Tyber Medical Launches Clinical Study for Titanium Integrated Interbody Devices

Tyber Medical Launches Clinical Study for Titanium Integrated Interbody Devices

PR Newswire

BETHLEHEM, Pennsylvania, Oct. 6, 2020

Leader in vertically-integrated orthopedic medical devices makes significant investment in clinical research to support outcome data and leading MDR strategy

BETHLEHEM, Pennsylvania, Oct. 6, 2020 /PRNewswire/ --Tyber Medical, LLC, a leading manufacturer of private label orthopedic and spinal implants, providing rapid access to FDA-cleared and CE-marked devices in the spine, extremity and trauma markets, has launched a clinical study focusing on its titanium-integrated interbody fusion devices for use in the cervical and lumbar spine. The study aims to provide neuro- and orthopedic spine surgeons in the United States and Europe with clinical data that supports the safety and effectiveness of these devices when used for spinal indications including degenerative disc disease, stenosis, fractural repair and other degenerative and trauma-related conditions.

AP radiograph of Tyber Medical’s titanium-integrated Polyetheretherketone (PEEK) interbody fusion device at A. 2 months and B. 5 months showing early integration with the vertebral endplates.  C. Coronal CT scan at 10 months showing bone bridging across the interbody space.  Images courtesy of Dr. Matthew Gary of the Emory Spine Center.

 

The study aims to provide clinical data on the safety and effectiveness of Tyber's titanium-integrated PEEK devices.

The devices included in Tyber Medical's clinical registry are titanium-integrated Polyetheretherketone (PEEK) devices that offer titanium integration for solid bone formation between the interbody device and surrounding tissues following spinal fusion surgery, maximizing the potential for bone growth.

According to spinal surgeon Dr. Gordon Donald, the study's medical director, early osteo-integration of the interbody fusion devices and segment stability are being seen during patient recovery.  "Titanium- integrated interbody implants, by virtue of their thin contact surfaces, can be seen to show early and, most often, complete bony integration with vertebral endplates. This assures early biologic structural integrity of the fusion segment, allowing for rapid patient mobilization and decreasing implant subsidence. The early structural support being reported in patients will likely lead to earlier bridging bone across the interspace completing the fusion healing process."

Tyber Medical fills gaps in existing distribution networks by providing cutting-edge, design, engineering, quality management and regulatory support and delivers those solutions through its vertically-integrated, manufacturing operation. "The significant investment we're making in prospective and retrospective data collection and our leading MDR strategy provides customers with outcome data that supports the safety and effectiveness of our devices for domestic and international use," said Tyber Medical Director of Clinical Research, Hallie Murray, PhD. 

Participating in the clinical study are several well-known physicians and research institutions including: The Ohio State University Wexner Medical Center, Emory University Hospital, Jefferson Health-Thomas Jefferson University Hospitals, OrthoCarolina Research Institute, and MultiCare Institute of Research and Innovation.     

About Tyber Medical, LLC
Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to private label, portfolio-enhancing, regulatory-approved, orthopedic implants for the spine and extremity/trauma markets. Tyber Medical provides customers with a quick and seamless path to market. Since it was founded in 2012, the company has released 18 spine and 33 extremity/trauma systems. Tyber Medical aims to develop and utilize differentiated, bioengineered technologies including different surface treatments and coatings to make advanced orthopedic implants. 

Contact: Eric Dickson, Tyber Medical
Phone: 610-849-1710
Email: edickson@tybermed.com

(PRNewsfoto/Tyber Medical, LLC)

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