Westaim Biomedical Corporation, Exeter, NH, has received Food and Drug Administration clearance to market over-the-counter silver-based antimicrobial bandages for consumer use. The bandages will be a lower-dose version of Westaim Biomedical's Acticoat burn and chronic wound dressings and will be developed for the local management of superficial wounds, abrasions, lacerations, and minor burns. Acticoat products are effective against more than 150 pathogens, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus. The company estimates that the product will be on the market in 2 years.
Pharmacia Corporation, Peapack, NJ, has received approval from the Food and Drug Administration to market Detrol LA (tolterodine tartrate extended release capsules), a once-daily therapy for the treatment of overactive bladder with symptoms of urinary urge incontinence, urgency, and frequency.
In the largest placebo-controlled study ever conducted for overactive bladder, more than 1500 men and women participated in this multinational trial conducted at 167 centers. After 12 weeks of treatment, more patients taking once-daily Detrol LA (4 mg daily) reported improvement than patients treated with placebo, including statistically significant improvements for incontinence episodes and decreases in urinary frequency compared with placebo. Patient perception of urgency also showed improvement from baseline with treatment.
The most common adverse events reported by patients treated with Detrol LA were dry mouth (23%), headache (6%), and constipation (6%). Dry mouth was reported by 23% of patients treated with Detrol LA vs 8% by patients treated with placebo. A total of 2.4% of patients treated with Detrol LA and 1.2% treated with placebo discontinued treatment because of adverse events and reported dry mouth.
Vacuum Assisted Closure (VAC) therapy, developed by KCl, Inc, San Antonio, TX, has been approved by the Health Care Financing Administration for a new Medicare Part B reimbursement code. The approval became effective on October 1, 2000, and applies to the VAC and the MiniVAC.
Clinical studies have shown that VAC therapy can promote wound healing, including healing of wounds that have resisted multiple medical interventions. VAC therapy was first cleared by the Food and Drug Administration in 1995 and is used to help treat diabetic ulcers, pressure ulcers, dehisced surgical incisions, flaps, grafts, traumatic wounds, and other nonhealing wounds. Prior to this approval, patients could receive VAC therapy only if they had private insurance that covered it or were able to pay for it on their own.
The Durable Medical Equipment Regional Carriers (DMERCs) have amended the monthly utilization guidelines in their Medicare ostomy policy to increase the maximum number of items a patient may use in a month. Included in the new guidelines are increases for drainable pouches (up to 20 per month), urinary pouches (up to 20 per month), closed pouches (up to 60 per month), irrigation sleeves (up to 4 per month), solid skin barriers and skin barriers with flange (up to 20 per month), and a new provision for 1 ostomy belt per month.
The policy restrictions on the medical necessity of closed pouches have been rescinded.
Documentation is needed in the patient's medical record to support the type and amount of supplies ordered. This is particularly important when the patient's needs are greater than the "usual maximum quantity" for the type of supplies that he or she uses.
Changes in the policy are effective for claims with dates of service on or after October 1, 2000.
Curative Health Services, Hauppauge, NY, has completed the sale of its Procuren operations to Cytomedix, Inc, Deerfield, IL. Under the agreement, Cytomedix acquires Curative's assets associated with Procuren operations and becomes the exclusive manufacturer of Procuren Solution, a wound-healing agent. Curative will retain exclusive distribution rights over Procuren Solution within the United States and will receive royalties based on the sales of products developed from the associated patents.
First Scientific, Inc, Ogden, UT, will now supply its skin protection formula in the form of towelette packets to ConvaTec, a Bristol-Myers Squibb Company, Skillman, NJ, to be incorporated into ConvaTec's comprehensive system of wound and skin care products. First Scientific's formula brings together dimethicone with skin conditioning emollients and botanical oils to create a solution for the treatment and prevention of rashes. The product is especially suited for bedridden patients and adults suffering from rash and skin irritation due to incontinence.
Hollister, Incorporated, Libertyville, IL, has developed a Continence Awareness Program (CAP) to educate the public about treatment options for incontinence. The message of the program is that incontinence not only affects a person's health-possibly resulting in urinary tract infections, skin breakdown, hip fractures, and avoidable hospital admissions-but it also affects overall quality of life. Many treatment options are available, and most people with incontinence can be helped with behavioral, surgical, or pharmacologic treatments, either alone or in combination.