• Schneider Guidezilla Softip Guiding Catheter

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  FDA 510(k) K935292 Active Cleared 10 Jun 1994

• Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

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  FDA 510(k) K000001 Active Cleared 5 Jun 2000

• Walstent Tracheobronchial Endoprosthesis

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  FDA 510(k) K961507 Active Cleared 10 Jul 1996

• Wallstent Tracheobronchial Endoprosthesis

  Class II

  FDA 510(k) K961296 Active Cleared 10 Jul 1996

See all devices from Boston Scientific Scimed, Inc. →

• What types of coronary artery lesions is the Radius Coronary Stent With Delivery System approved to treat, and what are the vessel size requirements?

  The Radius Coronary Stent With Delivery System is approved for treating discrete de novo native coronary artery lesions (new, isolated blockages) in patients with symptomatic ischemic heart disease. It is designed for vessels with a reference diameter between 2.75 mm and 4.25 mm and lesions under 30 mm in length. This ensures compatibility with specific coronary anatomy while maintaining safety and efficacy for the intended use.

• How is the Radius Coronary Stent With Delivery System supplied, and is it intended for single-use or reuse?

  The device is supplied as a single-use, sterile system for percutaneous coronary intervention (PCI), requiring catheter-based delivery via either the femoral or radial artery. Due to its permanent implantation design and regulatory classification as a Class III device, reuse is not recommended and would violate FDA-mandated sterility and safety protocols.

• What are the key differences between the various FEI numbers listed for this device, and how do they relate to the product’s configurations?

  The FEI numbers (e.g., 3016248656, 3002095335) correspond to different product configurations of the Radius Coronary Stent With Delivery System, including variations in stent diameter, length, or delivery system specifications. These identifiers are used for regulatory tracking and inventory management but do not alter the core indication (treating discrete de novo lesions in vessels 2.75–4.25 mm). Clinicians should refer to the manufacturer’s documentation for exact sizing details tied to each FEI.

• What is the regulatory pathway for the Radius Coronary Stent With Delivery System, and what does the FDA Premarket Approval (PMA) cover?

  The device received FDA Premarket Approval (PMA) under PMA number P970061, which means it underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use: treating discrete de novo native coronary artery lesions in vessels 2.75–4.25 mm with lesion lengths under 30 mm. The approval does not extend to off-label uses (e.g., chronic total occlusions, bifurcation lesions) or long-term outcomes beyond six months, as these were not established in the PMA submission.

• Is the Radius Coronary Stent With Delivery System compatible with both femoral and radial artery access, and how does this affect its use in clinical settings?

  Yes, the device is intended for delivery via either the femoral or radial artery, providing flexibility for clinicians based on patient anatomy, procedural preference, or risk factors (e.g., radial access may reduce bleeding complications). The delivery system’s design accommodates both routes, but the choice depends on factors like vessel tortuosity, lesion location, and institutional protocols—not the device’s specifications alone.