NHLBI SBIR/STTR Contract Topic

(Fast-Track proposals will be accepted.)

Number of anticipated awards: 1

Budget (total costs): Phase I: $150,000 for 12 months; Phase II: $1,000,000 for 2 years

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.

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.

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.

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 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.

A phase I award would develop and test a bioptome prototype. The awardee deliverable would be tested in vivo in the contracting Division of Intramural Research (DIR) lab (cardiovascular intervention program).

The specific deliverable would be:

• 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 shapeable to impart a curve analogous to Stanford-style endomyocardial bioptome
• Suitable for transjugular or transfemoral biopsy of the right ventricle or transfemoral retrograde aortic biopsy of the left ventricle
• Free from clinically-important heating (2oC at 1W/kg SAR) during MRI at 1.5-3.0T
• 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
• Proposals for alternative visualization strategies, such as "active" or "inductively-coupled" receiver coils, are welcomed.

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 would perform an IDE clinical trial at no cost to the awardee. IDE license or 510(k) clearance would constitute the deliverable.

The specific deliverable would be:

• 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 shapeable to impart a curve analogous to Stanford-style endomyocardial bioptome
• Suitable for transjugular or transfemoral biopsy of the right ventricle or transfemoral retrograde aortic biopsy of the left ventricle
• Free from clinically-important heating (2oC at 1W/kg SAR) during MRI at 1.5-3.0T
• 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
• Proposals for alternative visualization strategies, such as "active" or "inductively-coupled" receiver coils, are welcomed.