That’s because the capital expenditure market is still under pressure from the weak economy, according to Leerink Swann analyst Richard Newitter, citing the un-named hospital CFO.
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"In the U.S., for Class III heart failure there are about 1.5 million patients," Sunshine Heart CEO David Rosa told MassDevice.com in an exclusive podcast interview. "That’s about 7 times the Class IV market, which is traditionally where LVADs participate."
TriVascular Inc. landed U.S. humanitarian device exemption approval for its Ovation abdominal stent graft system used to repair abdominal aneurysms.
The 20 mm Ovation system was approved by the FDA on Nov. 1 for use in patients with small iliac or femoral artery access of less than 7 millimeters.