Description:
Summary
MRI-guided catheter procedures can avoid radiation and may allow surgery to be avoided in a range of applications. A safe clinical guidewire is not commercially available. A complex “active” electronic MRI guidewire is being developed by DIR. However, a more simple and versatile “passive” MRI guidewire also is valuable to be used as part of multi-step procedures (such as catheter exchange), but is neither commercially available nor attractive to manufacture in DIR. Several prototypes have been reported in the literature but none have been commercialized. Such a device would have utility in cardiovascular and in non-cardiovascular applications.
This contract solicitation is to obtain an exchange-length guidewire that is safe for operation during MRI.
Project Goals
The goal of the project is to develop an exchange-length guidewire that is safe for operation during MRI. First a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing at NIH. The deliverable would likely have fixed development costs and low marginal production costs, and therefore is suitable for commercialization after initial SBIR investment.
Phase I Activities and Expected Deliverables
A phase I award would develop and test a guidewire prototype. The awardee deliverable would be tested in vivo in the contracting DIR lab (cardiovascular intervention program).
The specific deliverable would be:
• 0.035” outer diameter x 2.6-3.0 meters length allowing unencumbered catheter exchange
• Mechanical properties matching up to two commercially available X-ray guidewires, in descending priority order: (1) Wholey {steerable and torquable angled guidewire}, (2) Supra-Core {steerable and torquable shapeable soft-tip and stiff-shaft}
• Shapeable tip is strongly preferred over a J tip
• Free from clinically-important heating (2oC at 1W/kg SAR) during MRI at 1.5-3.0T
• Visibility during MRI. If using individual susceptibility markers, they should be positioned at the tip and along the shaft in a pattern that allows the operator to delineate/differentiate them. Susceptibility markers should be > 3mm in diameter using commonly used steady state free precession or fast gradient echo MRI techniques
• Proposals for alternative visualization strategies, such as “active” or “inductively-coupled” receiver coils, are welcomed.
Phase II Activities and Expected Deliverables
A phase II award would allow mechanical and electrical testing and regulatory development for the device to be used in human investigation, whether under Investigational Device Exemption or under 510(k) marketing clearance. The contracting DIR lab would perform an IDE clinical trial at no cost to the awardee.
The specific deliverable would be:
• 0.035” outer diameter x 2.6-3.0 meters length allowing unencumbered catheter exchange
• Mechanical properties matching up to two commercially available X-ray guidewires, in descending priority order: (1) Wholey {steerable and torquable angled guidewire}, (2) Supra-Core {steerable and torquable shapeable soft-tip and stiff-shaft}
• Shapeable tip is strongly preferred over a J tip
• Free from clinically-important heating (2oC at 1W/kg SAR) during MRI at 1.5-3.0T
• Visibility during MRI. If using individual susceptibility markers, they should be positioned at the tip and along the shaft in a pattern that allows the operator to delineate/differentiate them. Susceptibility markers should be > 3mm in diameter using commonly used steady state free precession or fast gradient echo MRI techniques
• Proposals for alternative visualization strategies, such as “active” or “inductively-coupled” receiver coils, are welcomed.
