Product News

Matrix Device Receives FDA Approval for DFUs

Integra LifeSciences Corp. (Plainsboro Township, NJ) has received U.S. Food and Drug Administration (FDA) approval for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers (DFUs). The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

An estimated 29 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and about 25% of them will experience a foot ulcer during their lifetime. Chronic DFUs are associated with tissue and bone infections and result in 50,000 amputations each year.

The FDA first approved the product in 1996 for the treatment of life-threatening burn injuries when the use of a patient’s own skin for a graft was not possible. In 2002, it was approved for a new indication to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts. Now, Omnigraft is approved to treat certain DFUs that last for longer than six weeks and do not involve exposure of the joint capsule, tendon, or bone, when used in conjunction with standard diabetic ulcer care.

Omnigraft’s new indication is based on a clinical study that demonstrated the matrix device improved ulcer healing compared to standard DFU care, which includes cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer. In the study, 51% of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32% of patients treated with standard DFU care alone. 

Visit www.integralife.com for more information.

Burns Treatment Device Granted Earlier Approval

Avita Medical Ltd. (Northridge, CA, and Cambridge, UK), a regenerative medicine company specializing in the treatment of wounds and skin defects, announced the U.S. Food and Drug Administration (FDA) has ruled the ReCell® Autologous Cell Harvesting Device eligible for earlier regulatory approval for burns treatment in the United States.

 The FDA’s Center for Biologics Evaluation and Research issued the designation and will now enter into further discussions with Avita to resolve a data development plan that will describe the extent of preclinical and clinical data required to support the premarket approval (PMA). A strategic data development plan, combined with priority review, is anticipated to underpin an earlier timeline. Avita is currently close to completing enrollment in its FDA-approval trial being conducted at seven of the nation’s leading burns centers, with 26 of the 30-patient target recruited. Prior to receiving the notice of expedited access pathway eligibility, the company estimated that regulatory approval would come in quarter three 2017, pending submission to the FDA of full safety and effectiveness data, under an application on the PMA regulatory route.

A series of 12 cases showed a 63% decrease in the length of hospital stay for patients living with extensive burn injuries when treated with ReCell.

The findings were presented at the 28th Annual Southern Region Burn Conference, held Nov. 20-22 in Dallas. The presentation, “The Use of ReCell in the Treatment of Large Burns: A Single Center Experience,” achieved second-place honors at the event.

 Visit avitamedical.com for more information. 

Cellular Bone Allograft Product Receives Patent

AlloSource® (Centennial, CO), a provider of cartilage, cellular, bone, skin, and soft tissue allografts for use in surgical procedures and wound care, has been awarded a patent for its regenerative medicine product AlloStem® Cellular Bone Allograft. The product is suitable for general bone grafting applications. AlloStem is similar to autograft bone because it provides the three key properties necessary for bone formation: scaffold, signal, and cells. The AlloStem patent is one of several in the growing portfolio of AlloSource living cell and tissue patents.

Visit www.allosource.org for more information.

Hemostatic Device Cleared for Cilivians

RevMedx, Inc. (Wilsonville, OR) received U.S. Food and Drug Administration (FDA) clearance for XSTAT,TM a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. The temporary device is for use of up to four hours until surgical care is acquired and is intended for use in the battlefield or with patients at a high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible junctional wounds when emergency department care is not readily available. 

The product works by injecting a group of small, rapidly expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the product’s sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. Each sponge contains an X-ray detectable marker to aid in surgical removal. XSTAT is not indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space above the inguinal ligament, or tissues above the clavicle.

Visit www.revmedx.com for more information.

Clinical Trials to Address Dialysis Patient Infections

RevMedx, Inc. (Wilsonville, OR) received U.S. Food and Drug Administration (FDA) clearance for XSTAT,TM a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. The temporary device is for use of up to four hours until surgical care is acquired and is intended for use in the battlefield or with patients at a high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible junctional wounds when emergency department care is not readily available. 

The product works by injecting a group of small, rapidly expanding sponges into a wound cavity using a syringe-like applicator. In a wound, the product’s sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. Each sponge contains an X-ray detectable marker to aid in surgical removal. XSTAT is not indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space above the inguinal ligament, or tissues above the clavicle.

Visit www.revmedx.com for more information.

Cover Dressing Reduces Joint Replacement Surgery Complications

The results of a randomized, controlled trial found the use of AQUACEL® Ag SURGICAL Cover Dressing (ConvaTec, Deeside, Flintshire, UK) resulted in a significant reduction in wound complications and dressing changes. The study also showed improved satisfaction in patients undergoing total joint arthroplasty as compared to the use of a standard gauze surgical dressing. 

In the trial, 262 patients were randomized to receive either AQUACEL Ag SURGICAL Cover Dressing or a standard gauze surgical dressing following knee or hip replacement surgery. Results of the trial were published in the American Journal of Orthopedics.