Industry News
Microsize bladder device receives FDA IDE designation
StimGuard (Ft. Lauderdale, FL), a privately-held, precommercial stage medical device company, received US Food and Drug Administration Investigational Device Exemption approval to launch a clinical trial of the world’s first passive microsize implantable device for the treatment of overactive bladder syndrome, utilizing wireless technology and placed completely through a needle. The clinical trial will launch in summer 2015.
The device has just 1 implanted component: a microsize neurostimulator that can be implanted nonsurgically by using only a needle. A small external transmitter is easily and discreetly worn and attached to underwear and not directly in contact with the skin at anytime. With no internal batteries, the product’s wireless technology eliminates the need for extra surgeries to replace batteries or upgrade components and is compatible with MRI scans, unlike the existing commercial options.
The device utilizes Stimwave’s revolutionary electroceutical device — a tiny, injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves.
For more information, visit www.stimguard.com.
Certification category created for wound treatment associates
The Wound, Ostomy and Continence Nursing Certification Board (WOCNCB) created a certification category for wound treatment associates. The purpose of the wound treatment associate (WTA) certification is to identify nonspecialty nurses who have obtained the knowledge and skills necessary for competent practice as an associate in wound care. The Society’s WTA Program, developed in response to the growing demand for trained wound care providers, will play an integral part in the WTA certification process when it launches this fall.
The WOCN Society encourages WOC nurses to integrate WTA-certified nurses into their wound care teams and emphasizes the value of cooperation in clinical practice.
The application and testing period for candidates will open in the fall. To earn the WTA certification, a candidate must pass the WTA certification examination and meet all WTA eligibility requirements:
• Must have a current RN or LPN license
• Must have completed the WOCN Society’s WTA Program, under the direction of an approved board-certified WOC nurse and hold a WTA Program certificate of completion
• Must have completed 16 supervised clinical wound care hours.
Upon passing of the WOCNCB certification exam, the certified WTA nurse will be able to use the WTA-C credentials.
For more information, visit www.wocncb.org.
Amended agreement includes connective tissue matrix product
Alliqua Biomedical, Inc (Langhorne, PA) amended its exclusive licensing agreement with Celgene Cellular Therapeutics, a subsidiary of Celgene Corporation (Summit, NJ). Under the terms of the amended agreement, Alliqua has the right to develop and market Celgene Cellular Therapeutics’ connective tissue matrix product.
The connective tissue matrix product is derived from human placental tissue and will be made available by Alliqua when commercialized. It is currently indicated for the replacement or supplementation of damaged or inadequate integumental tissue, including podiatric and orthopedic applications, as well as homologous use in the management of acute and chronic nonhealing wounds. With the growing number of complex wounds and expanded orthopedic applications, a connective tissue matrix has the potential to benefit more than 1 million patients in the United States suffering from a wide array of wounds.
For more information, visit www.alliqua.com.
Device combines absorbent dressing with negative pressure
Acelity (San Antonio, TX) announced that Nanova Therapy System, a new absorbent dressing enhanced with negative pressure for slow-to-heal wounds, is now available exclusively in European markets. The disposable hand-activated unit can be used up to 30 days with multiple dressings, providing an easy-to-use, cost-effective way for clinicians to continue negative pressure wound therapy (NPWT) outside the hospital setting.
Weighing only 7.2 g, the unit can be carried in a pocket, will not impede patient mobility, and may enable an earlier return to daily activities. In addition, the dressing’s absorbent layer retains exudate, removing the need for a separate fluid reservoir. The dressing incorporates DermaTac Protective Seal Technology, providing an effective seal while enabling easy repositioning of the dressing as required. In the community setting, the dressing will continue to absorb exudate even in the absence of negative pressure.
For more information, visit www.nanovatherapy.eu.
Health economic benefits of bioengineered cellular technologies demonstrated
Findings from a groundbreaking study on the health economic benefits for Medicare patients receiving Apligraf and Dermagraft (Organogenesis Inc, Canton, MA) for the treatment of diabetic foot ulcers (DFUs) were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 20th annual meeting in Philadelphia, PA, May 16–20.
A presentation entitled Economic Outcomes Among Medicare Patients Receiving Bioengineered Cellular Technologies for Treatment of Diabetic Foot Ulcers revealed results from a study, generated in collaboration with a team of expert economists from Analysis Group, of more than 20,000 DFU patients from 2006 to 2012, which was recently published in the peer-reviewed Journal of Medical Economics.
