Medtronic Partners with Merit Medical Systems to Launch Kyphon KyphoFlex Steerable Balloon Catheter for Vertebral Compression Fractures

Jun 24, 2024 08:02 CST Updated 08:02

Merit Medical

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Medtronic

Chronic Disease Medical Device and Therapy Developer

Source: Siyu MedTech

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Global medical technology leader Medtronic plc (Medtronic, plc.) recently announced a partnership with Merit Medical Systems, Inc. (NASDAQ: MMSI) to provide a unilateral steerable balloon catheter in the United States for the treatment of vertebral compression fractures (VCF).

As part of the agreement, Medtronic will be responsible for all sales, marketing, and distribution of the Kyphon KyphoFlex unilateral balloon catheter.Merit Medical SystemsWill be responsible for other manufacturing aspects of the catheter, including quality and safety control, regulatory activities, and lifecycle management.

This latest agreement expands the ongoing partnership between the two companies, in which,Merit Medical SystemsSupply MedtronicKyphon XpanderInflation Syringes, these syringes are used for balloon kyphoplasty.

# New Treatment Options for Vertebral Compression Fractures

Vertebral compression fractures are the most common type of osteoporotic fracture, affecting 14 million people worldwide. According to the National Osteoporosis Foundation, approximately 54 million Americans have osteoporosis or low bone mass, putting them at higher risk for fractures. Fractures are a serious complication of osteoporosis, especially for elderly patients.

Balloon kyphoplasty uses orthopedic balloons to restore partial vertebral height and correct angular deformities of VCFs caused by osteoporosis, cancer, or benign lesions.

A small balloon is guided into the vertebral body through a catheter. The balloon is then carefully inflated to lift the collapsed vertebra. After the balloon is deflated and removed, the resulting cavity allows for controlled placement of bone cement — which helps form an internal cast and stabilize the fracture.

In this field, Medtronic has established its leadership in the spinal treatment market with its outstanding innovation capabilities and extensive product line. In 2007, Medtronic made a significant acquisition of Kyphon for $3.9 billion. This strategic move not only enriched its spinal product portfolio but also solidified its leading position in the global spinal health sector, earning it the title of "the king of the spinal field."

However, with nearly two decades of technological evolution and market competition, Medtronic has also realized that in certain niche markets, its products require further innovation and improvement to maintain a competitive edge.Especially in the细分领域 of balloon kyphoplasty, Medtronic's Kyphon Balloon Kyphoplasty technology, as a pioneer in the market, belongs to the "bilateral approach" school within this technical field and demonstrates more significant treatment outcomes compared to the "unilateral approach," owing to its advantages in clinical research.

The latest clinical research results show that there are statistically significant differences in all evaluated metrics between unilateral and bilateral balloon kyphoplasty. Specifically, the lift generated by the bilateral approach is 105% higher than that of the unilateral approach, with values of 102.66 pounds and 49.99 pounds, respectively. In terms of contact area, the bilateral method covers 279% more area than the unilateral method, with measurements of 1.34 square inches and 0.48 square inches, respectively. Additionally, the stress applied by the bilateral approach is 26% lower than that of the unilateral approach, with values of 77.97 psi and 105.00 psi, respectively.

Although the Kyphon Balloon Kyphoplasty technique has shown positive outcomes in studies, it does not fully overcome the challenges associated with balloon expansion within the vertebral body and cement distribution.In bilateral puncture techniques, it is relatively easy to achieve uniform distribution of bone cement within the vertebral body, but achieving ideal fusion of the bone cement from both sides in the central region of the vertebral body remains challenging.

For unilateral puncture techniques, although the diffusion of bone cement towards the midline region can be achieved by precisely controlling the puncture angle and pedicle direction, the diffusion effect in the midline region is generally weaker compared to bilateral methods.

Therefore, in order to address this clinical challenge, innovators in the industry are developing new technologies. Among them, flexible vertebral augmentation devices and balloon techniques have become new directions for exploring solutions, aiming to improve the uniform distribution of bone cement within the vertebral body and optimize treatment outcomes.

Kyphon KyphoFlex aims to achieve controlled, precise, and targeted cavity creation in vertebral augmentation procedures. The unilateral solution will complement Medtronic's current bilateral balloon kyphoplasty offerings, providing clinicians with additional flexibility and options.

Unlike the non-adjustable curved catheters provided by competing products on the market, Kyphon Kyphoflex is aSteerable Curved Catheter, once entering the vertebral bone, allows for trajectory adjustment to achieve optimal positioning.

# Executive Evaluation

"We are delighted toMerit Medical Systems"Collaboration, because we want to bring additional options and flexibility to our interventional treatment portfolio," said David Carr, Vice President and General Manager of the Pain Interventions division within Medtronic's Neuromodulation business, which is part of Medtronic's Neuroscience portfolio.

"We thank Medtronic forMerit Medical"Confidence in technology. While we continue to provide our physician customers and their patients with the ARCADIA™ steerable portfolio, this latest effort will help deliver innovative steerable therapies to improve the lives of more patients."Merit Medical SystemsPresident Joe Wright said.

“Merit Medical Systems"Committed to building long-term relationships with our customers, our partnership with Medtronic has spanned many years."Merit Medical Systems "OEM Executive Vice President Mike Blackham said, 'We are delighted to leverage our operational expertise to deliver exceptional technology on their behalf.'"

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Editor-in-Chief | Zhao Qing Reviewed by | Yi He