SAN FRANCISCO The 2013 edition of Transcatheter Cardiovascular Therapeutics is underway, and the weather in the City by the Bay is remarkably clear, but one thing is not clear regarding transcatheter aortic valve replacements; how their manufacturers will grown their geographic markets in the near term. David Cohen, MD, of the Mid America Heart Institute (Kansas City, Missouri), told attendees that where TAVR is concerned, "the economic issues are paramount," and that at least some research clearly indicates that the technology is as yet too costly for most societies, even many of those in the West.

Abbott (Abbott Park, Illinois) has received FDA PMA approval for its catheter-based MitraClip therapy for mitral regurgitation (MR) and the company says it plans to launch the device immediately in the U.S. The MitraClip device has been approved for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.