Integra's DuraSeal Dural Sealant Saves Healthcare Costs According to an Economic Evaluation Published in the Journal of Comparative Effectiveness Research
Integra's DuraSeal Dural Sealant Saves Healthcare Costs According to an Economic Evaluation Published in the Journal of Comparative Effectiveness Research
The health economic analysis, conducted in five European countries, shows that hospitals can reduce costs of cerebrospinal fluid leaks after posterior cranial fossa surgeries by using DuraSeal dural sealant instead of fibrin glue
在五個歐洲國家進行的健康經濟分析表明,醫院通過使用DuraSeal膜密封膠而非纖維膠,可以減少後方顱窩手術後腦脊液泄漏的成本。
PRINCETON, N.J., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today announced the publication of a new economic study, "PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: An economic comparison across five European countries."1
新澤西州普林斯頓,2024年11月13日(環球新聞網)-- 英特格拉生命科學控股公司(納斯達克:IART),一家領先的全球醫療科技公司,今天宣佈發佈一項新的經濟研究,題爲"PEG水凝膠密封膠與纖維膠在後方顱窩手術中的經濟比較:跨五個歐洲國家的經濟比較。"
The purpose of this evaluation was to assess the budget-impact of switching patient treatment from fibrin glue to DuraSeal Polyethylene Glycol (PEG) hydrogel in five major European countries: Belgium, France, Germany, Italy, and the United Kingdom. The evaluation demonstrates an average cost savings of €419 to €1,279 per patient, when using Integra's DuraSeal PEG dural sealant hydrogel instead of fibrin glue. Depending on the country, consistent cost reduction per procedure averaged around 22%, except for Italy where the analysis resulted in 15% consistent cost reduction per procedure.
本次評估的目的是評估在五個主要歐洲國家(比利時、法國、德國、意大利和英國)將患者治療從纖維膠轉變爲DuraSeal聚乙烯醇(PEG)水凝膠的預算影響。評估顯示,使用英特格拉的DuraSeal PEG膜密封膠而非纖維膠,每位患者的平均成本節省爲€419至€1,279。根據不同國家,手術每次的成本減少平均約爲22%,意大利的分析結果顯示每次手術的成本減少爲15%。
Cerebrospinal fluid (CSF) leaks after posterior cranial fossa (PCF) surgery are a significant cause of longer hospital stays, hospital readmissions and other costly post-surgical interventions. Current practice to seal the operative site after primary closure aid the healing process and protect the patient from CSF leaks widely relies on either fibrin glue or PEG hydrogel.2
後方顱窩(PCF)手術後的腦脊液(CSF)泄漏是導致住院時間延長、醫院再入院和其他昂貴的術後干預的重要原因。當前對手術部位進行密封以促進癒合並保護患者免受腦脊液泄漏的做法,普遍依賴於纖維膠或PEG水凝膠。
The analysis, published in the Journal of Comparative Effectiveness Research in February 2024, was conducted by Giuseppe Talamonti3, Jorn-Andre Horaczek4, Rafael Torrejon Torres5, Lisa Da Deppo6 and Marissa J Carter7. This economic analysis is based on a peer-reviewed prospective observational study of 200 patients that found PEG hydrogel was associated with positive clinical outcomes of PEG-based hydrogels8 compared to fibrin glue in PCF surgeries. A decision tree was developed on a previous U.S. model9 and input costs that were derived from European country-specific published sources. The results demonstrated that the clinical effectiveness of Integra's DuraSeal Dural Sealant at preventing CSF leaks compared to fibrin glue after PCF surgery may help hospitals reduce costs.
該分析於2024年2月發表在《比較效果研究期刊》中,由Giuseppe Talamonti、Jorn-Andre Horaczek、Rafael Torrejon Torres、Lisa Da Deppo和Marissa J Carter進行。這項經濟分析是基於一項對200名患者進行的同行評審前瞻性觀察研究,該研究發現,和PCF手術中的纖維膠相比,PEG水凝膠與積極的臨床結果相關。基於之前的美國模型開發了決策樹,輸入成本來源於特定歐洲國家的公開數據。結果表明,英特格拉的DuraSeal膜密封膠在防止PCF手術後腦脊液泄漏方面的臨床效果優於纖維膠,可能幫助醫院降低成本。
Marissa Carter, PhD, MA, president of Strategic Solutions, a consultancy specializing in clinical trials and real-world data health economic studies, said "This follow-up health economics study in the use of PEG hydrogel as a dural sealant to prevent CSF leaks and other complications resulting from PCF surgery is very timely. Most of all, it is gratifying to see the original model developed in the United States now successfully applied to five European countries in which cost savings are also demonstrated. Thanks to this collaboration between the manufacturer and clinicians, it is hopeful that these results will enable greater access to DuraSeal for patients undergoing surgery."
馬裏薩·卡特,博士,碩士,戰略解決方案公司的總裁,該公司專門從事臨床試驗和真實世界數據的健康經濟研究,她表示:「在使用PEG水凝膠作爲硬膜密封膠以防止腦脊液泄漏和其他由於PCF手術引起的併發症的後續健康經濟研究是非常及時的。最重要的是,看到最初在美國開發的模型現在成功應用於五個歐洲國家,並且證明了成本節約,這讓我感到欣慰。感謝製造商與臨床醫生之間的合作,我們希望這些結果能使進行手術的患者更大程度地獲得DuraSeal。」
DuraSeal can be a viable, cost-effective alternative to fibrin glue in PCF surgery in Europe. As a direct consequence of the decreased occurrence of adverse CSF leaks and related complications, DuraSeal, despite its higher up-front cost, reduces overall PCF operative spend.
