• BioniCare Medical Technologies (Sparks, Maryland) said the FDA issued documents making official changes in response to the company's request for a clarification of classification for its pulsed electrical stimulator technology. The new classification will be “Transcutaneous Electrical Stimulator for Arthritis.” BioniCare has a distinct FDA labeling for both osteoarthritis of the knee and rheumatoid arthritis of the hand based on the clinical studies, yet it had been classified as a TENS based on the similar safety profile. The FDA revised all clearances for BioniCare. This change in product code will apply retroactively to BioniCare's OA Knee Device and RA Hand Device. The news follows Medicare's creation of a new product code, E0762, as a result of BioniCare's application submission last year.

• Ceragenix Pharmaceuticals (Denver) reported that the FDA's Office of Combination Products, in response to the company's formal request, has determined that Cerashield's primary mode of action is that of a device and it has been assigned to the FDA's Center for Devices and Radiologic Health for lead review through the premarket approval process. Cerashield, an absorbent foam dressing that contains the antimicrobial agent Ceragenin, is intended to be used as an antimicrobial wound dressing to help prevent bacterial colonization and infection at the site of catheter and other indwelling medical device insertions into the body.

• Clearant (Los Angeles) said that results from a study examining the safety and biomechanical integrity of tissue sterilized with the Clearant Process were published recently in the Journal of Orthopaedic Research. The study concluded that the Clearant Process method of terminal sterilization – gamma irradiation (50kGy dose) under controlled conditions and following a treatment with radio-protective solution – can virtually eliminate infections risks associated with soft tissue allografts while maintaining the pre-implantation biomechanical performance of the tissue. “In this study, we've demonstrated that tendon allografts irradiated under the specific conditions of the Clearant Process actually do deliver sterile implants that exhibit favorable biomechanics. The development of such a sterilization method that does not adversely affect tissue function provides added safety to tissues for transplantation,” a study author commented.

• Dale Medical Products (Plainville, Massachusetts) reported the introduction of a new endotracheal tube holder that secures and stabilizes the tube, is comfortable for the patient to wear, and provides easy access for tube rotation and oral care. The Dale Stabilock Endotracheal Tube Holder stabilizes 7 mm to 10 mm tubes following intubation to help prevent extubation, especially during patient transport. Featuring a protective barrier wipe and a latex-free, breathable fabric base, which securely holds a cushioned neckband using a velcro closure, it has a flexible tubing channel that protects the tube and permits easy access for repositioning and oral care. The Dale Stabilock Endotracheal Tube Holder is designed for single patient use, can remain comfortably in place up to three days and fits most adults.

• Endo Pharmaceuticals (Chadds Ford, Pennsylvania), the pain management subsidiary of Endo Pharmaceuticals Holdings, reported the commercial availability of Synera (lidocaine 70 mg and tetracaine 70 mg), a topical anesthetic patch. The company said Synera is the first self-contained topical patch for prevention of pain associated with superficial venous access and superficial dermatological procedures in patients three years of age and older. Effective immediately, Endo will begin marketing the Synera patch in the institutional setting through its existing 70-person hospital sales force.

• Exactech (Gainesville, Florida), a developer of bone and joint restoration products, reported that the FDA has cleared for distribution the only pre-formed cement shoulder spacer containing antibiotic available in the U.S. The InterSpace Shoulder, used to treat infected total shoulder arthroplasty, provides for consistent and uniform antibiotic release into the local infected area, confers mechanical advantages by maintaining the joint space, and offers patients mobility during the interval of spacer management and the opportunity for improved function following the definitive second-stage operation.

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