Medtronic Announces Strategic Collaboration with Merit Medical to Launch Kyphon KyphoFlex for Vertebral Compression Fracture Treatment

Jun 24, 2024 19:37 CST Updated 19:37

Medtronic

Medical Device Manufacturer

Source | Device Home

Recently, Medtronic announced a partnership with Merit Medical (hereinafter referred to as "Merit").Introducing a single steerable balloon catheter for the treatment of minimally invasive vertebral compression fractures (VCF) – Kyphon KyphoFlex.

Rui Mai Tong is a global leading manufacturer of proprietary disposable devices for cardiac and radiological interventional procedures. The company developsKyphon KyphoFlex is a steerable, curved catheter used to treat pathological vertebral fractures caused by osteoporosis, cancer, or benign lesions.

According to the agreement between both parties,Medtronic will be fully responsible for the sales, marketing, and distribution of the product, while Ruimaitong will handle the manufacturing of the catheter, including quality and safety control, regulatory affairs, and lifecycle management.This collaboration further deepens the existing partnership between the two companies. Previously, Raymed has supplied Medtronic with the Kyphon Xpander Inflation Syringe for use in balloon kyphoplasty.

David Carr, Vice President and General Manager of Pain Interventions at Medtronic's Neuroscience division, stated: "We are very pleased to collaborate with Merit Medical Systems to bring more choices and flexibility to our interventional therapies portfolio."

Strengthen Cooperation, Supplement Production Line

Balloon Kyphoplasty (BKP) is a percutaneous treatment method for tumor-related vertebral compression fractures.Aimed at restoring vertebral height using orthopedic balloons and correcting vertebral compression fractures caused by osteoporosis, cancer, or benign lesions.

This procedure introduces a small balloon into the vertebral body through a cannula and inflates it to elevate the collapsed vertebra. Subsequently, the balloon is deflated and removed, and the resulting cavity can be controllably filled with bone cement to help form an internal brace and stabilize the fracture.

The Kyphon KyphoFlex catheter from Raymed can create precise and controlled target cavities during vertebral augmentation procedures. The catheter's curved design allows for more flexible trajectory adjustments within the vertebra, enabling better target positioning and complementing Medtronic's existing bilateral balloon kyphoplasty products.

Kyphon Balloon Kyphoplasty System

Kyphon Balloon Kyphoplasty System isMedtronic's existing bilateral balloon kyphoplasty product.

The product consists of four components in total:Bone access tools, balloons and inflation devices for fracture reduction, bone cement and cement delivery systems, and other accessories.

Among them,Kyphon VuE™ Bone Cement is a fast-setting, high-viscosity, radiopaque PMMA cement containing enhanced barium particles.These particles can enhance the fluoroscopic visibility of cement flow during vertebral augmentation procedures.

According to Medtronic, measurements of balloon lift force, balloon contact area, and pressure applied by the balloon in previous engineering test environments showed,Compared with unilateral balloon kyphoplasty, bilateral balloon kyphoplasty exerts less stress on the endplate of the in vitro model but provides greater lifting force.

The results showed that there were significant statistical differences between unilateral and bilateral balloon kyphoplasty in all evaluated characteristics. The lifting force of bilateral balloon kyphoplasty was 105% higher than that of the unilateral method (102.66 lbf vs. 49.99 lbf, respectively). The contact area of the bilateral method was 279% that of the unilateral method (1.34 square inches vs. 0.48 square inches, respectively).

Moreover, the stress applied by bilateral balloon kyphoplasty is 26% less than that of the unilateral method (77.97 psi vs. 105.00 psi).

In summary,The Kyphon Balloon Kyphoplasty System has three major features and advantages:

The maximum inflation pressure is 700 psi.Higher than the previous 400 psi balloon;
Cement resistance technology allows for the delivery of cement through a cannula while maintaining the inflation of the lateral balloon to preserve fracture reduction;
Kyphon Cement Delivery System (CDS) allows for use during kyphoplasty procedures,Deliver cement from a position 48 inches away from the radiation source.

The King of Spine——Medtronic

This collaboration not only marks an important step for Medtronic and Ruimaitong in the medical device field but also represents another milestone in orthopedics and neurosurgery.

In fact, orthopedics does not account for a large portion of Medtronic's business, but itsA global leader in spinal products.Medtronic's layout in spinal and neurosurgery can be traced back to 1998, when Medtronic acquired the neurosurgery company MidusRexlP to enter the market. In the same year, it also acquired Sofamor Danek, further enriching its range of equipment and products related to neurosurgery.

