Source: Bone Future; Editor: Wu Zexi
Reprint Requirements: You can directly republish, but please credit the source at the beginning of the article.On March 1, 2024, Medtronic announced that its OsteoCool 2.0 Bone Tumor Ablation System received clearance from the U.S. Food and Drug Administration (FDA) for the treatment of painful bone metastases and benign bone tumors, such as osteoid osteoma. The company plans to launch OsteoCool 2.0 with limited availability in the market immediately and expand its availability across the United States later this year.# Disease Background
According to literature reports, 60%-84% of malignantPatients with tumors may experience bone metastasis.Metastatic bone tumors refer to malignant tumors that originate in other parts of the body and spread to the bones through various pathways, continuing to grow within the bone to form secondary tumors.Bone metastasis tumors are often associated with breast cancer., Lung Cancer, Prostate CancerThe transfer bone is high.Bone metastases from tumors often severely reduce the patient's quality of life, causing symptoms such as pain, fractures, and decreased mobility. They may also lead to emotional changes, and even depression and anxiety.
The first-line treatment for patients with metastatic bone tumors is mainly palliative care, including local treatment, systemic treatment, and analgesic treatment. External beam radiation therapy is the standard treatment for localized bone pain and can relieve pain symptoms in the majority of patients. However, 20%-30% of patients may not achieve effective pain relief. Additionally, due to the limitations of normal tissue tolerance, patients experiencing recurrent pain at previously irradiated sites may not be suitable for further radiotherapy.
# Product Introduction
Medtronic is a global TOP enterprise in the field of orthopedic devices and one of the three giants in the neuromodulation market.Medtronic has successively acquired Covidien's tumor ablation systems, including the Covidien Emprint™ microwave ablation system and the Cool-tip™ radiofrequency ablation system, as well as EPIX Therapeutics, a cardiovascular radiofrequency ablation company, and CryoCath Technologies, a cryoablation company, gradually solidifying its position in the ablation field.In 2016Announces U.S. Food and Drug Administration (FDA) Approval of Its OsteoCool(TM) Radiofrequency Ablation System for Market Release in the United StatesRadiofrequency Ablation (RFA) therapy uses high-frequency alternating current delivered from a needle electrode to the surrounding tissue, causing frictional heating and leading to tissue necrosis. RFA has been extensively studied for the treatment of primary and metastatic diseases involving the liver. Currently, substantial clinical evidence has confirmed that RFA can effectively alleviate pain symptoms in patients with bone metastases.Minimally invasive surgery using the OsteoCool Radiofrequency Ablation System delivers radiofrequency energy through probes.Heat and destroy the tumor. Meanwhile, cool the probe near the active tip with circulating water to avoid excessive heating.During the surgical procedure, physical positioning technology is utilized through an adapted bone puncture system (puncture needle + high-precision drill).OsteoMAPSMClearly define the boundaries before and after ablation to make the ablation more precise.Thermocouple technology at the tip of the electrode needle provides real-time temperature information on the main screen, measures the boundaries of the ablation zone, and helps prevent thermal damage to adjacent critical structures. When the distal target temperature is 70°C, the electrode will ablate within the preset time and generate a predictable ablation zone.Through upgraded design, the OsteoCool 2.0 Radiofrequency Ablation System offers many new advantages compared to the previous generation. Medtronic's system can be used simultaneously.Four Internal Cooling Probes. Doctors can use itSimultaneous Ablation of Two Vertebrae, or create a larger ablation zone in non-spinal applications.OsteoCoolIs on the marketThe Most Powerful Bone Tumor Ablation System, each channel can provide 20 watts of power. Medtronic claims that this power far exceeds Stryker's OptaBlate Bone Tumor Ablation System (7.5 watts per channel), and it also offers four probe sizes to choose from, which is unique in the U.S. market.Medtronic states that OsteoCool remains the only bone tumor ablation platform on the market using internal cooling probes. It delivers predictable ablation, reduces the risk of heating around the lesion site, and effectively alleviates pain.This clinically validated technology is supported by OPUS One, the largest research project on radiofrequency ablation for bone metastases.OPuS OneThe first 206 patients treated with the OsteoCool™ Radiofrequency Ablation System for bone metastases, followed by cementoplasty at the operator's discretion, and followed up for 12 months. The results showed that the most severe pain improved within 3 days after surgery, with improvements in the most severe and average pain as well as pain interference at all follow-ups, and long-term pain relief lasting for 12 months."David Carr, Vice President and General Manager of Medtronic's Neuromodulation Business Pain Interventions, said: 'OsteoCool 2.0 is a welcome upgrade to our interventional portfolio, further solidifying our position as the most innovative and comprehensive pain management portfolio in the industry.'""Patients with spinal metastatic disease often experience severe pain and a significant decrease in quality of life," said Dr. Jonathan Morris, a neuroradiologist. "OsteoCool 2.0, building on years of experience from the previous version, can better help me alleviate patients' pain and restore their normal activities."Medtronic is a global leading medical technology company, founded in 1949, with its headquarters located in Minneapolis, Minnesota, USA. The company is mainly committed to providing lifelong treatment, diagnosis, and monitoring solutions for patients with chronic diseases such as cardiovascular disease, neurology, diabetes, and spinal disorders.On February 20, 2024, Medtronic (NYSE: MDT) released its third-quarter financial report for the fiscal year 2024, which ended on January 26. The report showed that the company's quarterly revenue was $8.1 billion (approximately 58.2 billion RMB), a year-over-year increase of 4.7%; the quarterly net profit was $1.34 billion, an increase of 8.8% year-over-year. (Click the image to jump to Medtronic's latest financial report)Orthopedic Communication Community
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