Boston Scientific to Present Key Data at the 2024 American Society of Pain & Neuroscience Conference
Boston Scientific to Present Key Data at the 2024 American Society of Pain & Neuroscience Conference
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MARLBOROUGH, Mass., July 8, 2024 -- Boston Scientific Corporation (NYSE: BSX) today announced the company's clinical data will be featured at the sixth annual American Society of Pain & Neuroscience (ASPN) conference, which will be held in Miami Beach, Florida, on July 11-14, 2024. A total of 15 abstracts and posters will be presented, including a study of five-year pooled data for the Intracept Procedure System that measures outcomes across three clinical trials. The Intracept procedure system includes the only U.S. Food and Drug Administration cleared devices for the treatment of vertebrogenic low back pain, a distinct type of pain caused by damage to vertebral endplates, which interface between the disc and the vertebral body. The pooled data are based on a five-year follow-up study of 249 patients with vertebrogenic pain and treated with the Intracept procedure system. Patient-reported Oswestry Disability Index (ODI) and numeric pain scores were compared to baseline. Secondary outcomes measured included numeric pain score quartiles, responder rates, patient satisfaction and healthcare utilization. Of the 30 million people in the U.S. with chronic low back pain, one in six are likely to have vertebrogenic pain[1] Patients typically have pain in the middle of their low back, which worsens when they bend over, sit for long periods of time, or when they are active. A physician can confirm a patient's pain is vertebrogenic by observing modic changes, a biomarker seen on standard MRI that indicates inflammation at the vertebral endplate. "Boston Scientific provides innovative solutions that help patients with chronic pain and neurological conditions get back to their daily lives," said Ray Baker, M.D., vice president and chief medical officer, Neuromodulation, Boston Scientific. "The data shared at the 2024 ASPN Annual Meeting demonstrate the clinical effectiveness of our entire interventional pain portfolio, including meaningful clinical evidence on lasting relief from vertebrogenic pain." Additional data to be presented by Boston Scientific include clinical outcomes on FAST Therapy (Fast-Acting Sub-Perception Therapy) with spinal cord stimulation (SCS) as well as one-year results from the SOLIS (SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery) randomized control trial. Featured Presentations Poster presentations:
Oral presentations:
For a complete list of Boston Scientific clinical and scientific data presentations at the 2024 ASPN conference, please visit: . About the Boston Scientific Chronic Pain Portfolio The Boston Scientific portfolio of advanced chronic pain management solutions is designed to deliver lasting relief to improve the quality of life for the millions of people living with pain worldwide. Supported by robust clinical evidence, the comprehensive suite of transformative therapies includes the WaveWriter Alpha Spinal Cord Stimulator System, Intracept Procedure, Radiofrequency Ablation, and the Vertiflex Procedure† to provide safe and effective therapy options that help physicians address the unique needs of their patients. About Boston Scientific Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, product performance and impact, new and anticipated product approvals and launches and clinical trials. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; the execution and effect of our business strategy, including cost savings and growth initiatives; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this press release. CONTACTS: Media: Lisa Ferrer Investor Relations: Jon Monson |
