Search Results

GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

GalaFLEX LITE Scaffold is a sterile, single-use device for prescription use only. It is a bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is a biologically derived polymer which is extruded into monofilament fibers and knitted into a surgical scaffold. The P4HB material is the predicate device, TephaFLEX Light Mesh (K113721) and the reference device, Phasix Mesh (K142818) in terms of formulation and the manufacturing processes. P4HB is absorbed by the body through a process of hydrolysis and hydrolytic enzymatic digestion typically within 18 to 24 months. The material components and manufacturing processes used to produce the subject device is substantially equivalent to the subject device will only be offered as a nondyed (clear) surgical scaffold. The subject device has the predicate device: soft tissue repair/reinforcement.

SurgiLattice™ scaffold is indicated for use as a bioabsorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. SurgiLattice scaffold is also indicated for the repair of hernia and other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

SurgilLattice scaffold is a bioabsorbable surgical mesh manufactured from poly-butylene succinate (PBS). PBS is an absorbable polymer that is processed into monofilament fibers and knitted into a surgical scaffold. PBS degrades through the process of hydrolysis, is absorbed over time, and is ultimately eliminated as CO2 and H2O. It has been developed to optimize absorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.

GalaSTITCH™ Absorbable Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.

GalaFORM 3D scaffold is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaFORM 3D scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.

GalaSHAPE™ 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE™ 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

GalaSHAPE 3D is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength over time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.

GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

GalaFLEX mesh is a sterile, knitted, resorbable mesh, constructed of non-dyed monofilament fibers made from poly-4-hydroxybutyrate (P4HB). It is provided in single sheets of varying widths, lengths and shapes, and may also be cut to the shape or size desired for a specific application.

TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

TephaFLEX suture is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB). The suture consists of an inner core of multifilament fibers covered by a braided sheath made of multifilament fibers. The suture is provided dyed (D&C Violet No. 2) or un-dyed and is offered in a variety of cut lengths, with or without needles attached.

TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX Meltblown Matrix is a resorbable construct prepared from poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed or dyed with D&C Violet No. 2. It is a porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric. It is provided in single sheets of varying widths, lengths and shapes ranging from 1x1 to 10x14 inches.

TephaFLEX light mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX light mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.

TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.