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Evaluation of the Edwards Lifesciences SAPIEN transcatheter heart valve. [Review]

MedStar author(s):

Citation: Expert Review of Medical Devices. 11(6):553-62, 2014 Nov.PMID: 25109297Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Research Support, Non-U.S. Gov't | ReviewSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Heart Valve Prosthesis | *Prosthesis Implantation/mt [Methods] | Aortic Valve/su [Surgery] | Equipment Design | Equipment Failure Analysis | Evidence-Based Medicine | Humans | Technology Assessment, BiomedicalISSN:

1743-4440

Name of journal: Expert review of medical devicesAbstract: Severe aortic stenosis is a common valvular disease and is associated with both morbidity and mortality. Surgical aortic valve replacement was the only available therapeutic option until technological advances allowed for the development of a transcatheter heart valve system. The first available THV was the Edwards SAPIEN. The merits of this system in terms of safety and efficacy were explored in the pivotal Placement of AoRTic TraNscathetER (PARTNER) randomized trial whose results then led to the approval of this device for commercial use in the US. The valve is now indicated for inoperable patients and may be considered an alternative for surgery for high-risk patients. Two successive models, the XT and more recently the S3, were developed with the intent to improve procedural outcomes. In this article, the SAPIEN transcatheter heart valve family is described in terms of technology, scientific data and future directions.All authors: Minha S, Waksman RDigital Object Identifier:

http://dx.doi.org/10.1586/17434440.2014.947272

Date added to catalog: 2016-01-13

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Title notes ( 2 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article		Available		25109297

Severe aortic stenosis is a common valvular disease and is associated with both morbidity and mortality. Surgical aortic valve replacement was the only available therapeutic option until technological advances allowed for the development of a transcatheter heart valve system. The first available THV was the Edwards SAPIEN. The merits of this system in terms of safety and efficacy were explored in the pivotal Placement of AoRTic TraNscathetER (PARTNER) randomized trial whose results then led to the approval of this device for commercial use in the US. The valve is now indicated for inoperable patients and may be considered an alternative for surgery for high-risk patients. Two successive models, the XT and more recently the S3, were developed with the intent to improve procedural outcomes. In this article, the SAPIEN transcatheter heart valve family is described in terms of technology, scientific data and future directions.

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