Ventris Medical's Innovative Backpack® Bone Graft Receives FDA Clearance for Spinal Procedures

In a significant advancement in orthopedic surgery, Ventris Medical has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative Backpack® Bone Graft. This new biomaterial is specifically designed for use in the intervertebral disc space, marking a milestone in tissue regeneration and orthobiologics. The Backpack® Graft aims to enhance cell proliferation and bone formation, which are crucial factors in effective orthopedic and spinal fusion procedures.

Understanding the Backpack® Bone Graft

The Backpack® Graft is available in two distinct versions, each tailored to optimize the conditions for bone healing. The first variant, known as Backpack® AF, utilizes a collagen mesh pouch that encases osteoinductive Allocell® AF fibers. This design not only contains the allograft fibers but also contributes to the bone remodeling process at the graft site. The inclusion of the 100% biologic graft system sets a new benchmark in the field, as both the pouch and the fibers work collaboratively to facilitate the natural healing process.

The osteoinductive properties of Allocell® AF fibers are particularly noteworthy, as they actively promote the differentiation of stem cells into bone-forming cells, thereby fostering enhanced bone regeneration. Designed with user convenience in mind, the Backpack® AF is offered in a ported pouch for easy hydration, simplifying the surgical process significantly.

The second version, Backpack® AMP, features surface-activated Amplify® granules which are also encased in a collagen pouch. This variant comprises a hybrid mixture of biphasic granules, each with varying resorption rates that nourish the fusion site during different healing stages. This bimodal dissolution profile supports both the immediate healing needs and ongoing bone remodeling, ensuring a more effective recovery for patients.

Comments from Leadership

Russell Cook, the CEO of Ventris Medical, expressed immense satisfaction regarding the FDA clearance for both Backpack® AF and Backpack® AMP systems. He remarked, “This graft containment technology is the first of its kind and represents a huge leap forward in bone graft technology available in today's market.” He emphasized the seamless integration of thoughtfully studied components, incorporating osteoinductive elements and patented surface-activated granules within a biologically compatible containment system.

Adding to this, John Brunelle, the COO, highlighted the importance of the Backpack® technology platform in enhancing surgical experiences and improving fusion outcomes. He mentioned that the sophisticated design allows for precise graft retention and delivery, ensuring that surgeons can achieve consistent healing responses at the fusion site. According to Brunelle, these advancements solidify Ventris Medical’s role as a key innovator in orthobiologics.

Commitment to Innovation

Ventris Medical continues to pave the way for next-generation medical devices aimed at transforming the surgeon's experience. Their mission is clear: to develop and innovate products that inspire confidence within the surgeon community and among distribution partners. The development of the Backpack® system represents just one aspect of their commitment to improving patient care through advanced medical solutions.

As Ventris Medical looks towards the future, the FDA clearance for the Backpack® Bone Graft not only validates their innovative approach but also opens doors for new product development opportunities in the orthobiologics sector.

With this groundbreaking technology, the company is set to make substantial contributions to the field of spine surgery and tissue regeneration, ultimately improving outcomes and enhancing the healing process for patients undergoing spinal procedures.

For more information about Ventris Medical and its innovative products, visit www.ventrismedical.com.