Description:
Direct to Phase II proposals will be accepted
Fast-Track proposals will be accepted.
Number of anticipated awards: 2
Budget (total costs): Phase I: $400,000 for up to 12 months; Phase II: $3,000,000 for 24-36 months
It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.
Summary
Endomyocardial biopsies are performed approximately 10,000 times each year worldwide. The procedure suffers large anatomic sampling error because of no current appropriate image guidance. Endomyocardial biopsy is currently performed without targeting, whether under X-ray or ultrasound guidance. This may account for the known low diagnostic yield and high sampling error.
MRI operation affords exquisite imaging and delineation of soft tissue beyond what is afforded by X-ray fluoroscopy, CT, and ultrasound guidance. Image-guided myocardial biopsy using MRI might enhance the diagnostic utility and safety of myocardial biopsy in inflammatory or infiltrative cardiomyopathies. This solution would be especially attractive in pediatrics, where the risk of and need for biopsy is higher than in adults, yet the need more frequent.
This solicitation aims to support the development of an MRI myocardial biopsy forceps and accessories for commercial clinical availability.
Project Goals
The goal of the project is to develop a myocardial biopsy catheter of materials safe for MRI operation yet sufficiently sharp to extract myocardial tissue effectively. First a prototype would be developed and tested in animals, and ultimately a clinical-grade device would undergo regulatory development for clinical testing.
This project should generate an Early Feasibility Study (EFS) IDE for clinical evaluation at NIH or another suitable medical center, towards commercialization through a mechanism such as Phase IIb bridge-to-commercialization. Alternatively it is possible that 510(k) market clearance can be achieved depending on the selected technologies.
Phase I Activities and Expected Deliverables
A phase I award would develop and test a bioptome prototype along with necessary accessories. The awardee deliverable would be tested in vivo at NHLBI DIR.
The specific deliverable would be:
• Myocardial biopsy forceps catheter with an outer diameter 6-7 French
• Bioptome sharpness equivalent or superior to commercially available stainless steel myocardial biopsy forceps catheters
• Able successfully to cut endomyocardial biopsy specimens 1-2mm x 2-3mm each
• Deflectable curve or shapable to impart a curve analogous to Stanford-style endomyocardial bioptome
• Suitable for transjugular or transfemoral venous biopsy of the right ventricle or transfemoral arterial retrograde aortic biopsy of the left ventricle
• Free from clinically-important heating (2oC at 1W/kg SAR) during MRI at 0.55T-1.5T
• Visibility during MRI. If visible using magnetic susceptibility phenomena, the tip should be distinctly visible, and at least the distal 40cm of the shaft should also be visible. In general, susceptibility markers should be > 3mm in diameter using commonly used steady state free precession or fast gradient echo MRI techniques.
• There should be a characteristic imaging signature that distinguishes the “open” from the “closed” position of the biopsy forceps, using MRI
• The deliverable includes all accessories necessary to perform right and left ventricular biopsy under real-time MRI guidance via a pre-positioned vascular introducer sheath. This specifically includes MRI-conspicuous guiding catheters or sheaths, whether pre-shaped or deflectable.
• Proposals for alternative visualization strategies, such as “active” or “inductively-coupled” receiver coils, are welcomed.
A phase I award would develop and test functioning MRI myocardial biopsy forceps system, including accessories, in vivo. The contractor should provide a detailed report of pre-IDE interactions with the Food and Drug Administration to identify requirements for premarket notification [510(K)] under Phase II, including the summary of mutual understanding.
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 may require tailored hardware compatibility with the NIH investigational MRI system, or the test can be performed by NHLBI DIR staff at an outside facility.
Phase II Activities and Expected Deliverables
A phase II award would allow mechanical and safety 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 offers to perform a IDE clinical trial at no cost to the awardee.
Proposals should include key milestone for contract review including FDA presubmission meeting(s), design lock, DFEA creation and completion, GLP experiments, etc.
IDE license or 510(k) clearance and 10 functioning clinical devices would constitute the deliverable.
