SBIR TOPIC 110, PHASE I - MRI MYOCARDIAL BIOPSY SYSTEM

SBIR Topic 110, MRI Myocardial Biopsy System: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.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.Under the Phase I award will develop and test a bioptome prototype along with necessary accessories.