Medtronic and Merit Medical Announce Strategic Collaboration to Launch Kyphon KyphoFlex for Vertebral Compression Fracture Treatment
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Recently, Medtronic announced a partnership with Merit Medical (hereinafter referred to as "Merit Medical"),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 options and flexibility to our interventional therapies portfolio."
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 by Ruimaitong can create precise and controlled target cavities during vertebral augmentation procedures. The catheter's curved design allows for more flexible trajectory adjustments within the vertebral body, enabling more optimal targeting and complementing Medtronic's existing bilateral balloon kyphoplasty products.
Kyphon Balloon Kyphoplasty System
Kyphon Balloon Kyphoplasty System isMedtronic's existing bilateral balloon kyphoplasty products.
The product is packaged in a total ofContaining four components: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.
Kyphon Xpede™ Cement and Mixer (CX01B)
According to Medtronic, in the previous engineering test environment, measurements were taken for balloon lift force, balloon contact area, and pressure applied by the balloon.Indicates,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 respectively).Pounds per square inch to 105.00 pounds per square inch).
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 keeping the side balloon inflated to maintain 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.
This collaboration not only marks MedtronicThis is an important step for Medtronic and Reimeitong in the medical device field, and another milestone in orthopedics and neurosurgery.
In fact, orthopedicsMedtronic's business accounts for a small proportion, 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 Healthcare and entered the spinal market in China.This move further strengthens its leading position in the global spinal market.
December 29, 2018Medtronic Announces $1.7 Billion Acquisition of Mazor Robotics and Its Robot-Assisted Surgery PlatformAnd launched the Mazor X Stealth™ robotic-assisted spine surgery platform. According to reports,The China-produced fully upgraded Mazor X™️ Hawk spinal surgical robotic integrated platform has been successfully launched in China in May.
Mazor X Stealth Edition Robotic Guidance System
Medtronic's continuous investment and innovation in the fields of spinal and neurosurgery have kept 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 neuronavigation systems,Medtronic continuously launches innovative solutions to meet clinical needs and improve patients' quality of life.
Through years of accumulation and development, Medtronic has established a strong brand reputation and market network in the global market. Its products are sold in many 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.
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 localAbility to provide diversified products and solutions for patients and doctors in China, while empowering the local innovative 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 and Technology Park. Aiming to build a highland for the orthopedic and neurosurgical industries that radiates across the Yangtze River Delta. This itemEye PositioningMedtronic Global Production Base and Kanghui Medical Global Headquarters, includingImprove the Intelligent Manufacturing Center, R&D Excellence Center, Innovation Incubation Center, and Innovation Experience Center.
In July last year, Medtronic Kanghui reached a strategic cooperation with Huashan Hospital Affiliated to Fudan University (referred to as "Huashan Hospital"). Both partiesWill integrate respective high-quality resources, be patient-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's neurosurgery product line in China will be further expanded and optimized, which is worth looking forward to.
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In terms of the market, with the aggravation of China's population aging, the incidence of bone diseases is also 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 deteriorate, making the elderly more susceptible to various skeletal diseases.According to statistics, the prevalence of vertebral fractures among people aged 60 and above in China is approximately 18%, of which patients with osteoporotic vertebral compression fractures account 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, showing strong growth potential.
Currently, there are several companies in China engaged in the production of vertebral body dilation balloon catheters, including Kailite, A&D Suzhou, Weidekang, and Medtronic.
Kailite becomes the leading company in this field in China with a market share of about 38%.Suzhou Aide and Weidkang have also gradually expanded their market share through continuous technological innovation and product optimization.
Medtronic, as a globally renowned medical device company, has a significant presence in the Chinese market. Its collaboration with Kanghui Healthcare has strengthened its competitiveness in the spinal surgery field. This partnership with Ruimaitong will bring more benefits to patients in China and even globally. Medical Device News will continue to follow these developments.
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