dimecres, 27 de desembre del 2017

Zimmer Biomet touts pilot data for nStride knee injection

Zimmer BiometZimmer Biomet (NYSE:ZBH) last week touted data from a pilot study of its nStride autologous protein solutions kit for treating osteoarthritis of the knee.

The nStride APS kit allows surgeons to concentrate anti-inflammatory cytokines and growth factors from a patient’s blood sample, which are then injected into the knee. The 46-patient Progress II study randomized subjects to either a single nStride APS injection or a single saline injection. The study showed a 65% improvement in the WOMAC pain score for nStride APS patients, compared with a 41% improvement for the control arm. VAS pain scores improved 49% for the treatment arm compared with 13% for the control group; there were no procedure- or device-related serious adverse events and comparable adverse events in both arms.

“As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the management of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopedic disease,” group president David Nolan said in prepared remarks. “The positive results of the Progress II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nStride APS kit, but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.”

“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” added lead investigator Dr. Elizaveta Kon of Milan’s Humanitas University. “After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were pleased to demonstrate that APS, prepared with the nStride APS kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee.”

The post Zimmer Biomet touts pilot data for nStride knee injection appeared first on MassDevice.



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