Bioresorbable Ear Packing and Patching Products
for Middle Ear Surgery and Other Otologic Procedures
for Middle Ear Surgery and Other Otologic Procedures
This website provides excerpts from our user manuals. It is important to consult the full system manuals for the most updated information.
MeroGel® Otologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process.
MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery.
MeroGel is contraindicated in patients with hypersensitivity to the product.
EpiFilm® Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.
EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures.
EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product.
EpiDisc® Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.
EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures.
EpiDisc is contraindicated in patients with hypersensitivity to the product.
The EpiDisc® TM Perforation Patch Kit is intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
The EpiDisc TM Perforation Patch Kit is indicated for use during myringoplastic surgical procedures.
EpiDisc TM Perforation Patch Kit is contraindicated in patients with hypersensitivity to the product.
The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. The physician must exercise medical judgement and consider the patient’s complete medical history. Medtronic Xomed ossicular prostheses are indicated for the functional restoration of sound energy conduction in the middle ear as reconstructive devicesor artificial replacement for the natural ossicles of the middle ear. Reconstruction or replacement of all or part of the ossicular chain may be necessary to correct structural damage of the middle ear ossiclesor conductive hearing loss resulting from a number of pathologic conditions, including but not limited to:
Certain conditions may preclude the selection of ossicular prostheses implants as a means of restoring conductive hearing loss including:
Surgery of the middle ear involves manipulation of fragile temporal bones and exposes inner ear structures to the risk of surgical trauma and infections. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing. Subsequent surgical procedures may be required to correct these conditions if possible.
Complications which may occur include, but are not limited to:
A high degree of surgical skill is required for the proper implantation of any ossicular prostheses. Surgeons performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of Medtronic Xomed ossicular prostheses. Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications.implant should be trimmed (or a shorter implant selected) if it is too long for the vestibule to avoid any contact with sensitive inner ear structures.
At a minimum, the following precautions must be taken:
Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. The following postoperative precautionary measures are recommended:
Hydroxylapatite is the basic inorganic constituent of living bone tissue. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. In the event that minor modifications of a dense H/A head or shaft are required, it is advisable to perform all trimming or contouring with a diamond burr using copious amounts of irrigation. Smooth, even brushing strokes should prevent inadvertent breakage. Reults, based on almost 10 years of clinical experience using dense hydroxylapatite in the middle ear, suggest that implants can be placed in direct contact with the tympanic membrane without the added risk of extrusion.
However,the use of cartilage or other suitable autogenous tissue as an interface between the implant and the tympanic membrane should be left to the surgeon’s experiences and preferences.
FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain.
The surgeon must use medical judgment and consider the patient’s medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but are not limited to:
Some conditions for which ventilation tubes may not be the therapy of choice include:
The Medtronic Xomed Activent® Antimicrobial Ventilation Tube was evaluated in a 12-month study in the middle ear of animals.1 While the Activent tube was formed of silicone and silver oxide and was shown to be bacteriocidal/bacteriostatic, the study showed that the material produced no significant adverse effects compared to silicone control material. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown.
Chole RA and Brummet RE, et al. Safety of silver oxide-impregnated Silastic tympanostomy tubes. Am J Oto. 1995; 16(6):722-724.