Product News

AlloSource Releases New Product to AlloFuse Line

AlloSource (Centennial, CO), one of the nation's largest providers of cartilage, bone, skin, soft tissue, and cellular allografts for surgical procedures and wound care, has announced the release of AlloFuse^® Select CM to its AlloFuse portfolio.

AlloFuse Select CM combines osteoconductive, osteoinductive, and osteogenic properties to initiate and nurture bone growth, delivering the benefits of autograft bone without the potential drawbacks, officials said. The product is clinically proven to activate and support bone formation, and can be used in a variety of spinal, neurologic, and orthopedic procedures, according to officials. This cellular allograft matrix is also said to have good handling characteristics, as it is moldable and compressible for insertion into interbody implants or placement around anatomical structures. "AlloFuse Select CM underscores our commitment to offering surgeons the advanced solutions they need to support their patients' healing," said Kerr Holbrook, chief commercial officer at AlloSource. "Our passion for our donors and recipients is reflected in the continued expansion of the regenerative therapies we provide." The addition of AlloFuse Select CM enhances the AlloFuse portfolio of demineralized bone fiber, putty, paste, and gel allografts, officials said. This line expansion provides surgeons with a premium AlloSource cellular allograft to meet a variety of needs for patients.

VA Updates Supply Schedule, More Patients to Access TheraSkin

An update to the federal supply schedule by the Department of Veterans Affairs (VA) will reportedly result in nearly 9 million veterans having access to all four sizes of TheraSkin,^® a biologically active, cryopreserved human skin allograft for chronic wounds distributed by Soluble Systems, LLC (Newport News, VA).

"We are especially proud to offer two additional sizes of TheraSkin to the doctors and nurses treating our nation's veterans suffering with chronic wounds at the VA hospitals and outpatient centers," said Allan Staley, chief executive officer of Soluble Systems. "Whether the wound is large or small, clinicians and veterans can know that they have more options available to them with proven clinical evidence to back it up." TheraSkin is reportedly one of the fastest growing products in the living skin substitute market. A retrospective clinical study of 188 consecutive patients published in Foot & Ankle Specialist demonstrated healing rates of more than 60% at 12 weeks and 74% at 20 weeks for both diabetic foot ulcers and venous leg ulcers, according to Soluble Systems officials.

Acelity Launches Single-Use NPWT System for Simultaneous Incisions

Acelity (San Antonio, TX), a global advanced wound care company, has announced the availability of the PREVENA DUO™ Incision Management System to physicians in the United States. PREVENA DUO is the first single-use negative pressure wound therapy (NPWT) system designed specifically for the simultaneous management of two closed surgical incisions, according to company officials. “We are finding that surgeons around the world are adopting PREVENA™ Therapy as standard practice to provide care for their postoperative patients,” said Ron Silverman, MD, chief medical officer of Acelity. “With the introduction of the PREVENA DUO Platform, Acelity is able to provide the same proven clinical benefits of [NPWT] that is specially configured for procedures where there are two closed incisions on the patient.” According to one study led by Tim Matatov, MD, Louisiana State University Health Sciences Center, evaluating the PREVENA Incision Management System in reducing the risk of groin wound infection after vascular surgery, PREVENA Therapy was found to reduce the incidence of groin wound infection compared to traditional skin adhesive or absorbent dressings (6% incidence of infection with PREVENA Therapy compared to 30% with control group). The results also indicated significant cost savings with the PREVENA Incision Management System. In fact, the study authors concluded that the cost of the PREVENA System was quickly exceeded by the traditional dressings group due to long hospitalization required for two patients living with Szilagyi Grade III infections.

“Until now, clinicians did not have the option to manage two incisions simultaneously with a single, disposable negative pressure source,” said Silverman. “The new PREVENA DUO Platform offers one efficient, easy-to-use method for providing therapy to these patients.”

The PREVENA System, launched in 2010, is the first disposable NPWT specifically for the management of closed surgical incisions. The system covers and protects the incision from external contamination while negative pressure removes fluid and infectious material from the surgical incision.

Wound Matrix Product Gets FDA Clearance

Acera Surgical Inc., a bioscience company located in St. Louis, MO, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Restrata™ Wound Matrix product. Restrata is a fully synthetic electrospun wound dressing composed of randomly oriented nanofibers that create a highly porous scaffold for cellular infiltration and vascularization during wound repair, according to officials. Its structure was engineered to be similar to that of native extracellular matrix, one of the key building blocks of newly forming tissue.

“In pre-clinical testing, our product showed promising results compared to commercially available wound matrices,” said Tamas Kovacs, senior director of product management at Acera. “Acera’s scaffold allowed for the rapid formation of healthy, vascularized granulation tissue and effective wound closure with minimal inflammatory response. We’re excited to provide an alternative solution in wound healing that has potential to address many of the shortcomings of biologic products.”