Here are five highlights:
1. IDRT will be used for the treatment of diabetic foot ulcers.
2. The approval of this new indication is based on results from the FOUNDER Study, a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption.
3. The study found that patients treated with IDRT demonstrated a 59 percent improvement in the incidence of complete wound closure compared to standard care.
4. According to Lawrence A. Lavery, DPM, FOUNDER Study principle investigator, 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.
5. Prevalence of diabetes continues to rise, currently affecting an estimated 30 million people in the United States. As many as 15 percent of those diagnosed may experience a diabetic foot ulcer in their lifetime.
More articles on devices and implants:
Vexim reaches 25k milestone for SpineJack units sold: 4 things to know
DanaMed and Stratasys Direct Manufacturing collaboration produce new ACL reconstruction tool — 5 things to know
FDA clears exports of MiMedx allografts — 4 highlights
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
