Search Results

BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.

The Laryngeal Augmentation Implant is a flexible, resorbable implant used as a space filling material for soft tissue augmentation. The Laryngeal Augmentation Implant is placed via percutaneous injection under local anesthesia with direct visualization via nasopharyngoscope. The ability to place the implant without open surgery offers both safety and convenience to the surgeon and patient. The system is designed to resorb with eventual in-growth of surrounding tissue. Every component of the implant has a minimum of twenty years use as a biomaterial.

BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: - · Periodontal Defects - · Ridge Augmentation - · Extraction Sites - · Craniofacial Augmentation - · Cystic Defects

Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.

Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.

The Coaptite™ Laryngeal Augmentation System consists of a single use, nonpyrogenic, space-occupying implant contained in a prefilled syringe with an injection needle for laryngeal vocal fold augmentation and medialization. Coaptite™ is available in 1.0cc syringes that are filled with either 1.0cc or a 0.5 cc volume. Coaptite™ contains calcium hydroxylapatite (Cas(PO4)3OH)2 particles (75-125 microns) suspended in a gel of USP glycerin, sterile water for injection and sodium carboxymethylcellulose (NaCMC). The calcium hydroxylapatite meets ASTM F1185. The excipients glycerin, sterile water, and NaCMC are both pharmaceutical USP grade and listed as GRAS. Calcium hydroxylapatite is radiopaque. The properties of Coaptite™ facilitate ingrowth of surrounding tissue-over time. The implantation procedure uses direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope.

Coaptite™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Coaptite™ Tissue Marker is a sterile, nonpyrogenic, flexible, semi-solid, cohesive implant used as a single use tissue marker. The principle component of the Coaptite™ Tissue Marker is synthetic calcium hydroxylapatite, a radiopaque biomaterial with over twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology, and ophthalmology. The product is available in two particle size ranges to allow different needle sizes for percutaneous placement. Coaptite™ Tissue Marker (0008025-1 and 0008026-1) has a size range of 75-125 microns. Coaptite™ FN Tissue Marker (0008027-1 and 0008028-1) has a size range of 25-45 microns. The calcium hydroxylapatite beads are clearly visible on standard radiographs as well as CT scan, MRI, and ultrasound. The cohesive semi-solid, elastic nature of the Coaptite™ Tissue Marker is created by physical bonds formed with sodium carboxymethylcellulose (NaCMC). NaCMC has also been used safely as a biomaterial for over twenty years. Coaptite™ Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. There is no ferrous material used in the formulation for Coaptite™ Tissue Marker and therefore it is MRI compatible.