Medtronic has expanded its partnership with Merit Medical Systems to provide an unipedicular, steerable balloon catheter for the treatment of vertebral compression fractures (VCF) in the US.
Currently, Merit is supplying Medtronic’s Kyphon Xpander Inflation Syringes used to reduce fractures and create a void in the vertebral body during balloon kyphoplasty procedures.
Under the expanded partnership, Medtronic will carry out the sales, marketing, and distribution of the Kyphon KyphoFlex unipedicular balloon catheter.
Kyphon KyphoFlex is designed to create a controlled, precise, targeted cavity in vertebral augmentation procedures, and complement Medtronic’s current bipedicular solution.
Unlike non-adjustable curved catheters in the market, the Kyphon Kyphoflex is a steerable, curved catheter that enables modified trajectory once inside the vertebra.
Merit will be responsible for the manufacturing, quality and safety controls, regulatory activities, and life-cycle management for the Kyphon KyphoFlex balloon catheter.
Medtronic pain interventions vice president and general manager David Carr said: “We are thrilled to be teaming up with Merit Medical Systems as we look to bring additional choice and flexibility to our interventional therapies portfolio.”
Merit Medical Systems president Joe Wright said: “While we continue to deliver the ARCADIA Steerable portfolio to our physician customers and their patients, this latest effort will help deliver innovative steerable therapies to improve the lives of even more patients.”
Merit Medical OEM executive vice president Mike Blackham said: “Merit has always sought longstanding relationships with our customers, and our partnership with Medtronic goes back many years.”
VCFs are the most common osteoporotic fractures and balloon kyphoplasty uses orthopaedic balloons to restore some vertebral height and correct angular deformity from VCF.
The procedure involves a small balloon that is guided through a cannula into the vertebral body, which is then carefully inflated to raise the collapsed vertebra.
Once the balloon is deflated and removed, the cavity created by the balloon will be used for a controlled deposition of bone cement, which enables an internal cast and stabilises the fracture.