Between 2002 and 2007, Medtronic continued to consolidate its market position by acquiring a series of spine surgery-related companies and products.In 2010, Medtronic's spinal business revenue reached $3.5 billion, making it the world's largest spinal product manufacturer.In 2012, Medtronic acquired Kanghui Medical and took a dominant position in the Chinese spinal market, further strengthening its leading position in the global spinal market.

December 29, 2018Medtronic Announces $1.7 Billion Acquisition of Mazor Robotics and Its Robotic-Assisted Surgery PlatformAnd launched the Mazor X Stealth™ robotic-assisted spine surgery platform. According to reports,The China-produced fully upgraded Mazor X™️ Eagle Spine Surgical Robotic Integrated Platform has been successfully launched in China in May.

Medtronic's continuous investment and innovation in the fields of spine and neurosurgery keep it at the forefront of the market. Its products and technologies in these areas are extensive.From spinal fusion devices, minimally invasive spinal surgery equipment to neuromodulation devices and neuro-navigation systems,Medtronic continuously launches innovative solutions to meet clinical needs and improve patients' quality of life.

Through years of accumulation and development, Medtronic has built a strong brand reputation and market network in the global market. Its products are sold in multiple countries and regions, with influence covering the world. The company's technological innovation and extensive product portfolio ensure its leading position in the spine and neurosurgery markets.

Medtronic's Layout in China

Focusing on the Chinese market,Medtronic China Orthopedics and Neurosurgery Business Group owns two major brands, Medtronic and Kanghui, with continuous technology introduction, strong local R&D, high-end manufacturing, innovative incubation, and professional education and services.Comprehensive local capabilities provide Chinese patients and doctors with diversified products and solutions, while empowering the local innovation value chain.

In June 2022, Medtronic Kanghui signed a strategic investment and cooperation agreement with the Changzhou National High-tech Industrial Development Zone to jointly buildMedtronic Kanghui Changzhou Science Park. Aiming to build a leading industrial hub for orthopedics and neurosurgery that radiates across the Yangtze River Delta region. This itemEye PositioningMedtronic Global Production Base and Kanghui Medical Global Headquarters, includingPerfect the Intelligent Manufacturing Center, the R&D Excellence Center, the Innovation Incubation Center, and the Innovation Experience Center.

In July last year, Medtronic Kanghui reached a strategic cooperation with Huashan Hospital Affiliated to Fudan University ("Huashan Hospital"). Both partiesWill integrate respective high-quality resources, be patient demand-oriented, share technical achievements, and share resource services., creating a "Neuroscience Industry-Medicine Integration Innovation Platform" with a dumbbell-shaped dual-center layout.Huashan Hospital is alsoThe first batch of "users" of the innovation incubator。

In this regard, Medtronic has achieved a complete local value chain covering R&D, production, sales, clinical training, incubation, and funds. This has been Medtronic's relentless pursuit during its more than 30 years in China. Currently, the company is planning to build a new innovation center in China. In the future, Medtronic China's neurosurgery product line will be further expanded and optimized, which is worth looking forward to.

In terms of the market, with the aggravation of China's population aging, the incidence of bone diseases is also constantly rising. Currently,The proportion of people aged 60 and above in China has reached 18.7%, with a population of approximately 260 million.

As people age, their bones gradually degenerate, making the elderly more susceptible to various skeletal diseases. Statistics show that among individuals aged 60 and above in China, the prevalence of vertebral fractures is approximately 18%, with osteoporotic vertebral compression fractures accounting for 11%.It is estimated that approximately 4.3 million patients in China are troubled by osteoporotic vertebral compression fractures.

Driven by the deepening of population aging and the popularization of minimally invasive surgery, the market size of vertebral body dilation balloon catheters in China has shown a rapid growth trend.By 2020, the market size had reached 1.9 billion yuan and is expected to increase to 3.3 billion yuan by 2023, demonstrating strong growth potential.

Currently, there are several companies in China engaged in the production of vertebral body dilation balloon catheters, including Elliteck, A&D Suzhou, Vertecon, and Medtronic.

With a market share of approximately 38%, Kellytech has become the leading company in this field in China.Aid and Vedcure in Suzhou also gradually expand their market share through continuous technological innovation and product optimization.

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