Intracept Procedure System = Intracept Intraosseous Nerve Ablation System |
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2024年7月8日，馬爾博勒，波士頓科學公司（紐交所：BSX）宣佈公司的臨床數據將在第六屆美國疼痛和神經科學學會年會（ASPN）上亮相，該年會將於2024年7月11-14日在佛羅里達州邁阿密海灘舉行。將展示總共15篇文章和海報，包括一項針對Intracept程序系統的五年彙總數據研究，該系統衡量了三項臨床試驗中的結果。 Intracept程序系統包括唯一獲得美國食品和藥物管理局認可的設備，用於治療脊椎源性下背痛，這是一種由於椎體板損傷引起的不同類型疼痛，介於椎間盤和椎體之間。 彙總數據基於對249名患有脊椎源性疼痛並接受Intracept程序系統治療的患者進行的爲期五年的隨訪研究。將患者報告的Oswestry殘疾指數（ODI）和數字疼痛評分與基線進行比較。其他測量的次要結果包括數字疼痛評分四分位數、反應者比例、患者滿意度和衛生保健利用率。 在美國有3000萬人患有慢性下背痛，其中六分之一可能患有脊椎源性疼痛[1]，患者通常在低背部中感到疼痛，在彎腰、長時間坐着或運動時疼痛加劇。醫生可以通過觀察標準磁共振成像上看到的modic變化，即在椎體板處出現的生物標誌物來確認患者的疼痛是脊椎源性的。 "波士頓科學提供創新解決方案，幫助患有慢性疼痛和神經疾病的患者回到日常生活中，"波士頓科學神經調製劑副總裁兼首席醫療官Ray Baker 萬博士說，"2024年ASPN年會上分享的數據證明了我們整個介入性疼痛組合的臨床有效性，包括有關脊椎源性疼痛持久緩解的有意義的臨床證據。" 波士頓科學將展示的其他數據還包括使用脊髓刺激（SCS）的FASt治療（快速亞感知治療）的臨床結果以及SOLIS（作爲慢性下背痛和/或腿痛的替代手術的SCS選項）隨機對照試驗的一年結果。 特色演講 海報展示:
口頭展示:
有關波士頓科學臨床和科學數據在2024年ASPN年會上的完整列表，請訪問: 有關波士頓科學慢性疼痛組合的介紹 波士頓科學的先進慢性疼痛管理解決方案組合旨在提供持久緩解，改善全球數百萬患病人士的生活質量。支持強大的臨床證據，全面的變革療法套件包括WaveWriter Alpha脊髓刺激系統、Intracept程序、射頻消融和Vertiflex程序†，提供安全有效的治療選擇，幫助醫生應對患者的獨特需求。 關於波士頓科學 關於前瞻性聲明的警示性聲明 本發佈將包含適用證券法的前瞻性信息（"前瞻性聲明"），涉及Descartes的運輸管理解決方案和潛在的由此獲得的好處；和其他事項。這樣的前瞻性聲明涉及已知和未知的風險、不確定性、假設和其他因素，可能導致實際結果、表現或成就不同於預期的結果、表現或成就或發生的發展所表達或暗示的發展。諸如代表性的因素和假設在提交給證券交易委員會、安大略證券委員會和加拿大全國證券委員會的文件中討論，包括Descartes最近提交的管理層討論和分析文檔中。如果任何此類風險確實發生，他們可能會對我們的業務、財務狀況或運營結果造成實質性的負面影響。如果出現這種情況，我們普通股的交易價格可能會下跌，甚至可能趨於實質。讀者被警告不要對任何此類前瞻性聲明抱有過高的依賴性，這些聲明僅在發表之日有效。前瞻性聲明是爲了提供關於管理層當前的期望和計劃，涉及未來的目的。讀者被警告，這樣的信息可能不適用於其他目的。我們不承擔任何更新或修訂任何前瞻性聲明的任何義務或承諾，以反映任何基於法律要求的期望或任何該聲明所基於的事實、情況或環境的任何變化，除非法律規定。 本新聞稿包含根據1933年證券法第27A條和1934年證券交易法第21E條作出的前瞻性聲明。可通過像"預計"，"期望"，"計劃"，"相信"，"規劃"，"估計"，"打算"等詞語來確定前瞻性聲明。這些前瞻性聲明是基於我們在當時可獲得的信息使用的信仰、假設和估計，並不旨在成爲未來事件或業績的保證。這些前瞻性聲明包括，但不限於，關於我們的商業計劃、產品性能和影響、新產品批准和推出以及臨床試驗的聲明。如果我們的基本假設被證明是不正確的，或者如果某些風險或不確定性實現了，實際結果可能會與我們的前瞻性聲明所表達或暗示的期望和投影有所不同。這些因素，在某些情況下，已經影響過，未來（連同其他因素）可能影響我們實施業務策略的能力， 並可能導致實際結果與本新聞稿中表述的陳述不符。因此，讀者被警告不要對我們的任何前瞻性聲明放置過度的依賴。 可能會引起這種差異的因素包括但不限於：未來的經濟、政治、競爭、報銷和監管條件，新產品推出，人口統計趨勢，知識產權，訴訟，金融市場條件，我們的業務戰略的執行和影響，包括成本節約和增長舉措；我們和我們的競爭對手未來的業務決策。所有這些因素都難以或者不可能準確預測，其中許多因素超出了我們的控制範圍。有關這些和其他重要風險和不確定性的完整列表和描述，可能會影響我們未來運營的，請參閱我們最新的10-k年度報告文件的第I部分、第1A條-風險因素，在此之後的季度10-Q報告文件的第II部分，第1A條-風險因素，我們可能會進行更新。 我們否認公開更新或修訂任何前瞻性聲明，以反映我們的期望或事件、條件或環境的變化，或可能影響實際結果與前瞻性聲明中包含的結果不同的可能性，除非法律另有規定。本警告聲明適用於本新聞稿中包含的所有前瞻性聲明。 聯繫方式： 媒體： Lisa Ferrer 投資者關係: Jon Monson |
Intracept程序系統 = Intracept骨內神經消融系統 |
[1] Hoy D, March L, Brooks P, et al. The global burden of low back pain; estimates from the Global Burden of Disease 2010 study. Annals of the Rheumatic Diseases 2014;73:968-974. global point prevalence of LBP was 9.4% (95% CI 9.0 to 9.8), (333M U.S. pop * 9.4% = 31M); Lorio et al. International Journal of Spine Surgery December 2022, 16 (6) 1084-1094; DOI: estimated that 15% of CLBP patients suffer from primary vertebrogenic pain.
[1] Hoy D，March L，Brooks P等。低背痛的全球負擔：來自2010年全球疾病負擔研究的估計。《風溼病學雜誌》2014年；73：968-974。全球患有LBP的點預valence爲9.4％（95％CI 9.0至9.8），（33300萬美國人口* 9.4％= 3100萬）; Lorio等人。2022年12月國際脊柱外科雜誌，16（6）1084-1094; DOI：估計15％的CLBP患者患有原發性脊椎源性疼痛。
譯文內容由第三人軟體翻譯。