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New Products and Industry News
Moisture barrier ointment stays in place, protects skin
Coloplast Corp. (Marietta, Ga) introduces Critic-Aid Clear®, a clear moisture barrier ointment, and Critic-Aid Clear AF®, a clear antifungal moisture barrier ointment with 2% miconazole nitrate.
The barrier ointment sticks to intact as well as wet, denuded skin, protecting perineal skin from moisture while allowing the clinician to inspect the skin’s condition. This helps healthcare institutions maintain the bottom line by eliminating the necessity for multiple products.
The barrier ointment is available in 2.5- and 2-oz sizes and the antifungal barrier is available in 5- and 6-oz sizes. The products are also available in single-use packets.
For more information, call (800) 533-0464.
Licensing agreement for absorbent antimicrobials transferred
Smith & Nephew Inc. (Largo, Fla) announces that effective April 1, 2006, US marketing rights for the Iodosorb ™ and Iodoflex™ brands will transfer from Healthpoint (Fort Worth, Tex) to Smith & Nephew Wound Management.
Smith & Nephew currently owns and markets the products outside of the US. For the past 10 years, Healthpoint has had exclusive marketing rights in the US. With this transfer, Smith & Nephew will consolidate exclusive rights to market these brands worldwide.
The products are indicated for use in cleaning wet ulcers and wounds such as venous stasis ulcers, pressure ulcers, and infected wounds. Iodosorb assists in protecting the wound area and reducing microbial load in the wound environment. The products also help deslough and absorb exudate from wet wounds and ulcers.
Customers will continue to receive the same product with the same indications with no changes to the ingredients, the manufacturing process, or the product performance. The packaging will be changed only to reflect the new corporate branding and new product codes.
Orders for these products will continue to be processed by Healthpoint until March 31, 2006.
For more information, please call (800) 876-1261.
Diabetic foot ulcer trial produces favorable results
Cytomedix Inc. (Rockville, Md) announces that the audit of its clinical investigational sites and trial results for diabetic foot ulcers has been completed. The company undertook this audit with the assistance of an independent consultant, a former US Food and Drug Administration (FDA) branch chief responsible for bioresearch monitoring.
During the audit, it was discovered that some investigational centers had enrolled patients who did not meet the inclusion criteria or were not given treatment according to the study protocol. The trial yielded 40 patients after correcting for these types of deviations.
Of the 40 patients, 35 (88%) had wounds ≤7 cm2 in area and 2 cm3 in volume. The healing rates for these wounds in the AutoloGel™ group and control group were 81.3% and 42.1%, respectively. The control group was treated using an FDA-approved saline gel for use in wound treatment.
In the overall cohort of 40 patients, 68.4% treated with the wound gel healed to full wound closure and 42.9% of patients in the control group achieved full wound closure.
For more information, please call (240) 499-2680 or visit https://www.cytomedix.com.
CMS approves reimbursement code for NPWT device
BlueSky Medical (La Costa, Calif) has received reimbursement approval from the US Centers for Medicare and Medicaid Services (CMS) under HCPCS code E2402 for the Versatile 1® Wound Vacuum System.
Negative pressure wound therapy (NPWT) is used to treat chronic, non-healing wounds. The company is the second manufacturer to receive CMS coding for NPWT, now giving caregivers and patients a choice in treating wounds.
The company continues to expand national coverage through added dealer networks, national chains, GPOs, and strategic partnerships that will provide the necessary training and support to the marketplace.
For more information, please visit https://www.blueskymedical.com or https://www.npwt.com.
