Medtronic plc, a global leader in healthcare technology, today announced that it has entered into a partnership with Merit Medical Systems, Inc. (NASDAQ: MMSI), to offer a unipedicular, steerable balloon catheter for treating vertebral compression fractures (VCF) in the United States. This agreement expands an ongoing partnership between Medtronic and Merit, with Merit currently supplying Medtronic’s Kyphon™ Xpander™ Inflation Syringes used in balloon kyphoplasty procedures.

Pursuant to the agreement, Medtronic will be responsible for all sales, marketing and distribution of the Kyphon™ KyphoFlex™ unipedicular balloon catheter. Merit will be responsible for the manufacturing, quality and safety controls, regulatory activities, and life-cycle management. 

Vertebral compression fractures are the most common osteoporotic fractures affecting 1.4 million people worldwide.¹ According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis or low bone mass that puts them at increased risk for a fracture. Breaking a bone is a serious complication of osteoporosis, especially with older patients.

Balloon kyphoplasty uses orthopedic balloons to restore some vertebral height and correct angular deformity from VCF due to osteoporosis, cancer, or benign lesions.² A small balloon is guided through a cannula into the vertebral body. The balloon is then carefully inflated to raise the collapsed vertebra. Once the balloon is deflated and removed, the resulting cavity allows for a controlled deposition of bone cement — which helps form an internal cast and stabilize the fracture.

The Kyphon KyphoFlex is designed to achieve controlled, precise, targeted cavity creation in vertebral augmentation procedures. The unipedicular solution will be complementary to Medtronic’s current bipedicular balloon kyphoplasty solution, giving clinicians added flexibility and choice.

Unlike non-adjustable curved catheters offered by the competition, the Kyphon Kyphoflex is a steerable, curved catheter allowing modified trajectory once inside the vertebra, for optimal targeting.³

“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,” said David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. 

“We appreciate the confidence that Medtronic has in Merit’s technology. 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,” said Joe Wright, President, Merit Medical Systems.

“Merit has always sought longstanding relationships with our customers, and our partnership with Medtronic goes back many years,” said Mike Blackham, Executive Vice President, OEM, Merit Medical. “We are pleased to use our operational expertise to deliver exceptional technology on their behalf.”

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.