Sam Brusco, Associate Editor05.29.24
Medtronic has gained U.S. Food and Drug Administration (FDA) breakthrough device status for its Infuse bone graft with an intervertebral fusion device and commercially available metallic screw and rod system.
The designation specifically pertains to using Infuse in a transforaminal lumbar interbody fusion (TLIF) approach at one or two adjacent levels from L2-S1 to treat degenerative disease of the lumbosacral spine.
The company is enrolling patients in a prospective, randomized clinical trial of Infuse in a TLIF approach at one or two adjacent levels from L2-S1. The trial’s goal is to prove safety and effectiveness sufficient to expand indications in TLIF.
“We appreciate the FDA's recognition that Infuse has the potential to raise the standard of care in TLIF. With this designation, our goal is to broaden the availability of this established technology, reaching more patients affected by debilitating spine conditions,” said Michael Carter, VP and GM of Medtronic’s Spine and Biologics business. “By expanding access to Infuse, we aim to empower healthcare providers with effective tools to address the challenges posed by degenerative spine conditions. Ultimately, our mission is to enhance the quality of life for individuals suffering from these conditions, fostering a future where patients can enjoy improved mobility and comfort."
The Infuse bone graft has FDA approval for specific spin, oral-maxillofacial, and orthopedic trauma procedures. In spine surgery, it’s used with certain Medtronic interbodies for patients with degenerative disc disease.
“Over the past two decades, Infuse has become an important and trusted technology in modern spine surgery and Medtronic’s goal is to provide greater access for surgeons and patients,” said Dave Breiter, vice president of Regulatory Affairs, Clinical Research, Medical Science, and HEPR (Health Economics, Policy, and Reimbursement). “We are pleased to receive Breakthrough Device designation and look forward to continued collaboration with FDA as we broaden the clinical evidence regarding the safe and effective use of Infuse and pursue approval of new indications.”
The designation specifically pertains to using Infuse in a transforaminal lumbar interbody fusion (TLIF) approach at one or two adjacent levels from L2-S1 to treat degenerative disease of the lumbosacral spine.
The company is enrolling patients in a prospective, randomized clinical trial of Infuse in a TLIF approach at one or two adjacent levels from L2-S1. The trial’s goal is to prove safety and effectiveness sufficient to expand indications in TLIF.
“We appreciate the FDA's recognition that Infuse has the potential to raise the standard of care in TLIF. With this designation, our goal is to broaden the availability of this established technology, reaching more patients affected by debilitating spine conditions,” said Michael Carter, VP and GM of Medtronic’s Spine and Biologics business. “By expanding access to Infuse, we aim to empower healthcare providers with effective tools to address the challenges posed by degenerative spine conditions. Ultimately, our mission is to enhance the quality of life for individuals suffering from these conditions, fostering a future where patients can enjoy improved mobility and comfort."
The Infuse bone graft has FDA approval for specific spin, oral-maxillofacial, and orthopedic trauma procedures. In spine surgery, it’s used with certain Medtronic interbodies for patients with degenerative disc disease.
“Over the past two decades, Infuse has become an important and trusted technology in modern spine surgery and Medtronic’s goal is to provide greater access for surgeons and patients,” said Dave Breiter, vice president of Regulatory Affairs, Clinical Research, Medical Science, and HEPR (Health Economics, Policy, and Reimbursement). “We are pleased to receive Breakthrough Device designation and look forward to continued collaboration with FDA as we broaden the clinical evidence regarding the safe and effective use of Infuse and pursue approval of new indications.”