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MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.

The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.

The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style graft structure with the same underlay component as the predicate device, attached to an external stabilizing component with an absorbable knotted thread, all made from the same SIS (small intestinal submucosa) ECM material as that of the predicate device. This self-securing structure maintains the location and close tissue approximation of the underlay component across the tympanic membrane (TM) defect as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides longterm restoration and augmentation. Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.

SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period. The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.

The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.

ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour

ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.

The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.

The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.

PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery: As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation. PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.