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NHLBI SBIR/STTR Contract Topic

 

071 Electrophysiologic Catheters for Interventional MRI Ablation of Ventricular Tachycardia

(Fast-track proposals will be accepted)

Number of anticipated awards: 1-2

Background

Catheter-based ablation therapy is used to treat cardiac rhythm disorders. MRI may have value in targeting and assessing ablation lesions interactively during catheter based cardiac electrophysiology (EP) procedures. Real- time MRI EP ablation may be especially attractive to ablate mid-myocardial targets causing ventricular tachycardia in adults and children.
While technically feasible, there are no commercially available flexible catheter devices to perform EP ablation that are conspicuous and safe under real-time MRI guidance. Such technology, if commercialized, would enable novel treatments for ventricular tachycardia.

Specifications

The offering resembles a “conventional” deflectable multipolar catheter used to perform EP ablation procedures in geometry and in mechanical performance. These must be specified.

The offering must be conspicuous during MRI at 1.5T using “profiling” techniques such that positive contrast is provided along the entire intravascular device shaft and tip. The preferred catheter design for profiling is “active” such that the offering incorporates an intravascular MRI coil that allows the device and tissue to be imaged simultaneously. Alternative designs will be considered that provide high conspicuity during MRI.

The device must be able to obtain multi-channel local intracardiac electrograms. Suitable filtering functionality must be provided to connect the system to a commercial clinical EP recording and mapping system.

The device should be suitable for transcatheter endocardial application and for transthoracic intrapericardial epicardial application.

The device must be capable of radiofrequency ablation of ventricular myocardium during uninterrupted magnetic resonance imaging, which may require appropriate filtering. Alternative ablative energy sources may be proposed. Saline irrigation, or alternative target tissue cooling, should be integrated into the ablation system.

The device should interoperate during MRI with at least two other similar catheters that provide multipolar electrogram recording capability.

The offeror should consider capabilities to perform ventricular defibrillation in the MRI environment. The offering should operate with the interventional MRI system of the sponsoring NHLBI laboratory. The NHLBI currently uses 1.5T Siemens MRI systems and the proposed transmit-receive system must be compatible with these scanners (more details will be made available upon request). The offering must be “MRI safe” or “MRI contingent” to allow future clinical procedures, without heating or local magnetic field disruption according to accepted industry standards and should be designed for safety in a clinical environment. Control of the system should be possible from a bedside operator and from a console-based operator outside the radiofrequency MRI system shield. The system should not generate radiofrequency noise that interferes with MRI at 1.5T. The system should be safe for operators and patients inside and near the magnet bores. The system should not interfere with common commercial Bluetooth and other common radiofrequency patient physiologic telemetry systems used during MRI.

Deliverables

At the conclusion of Phase I, a candidate device design should be selected for clinical development based on in vivo performance of a mature prototype system nearing final design lock.

At the conclusion of Phase II, the offeror should obtain an investigational device exemption (IDE), and a supply of devices provided, for a first-in-human research protocol, involving at least 10 subjects, to be performed by the sponsoring NHLBI laboratory. The sponsoring NHLBI laboratory is willing to perform in vivo proof-of-principal experiments in swine, is willing to collaborate toward design of the clinical protocol, and is willing to provide clinical research services. The vendor is expected to perform or obtain safety-related in vivo experiments and data to support the IDE.

For more information, see the FY2012 Contract Solicitation or contact OTAC.

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Last Updated December 2011




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