Integra LifeSciences Holdings Corporation01.11.16
The U.S. Food and Drug Administration (FDA) has approved the PMA Supplement for Integra LifeScience Holdings Corporation's Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFU).
The approval of this new indication is based on results from the FOUNDER (FOot Ulcer New DErmal Replacement) Study, a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The FOUNDER Study showed that patients treated with IDRT demonstrated a 59 percent improvement in the incidence of complete wound closure compared to standard of care. IDRT, with its newly approved DFU indication, will be marketed under the name Integra Omnigraft Dermal Regeneration Template.
"Integra is pleased to announce the approval of IDRT for the treatment of diabetic foot ulcers. This approval allows us to provide clinicians and their patients with a product backed by a clinical trial to treat the nearly 1 million non-healing DFUs that will occur this year. This significant milestone enables us to remain on track for DFU market commercialization in mid-2016," said Peter Arduini, Integra’s president/CEO.
The prevalence of diabetes continues to rise, currently affecting an estimated 30 million people in the United States, according to estimates. Of those diagnosed, as many as 15 percent may experience a diabetic foot ulcer in their lifetime. The advanced active healing dressings market is approximately $3 billion in the U.S., of which nearly $600 million is in cellular and tissue-based products (CTPs).
“The new indication for IDRT, supported by clinical evidence, will benefit clinicians and their patients. This product has been used in the operating room to treat life-threatening third-degree burns since 1996, and can now be used in the clinic to treat patients who suffer from diabetic foot ulcers,” said FOUNDER Study Principle Investigator Dr. Lawrence A. Lavery, D.P.M., M.P.H., of University of Texas Southwestern Medical Center.
The FOot Ulcer New DErmal Replacement (FOUNDER) Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an IDE. The pivotal clinical trial enrolled 307 patients at 32 sites, and patients were followed for up to 29 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks. The secondary outcome measures included time to complete wound closure, incidence of recurrence, and quality of life. The median number of applications per patient, including the initial application, for the IDRT group was one. The results from the FOUNDER Study were printed in the November/December issue of Wound Repair and Regeneration in the publication, "A Clinical Trial of Integra Template for Diabetic Foot Ulcer Treatment.”
Integra was founded on a technology platform to repair and regenerate tissue with engineered collagen devices. In 1996, the FDA approved the company's first product, Integra Dermal Regeneration Template, a collagen matrix designed as a skin replacement system for the treatment of third-degree burns. Integra Dermal Regeneration Template was the first product approved with a claim of regeneration of dermal tissue. Integra's skin and wound products also include Integra Meshed Bilayer Wound Matrix, which can be used with Negative Pressure Wound Therapy; and Integra Flowable Wound Matrix, designed for easy application to tunneled and/or undermined wounds. Together, these products represent over 30 years of science and innovation in the development of collagen technology. Integra's Ultra Pure Collagen is the base material of implants used successfully in more than 12 million procedures.
In July 2015, Integra acquired TEI Biosciences and TEI Medical, which added the SurgiMend and PriMatrix product lines to address a number of indications in wound care and tissue repair.
Integra Dermal Regeneration Template is an advanced skin replacement matrix, designed to provide immediate wound closure and permanent regeneration of the dermis. The product is placed in direct contact with the excised wound and consists of a complex three-dimensional porous matrix that acts as a scaffold for cell migration and allows for regeneration of the dermal layer of the patient's skin.
Based in Plainsboro, N.J., Integra LifeSciences develops regenerative technologies solutions, including those for specialty surgery, orthopedics and tissue technologies.
The approval of this new indication is based on results from the FOUNDER (FOot Ulcer New DErmal Replacement) Study, a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). The FOUNDER Study showed that patients treated with IDRT demonstrated a 59 percent improvement in the incidence of complete wound closure compared to standard of care. IDRT, with its newly approved DFU indication, will be marketed under the name Integra Omnigraft Dermal Regeneration Template.
The prevalence of diabetes continues to rise, currently affecting an estimated 30 million people in the United States, according to estimates. Of those diagnosed, as many as 15 percent may experience a diabetic foot ulcer in their lifetime. The advanced active healing dressings market is approximately $3 billion in the U.S., of which nearly $600 million is in cellular and tissue-based products (CTPs).
“The new indication for IDRT, supported by clinical evidence, will benefit clinicians and their patients. This product has been used in the operating room to treat life-threatening third-degree burns since 1996, and can now be used in the clinic to treat patients who suffer from diabetic foot ulcers,” said FOUNDER Study Principle Investigator Dr. Lawrence A. Lavery, D.P.M., M.P.H., of University of Texas Southwestern Medical Center.
The FOot Ulcer New DErmal Replacement (FOUNDER) Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an IDE. The pivotal clinical trial enrolled 307 patients at 32 sites, and patients were followed for up to 29 weeks. The primary endpoint of the study was the incidence of complete wound closure at 16 weeks. The secondary outcome measures included time to complete wound closure, incidence of recurrence, and quality of life. The median number of applications per patient, including the initial application, for the IDRT group was one. The results from the FOUNDER Study were printed in the November/December issue of Wound Repair and Regeneration in the publication, "A Clinical Trial of Integra Template for Diabetic Foot Ulcer Treatment.”
Integra was founded on a technology platform to repair and regenerate tissue with engineered collagen devices. In 1996, the FDA approved the company's first product, Integra Dermal Regeneration Template, a collagen matrix designed as a skin replacement system for the treatment of third-degree burns. Integra Dermal Regeneration Template was the first product approved with a claim of regeneration of dermal tissue. Integra's skin and wound products also include Integra Meshed Bilayer Wound Matrix, which can be used with Negative Pressure Wound Therapy; and Integra Flowable Wound Matrix, designed for easy application to tunneled and/or undermined wounds. Together, these products represent over 30 years of science and innovation in the development of collagen technology. Integra's Ultra Pure Collagen is the base material of implants used successfully in more than 12 million procedures.
In July 2015, Integra acquired TEI Biosciences and TEI Medical, which added the SurgiMend and PriMatrix product lines to address a number of indications in wound care and tissue repair.
Integra Dermal Regeneration Template is an advanced skin replacement matrix, designed to provide immediate wound closure and permanent regeneration of the dermis. The product is placed in direct contact with the excised wound and consists of a complex three-dimensional porous matrix that acts as a scaffold for cell migration and allows for regeneration of the dermal layer of the patient's skin.
Based in Plainsboro, N.J., Integra LifeSciences develops regenerative technologies solutions, including those for specialty surgery, orthopedics and tissue technologies.