Sapien heart valve gets FDA approval
"A newer incarnation of the Sapien transcatheter heart valve may lower the risk of major vascular complications compared with the first-generation device.
Although the overall short-term performance was similar between patients on both the Sapien THV and the newer Sapien XT, patients with the XT had significantly fewer major vascular events (11.1% versus 33.3%, P=0.004), according to Antonio Colombo, MD, of San Raffaele Scientific Institute in Milan, and colleagues.
They reported their findings in the July issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.
An FDA panel recommended approval of the first-generation valve earlier this week. FDA advisory committee panelist Ralph Brindis, MD, of Kaiser Permanente in Oakland, Calif., said the second-generation device is being evaluated in the PARTNER II trial and will likely be submitted for approval upon completion of that study".
Read full report here (from Medpagetoday.com)
"A newer incarnation of the Sapien transcatheter heart valve may lower the risk of major vascular complications compared with the first-generation device.
Although the overall short-term performance was similar between patients on both the Sapien THV and the newer Sapien XT, patients with the XT had significantly fewer major vascular events (11.1% versus 33.3%, P=0.004), according to Antonio Colombo, MD, of San Raffaele Scientific Institute in Milan, and colleagues.
They reported their findings in the July issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.
An FDA panel recommended approval of the first-generation valve earlier this week. FDA advisory committee panelist Ralph Brindis, MD, of Kaiser Permanente in Oakland, Calif., said the second-generation device is being evaluated in the PARTNER II trial and will likely be submitted for approval upon completion of that study".
Read full report here (from Medpagetoday.com)
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