Active MRI Transseptal Needle
Catheter access to the left atrium is a fundamental step to numerous transcatheter therapies including catheter ablation of rhythm disorders, diagnostic catheterization in pediatric and structural heart disease, and future treatments for mitral valve and left atrial appendage disease. MRI operation would enable radiation free catheterization and superior image guidance that are expected to enhance clinical outcomes. No MRI safe and conspicuous atrial transseptal needle is commercially available. ?Active? MRI catheter devices contain electronic elements to produce MRI visibility. This topic aims to support the development of an active MRI transseptal needle catheter and accessories.
The goals of this project are to develop and test an active MRI transseptal needle catheter prototype and accessories in vivo in Phase I, and in Phase II to develop a clinical device and obtain an FDA Investigational Device Exemption (IDE) for first human testing in the United States.
Phase I Activities and Expected Deliverables
A Phase I award would support the development and testing of actively visualized atrial transseptal needle system prototypes.
The deliverable is a complete clinically-relevant system including:
1. A transseptal needle;
2. Accompanying electronics, if needed to enable safe active visualization and interface to the host MRI hardware;
3. A transseptal introducer sheath, which should be visualized passively or actively using real-time balanced steady state free precession MRI;
4. A matched dilator to allow safe delivery of the introducer sheath over the needle, which must also be clearly visualized, preferably using active visualization. ?Active? refers to visualization by virtue of serving as a resonant antenna connected or coupled to the MRI hardware system.
The system should be free from clinically-important heating during continuous MRI at 1.5T. Proposals for novel alternative visualization and heat-mitigation strategies are welcomed.
The sheath should be 8.5Fr or smaller and approximately 71cm in length. Shapes should be available to accomplish transseptal puncture in a range of clinical applications; a deflectable sheath would be attractive.
The transseptal ?needle? functionality can be conferred using any combination of mechanical, electrical, acoustic, or photonic energy.
A solution must be provided for visualization of the ?active? electronic components using a real-time MRI system.
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 resembling a final design. Consideration for transition to Phase II funding will include progress toward regulatory clearance. Consideration may include the status of the contractor?s interactions with the Food and Drug Administration (FDA); therefore, contractors are encouraged to provide a detailed report of pre-IDE interactions with the FDA identifying requirements for IDE development under Phase II, including the summary of mutual understanding, if available. NHLBI encourages contractors to consider requesting designation to the FDA?s Expedited Access for PMA Devices (EAP) program (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf) during the Phase I award period.
The contracting DIR lab is willing to provide feedback about design at all stages of development. The contracting DIR lab will test the final deliverable device for success in vivo in swine. This requires specific hardware compatibility with the NIH Siemens Aera 1.5T MRI system.
Phase II Activities and Expected Deliverables
Phase II activities should include testing and regulatory development for the device with specifications as described in the Phase I Activities and Expected Deliverables section to be used in first-in-human investigation in the United States, whether under IDE or 510(k) marketing clearance. IDE license or 510(k) clearance would constitute the deliverable.
- Agency: Department of Health and Human Services,Department of Health and Human Services
- Program: SBIR
- Phase: Phase I
- Release Date: July 24, 2015
- Open Date: July 24, 2015
- Close Date: October 16, 2015
- URL: https://sbir.nih.gov/sites/default/files/PHS2016-1.pdf