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The HAART 200 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with bicuspid valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.

The HAART 200 Aortic Annuloplasty Device is designed to reshape the bicuspid valve annulus to a symmetric 180° configuration, to create circular annular geometry, and to improve leaflet coaptation by bringing both cusps toward the midline of the valve. It consists of a titanium frame covered with polyester fabric that is sewn onto the frame using braided polyester suture. The device has a circular base geometry and two subcommissural posts positioned 180° apart around its circumference. The device is available in four sizes: 19, 21, 23, and 25 mm. The device is provided attached to a disposable holder by means of a single polyester suture. Twelve (12) polyester pledgets are provided with each HAART 200 Aortic Annuloplasty Device. Both the device and pledgets are provided sterile by gamma irradiation sterilization and are intended for single-use. The HAART 201 Instrument Set provides accessory instruments to facilitate proper sizing and implantation of the device.

The HAART 300 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.

The HAART 300 Aortic Annuloplasty Device is designed to return aortic annular geometry toward normal for a given leaflet size and to assist in producing adequate leaflet competence by recovering normal coaptation geometry and area. It consists of a titanium frame covered with polyester fabric that is sewn onto the frame using braided polyester suture. The device has an elliptical base geometry and three subcommissural posts positioned 120° apart around its circumference. The device is available in four sizes: 19 mm, 23 mm, and 25mm. The device is provided attached to a disposable holder by means of a single polyester suture. Twelve (12) polyester pledgets are provided with each HAART 300 Aortic Annuloplasty Device. Both the device and pledgets are provided sterile by gamma irradiation sterilization and are intended for single-use. The HAART 301 Instrument Set provides accessory instruments to facilitate proper sizing and implantation of the device.