We’ve reported on Medtronic’s alternative subclavian approach for installing its CoreValve System in the past, and now the company has announced a new study which further demonstrates the procedure’s safety and efficacy. The CoreValve system allows for replacement of a stenosed aortic valve via a catheter, without the need for open heart surgery. The procedure was CE marked last December, making CoreValve the only transcatheter aortic valve implantation system approved for use via subclavian approach.
From the press release:
The multi-center study evaluated 132 consecutive subclavian patients in Italy and found positive patient outcomes, despite patients in the subclavian group being sicker than patients in the femoral access group (based on EuroSCORE and rates of peripheral artery disease, coronary artery disease, prior stroke and prior heart attacks). Procedural success was obtained in 97.7 percent of the subclavian group versus 96.3 percent of the transfemoral group, with intraprocedural mortality of 1.5 percent versus 1.8 percent, respectively. No serious complications were reported as a result of accessing the aortic valve through the subclavian artery. Freedom from cardiac death rates were almost identical (90.6 percent versus 90.4 percent, respectively), and freedom from major adverse cardiac event rates were 87.6 percent for the subclavian group versus 86.3 percent for the femoral group.
Press release: Study Provides Insight on Medtronic CoreValve® System Implants Through Subclavian Approach…
Product page: CoreValve…
Flashbacks: Medtronic’s CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial…; CoreValve Aortic Valve Replacement System Now With AccuTrak Stability Layer…; Medtronic’s CoreValve Clinical Trial Receives FDA Approval…; Subclavian Approach for CoreValve Transcatheter Aortic Replacement Gets European OK…
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