Medtronic's Infuse™ Bone Graft Receives FDA Breakthrough Device Designation for TLIF Procedure

May 30, 2024 19:26 CST Updated 19:26

Medtronic

Medical Device Manufacturer

Source: Bone Future; Editor: Sophia

Reprint Requirements: You can directly repost, but please credit the source at the beginning of the article.

On May 29, 2024, Medtronic, a global leader in medical technology, announced that the companyInfuse™ Bone Graft ProductsHas Obtained the Title of Breakthrough Device from the U.S. FDA.

The device adopts an interbody fusion device, applied at L2 — S1.One or two adjacent levels ofTransforaminal Lumbar Interbody Fusion (TLIF) SurgeryMethod using Infuse™ Bone Graft for treatmentLumbosacral Degenerative Disease。

FDA Breakthrough Certification Will Accelerate the Development, Evaluation, and Review of New Technologies.

# Clinical Trial Patient Recruitment

Transforaminal Lumbar Interbody Fusion (TLIF):Through a posterior approach, unilateral facet joint resection is performed to expose the nerve root and dural structures within the spinal canal, thereby reducing the risk of nerve injury complications.

Infuse™ Bone Graft has been FDA approved forSpecific spinal, oral and maxillofacial, and orthopedic trauma surgeries。

Figure: Infuse Bone Graft with LT-CAGE Lumbar Tapered Fusion Device

Medtronic is currently recruiting patients for a prospective randomized clinical trial using Infuse™ in the TLIF approach at one or two adjacent levels from L2 to S1.

This trial aims to provide clinical evidence demonstrating the safety and effectiveness sufficient to expand the TLIF indications. ThereforeThe use of Infuse™ Bone Graft in TLIF surgery is currently in the research stage.

Michael Carter, Vice President and General Manager of Medtronic Spine and Biologics, stated:

"We thank the FDA for recognizing that Infuse has the potential to raise the standard of care for TLIF. Our goal is to expand the availability of this established technology to benefit more patients affected by debilitating spinal conditions."

# MedtronicBone Repair Product—Infuse Bone Graft

Medtronic's bone repair product, Infuse Bone Graft, has been approved by the NMPA for market release. The indication is for spinal fusion surgery in skeletally mature patients with degenerative disc disease at a single level from L2 to S1.

The product isDrug-device combination products, Product byRecombinant Human Bone Morphogenetic Protein InjectorAndSterile injectable rhBMP-2 Absorbable Collagen Sponge (ACS), syringe, and sterile water for injectionComposition.

Besides,Medtronic's orthopedic products also includeSpine and Orthopedic Surgery Related Products, providing products for the treatment of a series of cranial and spinal disorders, including spine conditions caused by trauma, spinal deformities, spinal tumors, and joint diseases.

# Main Products of Medtronic Spinal Surgery

Medtronic has a wide range of primary spinal treatment products, the main ones are as follows:

Kyphon™ Balloon Kyphoplasty Platform

Using orthopedic balloons to restore vertebral body height and correct angular deformities caused by osteoporosis, cancer, or benign lesions, and vertebral compression fractures.

After decompression, the balloon is deflated and removed, allowing for the controlled deposition of Kyphon bone cement to form an internal cast and stabilize the fracture.

Kyphon V™ Premium Vertebroplasty Platform

Designed to treat vertebral compression fractures, it maximizes the precision of high-viscosity bone cement placement while minimizing radiation exposure.

Vertex^®Reconstruction System

Composed of steel plates, rods, hooks, screws, polyaxial screws, and connecting components in various shapes and sizes, which can be locked onto the rods, each construct is custom-made for the patient.

Prestige LP Cervical Disc System

The first single-level and dual-level cervical disc approved by the FDA with 10 years of IDE study data. The design of this two-piece articulating metal-on-metal device allows for movement after implantation. It is made from a proprietary titanium-ceramic composite, free of nickel, cobalt, or chromium.

# Medtronic Mazor X™ Spine Surgery Robot

Compared with traditional spinal surgery, MAZOR™ X can provide preoperative planning and matching, intraoperative execution visualization, intelligent control, easy operation, and precise navigation for surgeons.

As the world's first spinal surgery robot to achieve full-process visualized operation, the MAZOR™ X Spine Surgery Intelligent Navigation Robot is able to realizeIntraoperative Navigation Fully Visible。

MAZOR™ XThe robotic arm passes through3D Spatial Scanning TechnologyScan and reconstruct the surgical area to achieveFully automatic and efficient positioning,Break through the limitations of traditional intraoperative field of view, operating blind spots and other problems, and improve the safety and precision of surgery.

Recently, Medtronic announced the full-dimensional upgrade of itsMazor X™️ Robotic Guidance System for Spine SurgeryAn integrated platform has been successfully launched in China, showcasing its cutting-edge digital and intelligent integration platform, a variety of advanced smart devices, and implants.AiBLE Intelligent Orthopedics Integrated Solution.

About Medtronic

Medtronic is a global leading medical technology company, founded in 1949, with its headquarters located in Minnesota, USA. The main product lines of Medtronic areThe four major businesses—cardiovascular, surgery and critical care, neuroscience, and diabetes—cover arrhythmia, heart failure, and cardiac intervention.Heart Valve Replacement, diabetes, gastrointestinal diseases, urinary system diseases, spinal diseases, nervous system diseases, and otorhinolaryngology treatment areas.

As a technology company, Medtronic is also committed to researching and developing new medical technologies to improve patients' quality of life. The company has numerous R&D centers and production bases worldwide, with a total workforce of over 90,000 employees. Medtronic's business spans more than 150 countries and regions globally.

On May 23, 2024, Medtronic released its latest financial report.Total revenue in 2023 was $31.227 billion (approximately 224.8 billion RMB), with a net profit margin of 12%, ranking second in sales volume in the global medical device market.

Orthopedic Communication Community

Sign Up! Orthopedic Medical Device Community, Recruiting

Innovative Orthopedic Medical Devices

China Orthopedic Innovative Device List [2023 Review]

International Orthopedic Enterprises

Stryker｜Johnson & Johnson|Zimmer Biomet ｜Medtronic | Smith+Nephew｜Enovis ｜NuVasive | Globus Medical｜Orthofix｜CONMED

Chinese Orthopedic Enterprises

Chunli Medical｜Sanyou Medical ｜WEGO Orthopaedics ｜Dabo Medical | Kailite Medical｜Aurora Medical ｜Haohai Bio-Tech ｜Aikon Medical