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TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.

The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.

WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

The WellsForm™ Tricuspid Annuloplasty Band is an implantable ring intended for surgical repair of the tricuspid heart valve. WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus. The WellsForm™ Tricuspid Annuloplasty Band consists of a braided textile polyester body with a semi-rigid (stiflened) portion at the septal and aortic segments. The flexible section runs from the aortic segment, about half of the posteroseptal commissure to help remodel and stabilize the enlarged portion of the tricuspid annulus found in patients with functional tricuspid requrgitation. The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).

Memo 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or stenoinsufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty. The use of the MEMO 3D ReChord device is indicated for use in patients suffering from congenital or acquired mittal insufficiencies or steno-insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty. The use of the Memo 4D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficient with dilatation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae tendineae and payillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Like their predicate devices, the subject MEMO 3D, MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings are supplied as sterile, nonpyrogenic ring pre-mounted on disposable holders. Both the predicate and subject devices are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone. The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread. Both the predicate and subject devices MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread. The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring. The MEMO 3D and MEMO 3D ReChord Annuloplasty Rings are manufactured in 8 different sizes, from 24 to 38 mm, with 2 mm increments. The MEMO 4D Annuloplasty Ring is manufactured in 10 different sizes, from 24 to 42 mm, with 2 mm increments. A complete set of accessories is available separately to properly size the annulus and implant the MEMO 3D, MEMO 3D ReChord and MEMO 4D annuloplasty ring.

The TruForm™ Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

The TruForm™ Sievers Annuloplasty Ring, Model TRH is a semi-flexible implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of braided polyester encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm.

The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus. The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.

The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation. The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut. The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring. The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

The Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.

The Physio Flex annuloplasty ring is a semi-rigid, open, mitral annuloplasty ring with an asymmetrical open anterior segment. The ring has an asymmetrical open anterior segment corresponding to the mitral annulus below the aorto-mitral curtain. The complete portion of the ring begins at the anterolateral commissure and extends beyond the posteromedial commissure and the posteromedial trigone into the anterior annulus. The ring design has a rectangular Nitinol core which enables different flexibilities in-plane and out-of-plane. The ring flexibility progressively increases in-plane from size 24 mm to 30 mm. It remains relatively constant from size 30 mm to 40 mm. For each ring size, the out-of-plane flexibility is greater than the in-plane flexibility. The ring also has a progressive saddle height with a complete posterior saddle and an open anterior saddle. The ratio of the saddle height to the A-P (antero-lateral to postero-medial) dimension progressively increases from size 24 mm to size 36 mm. It remains constant from size 36 mm to 40 mm. The Nitinol core is covered with a silicone sleeve and an external, knitted, polyester cloth. The sewing cuff is designed for ease of needle penetration and suture placement. A green circumferential suture line placed between the outer perimeter of the ring and the outer perimeter of the Nitinol core identifies the suture placement area. The ring has two commissure markers and a mid-posterior marker to facilitate orientation during implantation. The ring incorporates a holder with a proximal arm for connection to handle models 1150 and 1151. The holder arm is designed with a section made of stainless steel that can be bent to facilitate access and positioning of the ring on the valve annulus. The Physio Flex annuloplasty ring is available in sizes 24, 26, 28, 30, 32, 34, 36, 38 and 40 mm. The Physio Flex annuloplasty ring is designed to be used with sizer model 1252.

The NeoForm™ Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.

The NeoForm™ Annuloplasty Ring, Model 4200 is a rigid implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of polyester fabric encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in four sizes: 26 mm; 28 mm; 30 mm; and 32 mm.

The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.

The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band: - The end of the stiffener section at the posteroseptal commissure. - The anteroposterior commissure. ● - The end of the stiffener section in the anterior segment of the band. ● A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.

MEMO 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies. The use of the Memo 4D device is indicated for correction of congenital insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Like its predicate device (the MEMO 3D ReChord Semirigid Annuloplasty Ring, K142221), the MEMO 4D Semirigid Annuloplasty Ring is supplied as a sterile, non-pyrogenic ring pre-mounted on a disposable holder. Both the predicate and subject device are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone. The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread. Both the predicate and subject device feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread. The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring. The following changes were implemented: The MEMO 4D is available in two new sizes: 40mm and 42mm. The MEMO 4D features a larger silicone filler layer in the outer portion of the ring, intended to further facilitate ring suturing to the annulus. A re-shaping of the MEMO 4D annuloplasty ring was implemented for sizes 34 to 42 mm. These sizes maintain the same core cross-sectional diameter and commissure-to-commissure dimension as the predicate MEMO 3D ReChord, but feature a gradual increase of the ring antero-posterior dimension and an out-of-plane "saddle" shape in the anterior ring portion. The ring re-shaping creates a differentiated design for the MEMO 4D with respect to the MEMO 3D ReChord. The design includes a rounder shaped implant to accommodate cases of excess leaflet tissue which may be indicative of degenerative mitral disease. Minor design changes to the disposable holder to adapt to the modified ring shape and a new injection molding supplier for the holder were also introduced. The MEMO 4D packaging system was redesigned, introducing a double nested blister to replace the polysulfone containers used for the predicate MEMO 3D ReChord. A complete set of accessories is available separately to properly size the annulus and implant the MEMO 4D annuloplasty ring.

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.