Biological and mechanical therapies enabled by cardiovas

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During the past year we have continued our work applying rapid MRI to guide simple and complex mechanical and biological interventions. We are developing clinical-grade catheter devices to recanalize chronic total occlusions of peripheral arteries. These should be ready for clinical testing next year. Other catheter devices also are under development for real-time MRI procedures in animals. We are developing catheter-based mitral annuloplasty to treat functional mitral valve regurgitation. We have had preliminary success in porcine models of mitral valve regurgitation. Preclinical studies of mobilized, apheresed, bone-marrow cell translocation into myocardium did not demonstrate benefit in small and large mammal models of acute myocardial infarction or chronic myocardial ischemia. We have deferred further clinical development of these strategies. We have developed methods to combine or "fuse" prior MRI-derived regions of interest with real-time X-ray during preclinical and clinical catheter-based procedures. For example, our X-ray Fused with MRI (XFM) system facilitated precise injections to myocardial targets under X-ray fluroscopy. We plan further development of these technologies to facilitate widespread deployment. Clinical studies are about to begin conducting human peripheral artery intervention wholly using real-time MRI, and stenting of aortic coarctation in humans wholly using real-time MRI. Clinical enrollment continues in a human gene transfer experiment for therapeutic angiogenesis using a novel transcriptional upregulator; the trial will test safety as well as MRI assessment of efficacy.