#United States #Newport Beach #Ventris Medical #Bone Graft #Backpack System

Ventris Medical's Groundbreaking Backpack® Bone Graft Containment System

Ventris Medical, a pioneering company in the fields of orthobiologics and tissue regeneration, has announced a significant advancement in surgical treatments for bone injuries and disorders. The United States Food and Drug Administration (FDA) has granted 510(k) clearance for their innovative Backpack® Bone Graft Containment System. This approval marks a pivotal moment in the evolution of biomaterials aimed at optimizing cell proliferation and bone formation during orthopedic and spinal fusion procedures.

The Backpack® system stands out due to its unique features. Comprised of two distinct versions, the system is designed to enhance the healing process by utilizing proprietary components. One version incorporates a collagen mesh pouch filled with Allocell® AF fibers, while the other contains surface-treated Amplify® granules. Both versions are engineered for effective autologous bone grafting, promoting natural healing and bone growth.

A Closer Look at the Two Versions

• - Backpack® AF: This variant consists of a collagen mesh pouch enclosing osteoinductive allograft fibers. The first of its kind, this biologic graft system ensures that both the pouch and the allograft fibers actively contribute to bone remodeling at the surgical site. The Allocell® AF allograft has a scaffold-like structure that facilitates the attachment and proliferation of bone cells, thereby expediting the natural healing process. The inherently osteoinductive properties of the fibers encourage the differentiation of stem cells into bone-forming cells, resulting in enhanced bone regeneration capabilities. With a ported pouch designed for easy hydration, Backpack® AF is ready for use, simplifying surgical procedures.

• - Backpack® AMP: This version features a similarly designed collagen pouch, but it is filled with biphasic Amplify® granules. These surface-activated granules are created from a blend of two different ratios of hydroxyapatite (HA) to beta-tricalcium phosphate (βTCP) granules, promoting a controlled resorption rate. The unique bimodal dissolution profile nourishes the fusion site effectively during the critical early stages of healing, supporting ongoing bone remodeling throughout the surgical recovery process.

Implications for the Medical Community

Russell Cook, the CEO of Ventris Medical, expressed enthusiasm regarding the FDA clearance, stating, “This graft containment technology is a first in the industry and represents a major advancement in the field of bone graft technology.” The Backpack® system uniquely combines osteoinductive allograft fibers with patented materials in a biologic containment system that prevents unwanted migration. This offers surgeons a reliable tool for improving patient outcomes in fusion surgeries.

Dr. John Brunelle, COO of Ventris Medical, also highlighted the impact of this technology on the surgical experience, asserting that the system provides precise delivery and retention of clinically validated components, ensuring a more consistent healing response. The successful clearance of the Backpack® system underscores Ventris Medical’s commitment to innovation in orthobiologics, positioning the company as a leader in developing next-generation medical devices.

About Ventris Medical

Ventris Medical is dedicated to enhancing the field of medical devices, focusing on proprietary technologies that improve tissue regeneration and produce bioresorbable bone graft products applicable to various orthopedic and spinal fusion procedures. For more information about Ventris Medical and the Backpack® system, visit their official website at www.ventrismedical.com. The approval of the Backpack® Bone Graft System exemplifies the potential for improved surgical methods and patient rehabilitation in orthopedic care, paving the way for future innovations in the medical device landscape.