New Products and Industry News

Prescription wound care products introduced

Oculus Innovative Sciences, Inc (Petaluma, CA) introduced two new products to its United States family of Microcyn-based advanced wound care products. Microcyn Wound & Skin Spray HydroGel now comes in a sprayable formulation, allowing it to be easily and conveniently sprayed directly onto the wound site. Available in a 3-oz spray bottle, this newest advance in hydrogel technology is reimbursable via HCPCS A6248. Microcyn Wound & Skin Care with preservatives is available for the first time in a multi-use 2-oz spray bottle. Used to cleanse, irrigate, and aid in the debridement of a vast array of chronic and acute wounds, this product can be used before application of a variety of wound healing products and methods, including products with silver, enzymatic debriders, growth factors, tissue-engineered products, and dermal substitutes. The reduced bottle size allows use in the clinic, as well as economically dispensed or prescribed for patients’ in-home use.

For more information, visit www.oculusis.com.

510(k) clearance granted for incontinence device

The Food and Drug Administration has green-lighted the American Medical Systems (Minnetonka, MN) RetroArc Sling System for the treatment of female incontinence due to urethral hypermobility or intrinsic sphincter deficiency. The 510(k) clearance was granted November 21.

The sling consists of a mesh, an adjustment suture, and delivery needles with conical tips that provide smooth needle passage without deflection and flexing. The needles also can curve up to 110˚, allowing them to easily follow the trajectory of the pubic bone. The ergonomic quick-release handle was designed according to physician feedback for comfort of use.   The sling rounds out the company’s product line of devices to treat benign prostatic hyperplasia, incontinence, sexual dysfunction, and pelvic disorders in men and women.

For more information, visit americanmedicalsystems.com.

Single patient-use NPWT system launched

Mölnlycke Health Care (Norcross, GA) strengthened its negative pressure wound therapy (NPWT) offering by launching Avance Solo, a single patient-use, true NPWT system with variable pressure settings, across the United Kingdom.

Designed by Mölnlycke Health Care’s collaboration partner within NPWT, Medela AG, the system weighs 400 g, making it both easy to use and portable. It can be carried or worn in a discreet manner, giving patients greater flexibility, mobility, and comfort. With this system, patients can be discharged quickly from the hospital, continuing their treatment at home for up to 60 days. These features help improve efficiencies for both patients and healthcare providers when compared to using larger, less mobile negative pressure systems.

For more information, visit www.molnlycke.com.

Patient enrollment in DFU study complete

Integra LifeSciences Holdings Corporation (Plainsboro, NJ) has completed patient enrollment in a multicenter, randomized, controlled clinical trial comparing the safety and effectiveness of Integra® Dermal Regeneration Template to the standard of care for the treatment of diabetic foot ulcers (DFUs). This template is an advanced bilayer skin replacement system designed to provide immediate wound closure and permanent regeneration of the dermis.

The pivotal trial enrolled 307 patients at 32 sites, and all patients are followed for up to 28 weeks. Once patient follow-up is complete, which is expected to occur in mid-2014, the resultant data will form the foundation for submission for Premarket Approval (PMA) from the United States Food and Drug Administration (FDA). PMA, along with publication of the data in a peer-reviewed journal, will support reimbursement for the product.

For more information, visit www.integralife.com.

Systematic literature review throws doubt on wound care treatments

A systematic review of the literature focused on the treatment of skin ulcers suggests that most relevant research papers are so technically flawed their results are unreliable. Of those that do pass muster, evidence is weak that some treatments work better than standard compression therapy or special stockings for venous ulcer care.

In 2011, the Agency for Healthcare Research and Quality awarded the Johns Hopkins Evidence-Based Practice Center a $475,000 project to carry out the research, to be led by Gerald Lazarus, MD, founder of the Johns Hopkins Wound Healing Center and Professor of Dermatology and Medicine at Johns Hopkins Bayview Medical Center; and Jonathan Zenilman, MD, Scientific Director of the Wound Healing Center, Professor of Medicine, and Chief of the Division of Infectious Diseases at Johns Hopkins Bayview. The Johns Hopkins researchers enlisted input from a panel of 14 experts in wound care in their review of the data.

  The review identified 10,066 citations possibly related to wound care; 66 were found to specifically address questions regarding the effectiveness of treatments for chronic venous leg ulcers. Investigators analyzed clinical outcomes involving wound dressings, antibiotics, and venous surgery. Overall results found dressings that used living human cells increased wound healing. Results suggested that cadexomer iodine and collagen also may increase healing. Providing surgical treatments such as radiofrequency ablation, endovenous laser treatment, and sclerotherapy helped healing, and surgical correction of underlying pathology decreased recurrence of ulcers. However, evidence is inconclusive about using systemic antibiotics without demonstrated signs of infection.

For more information, visit www.hopkinsmedicine.org.

This article was not subject to the Ostomy Wound Management peer-review process.