Derma Sciences, Inc, Princeton, NJ, announced that it has obtained Food and Drug Administration clearance to market and sell its MOBILITY-1 boot and compressor device as a system for the treatment of chronic venous insufficiency, deep vein thrombosis prevention, venous ulcers, lymphedema, and other conditions that require compression therapy, including the enhancement of blood circulation during recovery from coronary artery bypass graft surgery and orthopedic hip and knee replacements.
Previously, the company had obtained clearance only for the sale of the compression boot. The additional clearance to sell the compressor will allow MOBILITY-1 to more effectively compete with other standard intermittent compression therapy devices that require an electronic compressor. MOBILITY-1, used as a system (the boot in conjunction with the electronic compressor), will provide significant benefits over competitive devices for patients who are ambulatory and do not want to be confined to their homes for therapy, according to the manufacturer.
Coloplast Corp, Minneapolis, MN, has signed an agreement with Carbon Medical Technologies, Inc, St. Paul, MN, giving Coloplast exclusive US distribution rights to Durasphere EXP injectable bulking agent and its needle delivery system. Durasphere EXP will be available from Coloplast starting in June.
Durasphere EXP, composed of pyrolytic carbon-coated beads suspended in a water-based carrier gel, is indicated for the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. It is injected to augment the soft tissue around the urethra to close the bladder neck and restore normal urinary control.
More than 15 million women in the United States suffer from SUI, and the number is expected to increase as the US population ages. An injectable urethral bulking agent can be used as an alternative to surgery for the relief of SUI symptoms.
Beiersdorf AG, Hamburg, Germany, recently signed an agreement to sell its US first-aid brand, Curad, to Medline Industries, Inc, Mundelein, IL. The nation's largest privately held manufacturer and distributor of medical supplies, Medline plans to incorporate the Curad line into its business. Beiersdorf pursued the sale as part of its strategy in the United States, which includes emphasizing skin care, under the Nivea and Eucerin brands, and the Futuro business.
LiquiCell Technologies, Inc, Minneapolis, MN, recently signed a licensing agreement with Integral Orthopedics, allowing Integral to use LiquiCell technology in its Moller Ortho-Pedic Seat, along with other select products. LiquiCell is an ultra-thin, liquid interface that combines a low viscosity fluid and strategically placed seal points that control the flow of liquid to equalize perpendicular pressure at the point of contact, reducing pressure, soft tissue compression, skin friction, and soft tissue shear stress. When used in the Moller Ortho-Pedic Seat, LiquiCell will help prevent fatigue and discomfort without interfering with patient positioning and stability.
Angiotech Pharmaceuticals, Inc, Vancouver, Canada, has received European approval for its Quill Self-Retaining System, a wound closure system with a helical barb design that allows surgeons to suture without using knots. Quill was launched in the United States early in 2007. The absence of knots provides the potential to improve patient outcomes by minimizing the complications associated with knots and potentially improving wound healing and enhancing cosmesis; the potential to save time in the operating room; and enhancing procedural techniques by allowing the closure of difficult wounds, suturing in tight places, and the surgeon to control tension.