Researchers compared real-world medical resource utilization, rates of lower-limb amputation, and Medicare costs associated with the use of the bioengineered living cellular technologies Apligraf and Dermagraft, relative to conventional care in DFU patients. The results demonstrated patients treated with these products had fewer costly health care services than DFU patients who underwent conventional care. Notable findings include:
• Apligraf patients had a 27.6% lower amputation rate, 33.3% fewer days hospitalized, and 32.3% fewer emergency department visits than their respective matched controls;
• Dermagraft patients had a 22.2% lower amputation rate, 42.4% fewer days hospitalized, and 25.7% fewer emergency department visits than their respective matched controls;
• The health care costs per patient for Apligraf and Dermagraft patients during the 18-month follow-up period were lower than their respective matched controls ($5,253 lower for Apligraf patients, $6,991 lower for Dermagraft patients).
Use of Apligraf or Dermagraft for treatment of DFUs was shown to improve patient outcomes with reduced incremental financial impact for payors.
For more information, visit www.organogenesis.com.
Incontinence care company partners with nonprofit for seniors
SCA (Philadelphia, PA), a leading global hygiene and forest products company and the maker of TENA incontinence and skin care products, is partnering with Wish of a Lifetime, a nonprofit organization committed to creating a cultural shift on how aging is viewed in the United States and celebrating the passions of seniors across the country. Together, Wish of a Lifetime and SCA will fulfill the lifelong wishes of 3 senior citizens who have overcome challenges in their lives. Brookdale, the nation's largest operator of senior living communities and longtime Wish of a Lifetime partner and SCA customer, will support the fulfillment of 2 of the 3 wishes.
The partnership kicked off May 15, with the first wish granted to Shirley Payne, a 90-year old resident of Kingstown, RI. An accomplished and compassionate senior and current resident of Brookdale's South Kingstown community, Shirley's Wish was to meet and sail with the women of Team SCA, the only all-female sailing team competing in the 2014-2015 professional Volvo Ocean Race, viewed as the most grueling sporting event in the world. In addition to meeting members of Team SCA, Shirley and her companion sailed around Newport Harbor while witnessing Team SCA in action competing in the inport Pro-Am race. Shirley celebrated her Wish with several fellow residents from her Brookdale community.
This summer, 2 additional senior women with a similar commitment to helping others and passion for adventure,will see their wishes fulfilled through this partnership.
For more information, visit www.tena.us.
Antimicrobial irrigation solution found for wound care
Anasept Antimicrobial Wound Irrigation Solution is a breakthrough in wound care. Based on Anacapa’s (San Dimas, CA) Anasept Antimicrobial Skin and Wound Cleanser, this antimicrobial irrigation solution provides a new dimension in wound care and negative pressure wound therapy (NPWT).
The US Food and Drug Administration-cleared antimicrobial solution contains a broad-spectrum antimicrobial sodium hypochlorite that inhibits the growth of antibiotic resistant strains such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococci, and carbapenem-resistant Escherichia coli, as well as fungicidal, sporicidal, and virucidal properties. The easy-to-use, spikable container with an integrated hanger that can be quickly attached to an IV pole or NPWT device can be used with most NPWT systems that are available with instillation or infusion capability.
The solution has undergone rigorous safety testing at an independent laboratory and shown to meet all criteria for safe use. In addition, it is clinically proven to reduce bioburden levels and improves the rate of healing. It is nonflammable and can be used safely in hyperbaric chambers. It remains stable for 2 years when maintained at normal room temperature.
For more information, visit www.anacapa-tech.net.
Nonadhesive foam dressing now available in Europe
Acelity (San Antonio, TX) announced that TIELLE Non Adhesive, a new and improved foam dressing, is now available in Europe and is the first in an enhanced range of TIELLE hydropolymer foam dressings incorporating new design and materials to better meet patient needs and help provide a comfortable and effective healing environment for all types of wounds.
The foam dressing is intended to manage a range of exudate levels while retaining more fluid than other foam dressings. The result is a cover dressing that is more comfortable and easier for a patient to wear. This polyurethane foam dressing can be cut to size and is designed to help maintain a moist wound healing environment through the combination of superior fluid handling, moisture vapor transmission, and flexibility. The design allows up to 7 days wear time without leakage, depending on the level of exudate. This may significantly reduce the number of dressing changes.
The dressing is composed of 3 layers: the original LiquaLock absorbent layer, which locks fluid away to reduce the risk of maceration and leakage, even under movement and pressure exerted by compression bandaging; a new superabsorbent layer that enhances fluid handling capacity; and a new highly breathable polyurethane film backing, which also works as a bacterial barrier. The new design and materials together maximize performance, leading to a 30% increase in total fluid handling capacity and a dressing 40% thinner than the previous version. Responding to customer feedback, the dressings are provided in transparent primary packaging to aid product selection.
For more information, visit www.Systagenix.com/TielleNA.
This article was not subject to the Ostomy Wound Management peer-review process.
