Cath Lab Digest

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Regenerative tissue matrix technology licensed
  KCI (San Antonio, TX) forged an agreement, effective imediately, to license Wright Medical Group, Inc.’s (Arlington, TN) GRAFTJACKET® brand for use in marketing the LifeCell™ acellular human dermal-based regenerative tissue matrix. The matrix is indicated for repair or replacement of damaged or inadequate integumental tissue, such as diabetic ulcers, or for other homologous uses of human integument. Proprietary processing allows the body to accept the matrix, reducing the potential for a rejection response. The matrix provides immediate coverage to the wound and is repopulated with the patient’s own cells and revascularized by the body, acting as a scaffold to convert the matrix to functional host tissue in ulcer repair. The matrix can be used as part of the overall treatment regimen in a variety of care settings.

  KCI now can offer both negative pressure wound therapy (NPWT) and regenerative tissue matrix for the treatment of hard-to-heal wounds across the care continuum. The matrix may be used in conjunction with NPWT. Clinical studies have shown the matrix provided a higher probability of healing when used as part of the standard treatment regimen; most diabetic foot ulcers can be treated successfully with one application of the matrix. The matrix is covered by many insurers, including Medicare.

  KCI’s Active Healing Solutions™ business unit will sell the regenerative tissue matrix under the GRAFTJACKET® brand name. During the next 6 months, Wright will transition out of its wound care sales of the matrix as KCI increases its sales and marketing of the product.

  For more information, visit www.kci1.com.

Second-generation bioengineered wound care alternative in production
  Aubrey Inc (Carlsbad, CA) announced that after a successful soft release and product evaluation phase of its second-generation product, AWBAT® Plus, the product is now in full production and currently available for purchase. The product not only utilizes the same patented technology for the precision-porous silicone-nylon membrane as the platform product, AWBAT®, but also contains significantly more collagen and chondroitin-4-sulfate, chondroitin-6-sulfate, vitamin C, vitamin E, and Immuno-10 (activated mixture of polysaccharides from aloe). The FDA determined this to be a combination product consisting of device components as well as drugs. In subsequent laboratory testing, immuno-10 was found to stimulate human dermal fibroblast proliferation, as well as fibroblast collagen and alpha-SMA production. Human keratinocyte production also was enhanced by immuno-10. The product currently is indicated for partial-thickness burns, meshed autografts, and donor sites. The company intends to seek clearance for use of the product on chronic wounds this year.

  For more information, visit www.aubreyinc.com.

Wound care dressings secure reimbursement codes
  PolyRemedy (Boston, MA), a provider of personalized wound care systems, has announced the Centers for Medicare and Medicaid Services (CMS) confirmed reimbursement codes for its customized antimicrobial dressings. Customized dressings comprise the therapeutic portion of the company’s integrated Personalized Woundcare System (PWS™), which also includes expert, protocol-driven wound assessment and dressing selection tools, as well as real-time feedback and alert notification throughout the wound healing process. The CMS confirmed coding for the PolyFIT™ Antimicrobial Dressings that promote an optimized wound healing environment without causing resistance to specific bacteria. Embedded with a 0.3% concentration of polyhexamethylene biguanide (PHMB), the dressings are designed to manage wound exudate and microbial proliferation within the dressing while maintaining a moist wound environment.