DuraSeal可以作爲歐洲PCF手術中纖維膠的一種可行且具成本效益的替代品。由於減少了不良腦脊液泄漏及相關併發症的發生,儘管DuraSeal的前期成本較高,但它降低了總體的PCF手術支出。
"This recently published economic evaluation supports DuraSeal in the management of PCF surgery to our customers, providing strong evidence for healthcare professionals to reduce CSF leaks and cost-saving improvement for hospitals and healthcare systems," said Harvinder Singh, Integra's executive vice president and president, International. "This study outcome reinforces our commitment to our neuro access & repair strategy, innovating new treatment pathways, and restoring patient lives through technologies that transform surgical care."
"這項最近發佈的經濟評估支持DuraSeal在PCF手術管理中的應用,爲醫療保健專業人員減少腦脊液泄漏和爲醫院及醫療系統實現成本節約提供了有力證據,"英特格拉生命科學的執行副總裁及國際總裁哈文德·辛格表示。"這項研究結果加強了我們對神經通路與修復策略的承諾,創新新的治療途徑,通過轉變外科護理的科技來恢復患者的生命。"
Abstract of the analysis and the full analysis can be found here
分析的摘要和完整分析可以在這裏找到
About Integra LifeSciences
At Integra LifeSciences, we are driven by our purpose of restoring patients' lives. We innovate treatment pathways to advance patient outcomes and set new standards of surgical, neurologic and regenerative care. We offer a comprehensive portfolio of high quality, leadership brands. For the latest news and information about Integra and its products, please visit
關於英特格拉生命科學
在英特格拉生命科學,我們的使命是恢復患者的生命。我們創新治療方案以改善患者的結果,並設定外科、神經和再生護理的新標準。我們提供高質量、領導品牌的綜合產品組合。有關英特格拉及其產品的最新資訊和信息,請訪問
About Integra DuraSeal Dural Sealant System
The DuraSeal Dural Sealant System is intended for use as an adjunct to standard methods of dural repair as sutures to provide watertight closure.
關於英特格拉DuraSeal硬膜密封膠系統
DuraSeal硬膜密封膠系統旨在作爲標準硬膜修復方法的輔助工具,與縫合一起使用,以提供防水密閉。
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. All the medical devices mentioned on this document are CE marked in accordance with the applicable European laws, unless specifically identified as "NOT CE MARKED".
這些產品的可用性可能因特定國家或地域的法規批准或清關要求而有所不同。本文檔中提到的所有醫療設備均按照適用的歐洲法律標註CE標記,除非特別標識爲"未標記CE"。
DuraSeal cranial sealant system is CE class III devices in Europe.
DuraSeal顱骨密封膠系統是歐洲的CE III類醫療設備。
Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions.
請查閱產品標籤和說明書以了解任何適應症、禁忌症、風險、警告和注意事項。
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Legal manufacturer: Integra LifeSciences Corporation also dba Integra NeuroSciences, 1100 Campus Rd., Princeton, New Jersey 08540, USA
合法製造商:英特格拉生命科學公司(Integra LifeSciences Corporation),又名英特格拉神經科學(Integra NeuroSciences),地址:1100 Campus Rd., Princeton, New Jersey 08540, 美國。
EC REP : Integra LifeSciences Services (France) Immeuble Séquoia 2 - 97, allée Alexandre Borodine, Parc technologique de la Porte des Alpes 69800 Saint-Priest France
EC REP: 英特格拉生命科學服務(法國) Immeuble Séquoia 2 - 97, allée Alexandre Borodine, Parc technologique de la Porte des Alpes 69800 Saint-Priest France
Forward-Looking Statements
前瞻性聲明
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to, the improved clinical effectiveness and cost savings of Integra's DuraSeal PEG hydrogel in PCF surgery. There can be no assurance that the clinical benefits and cost savings described herein will be replicated. The actual effect of the use of this product can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that this product will be commercially successful or achieve any level of sales for use in PCF surgery. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Integra's business and market, particularly those identified under the heading "Risk Factors" included in item 1A of Integra's Annual Report on Form 10-K for the year ended December 31, 2023, and information contained in subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and Integra undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
本新聞稿包含1995年《私人證券訴訟改革法》的定義下的前瞻性聲明。這些前瞻性聲明涉及可能導致實際結果與預測結果不同的風險和不確定性。可能討論的前瞻性因素包括,但不限於,英特格拉的DuraSeal PEG水凝膠在PCF手術中的臨床有效性和成本節約的改善。無法保證此處描述的臨床利益和成本節約將會被複制。該產品的實際效果只能根據特定情況和相關患者逐案確定。此外,無法保證該產品將在PCF手術中取得商業成功或實現任何銷售水平。本新聞稿中的前瞻性聲明應與影響英特格拉業務和市場的衆多風險和不確定性共同評估,特別是與2023年12月31日結束的年度報告中的「風險因素」標題下識別的那些,以及隨後的證券交易委員會備案中的信息。這些前瞻性聲明僅在其日期上作出,且英特格拉沒有義務更新或修訂這些前瞻性聲明,無論是由於新信息、未來事件還是其他原因,除非適用法律要求。
Contact:
聯繫方式:
Media (Europe)
Marion Vincent
00 33 (0)6 47 84 64 82
marion.vincent@integralife.com
媒體(歐洲)
瑪麗昂·文森特
00 33 (0)6 47 84 64 82
marion.vincent@integralife.com
Media (U.S.)
Laurene Isip
+1 609 208 8121
laurene.isip@integralife.com
媒體(美國)
Laurene Isip
+1 609 208 8121
laurene.isip@integralife.com
Investor Relations
Chris Ward
+1 609 772 7736
chris.ward@integralife.com
投資者關係
Chris Ward
+1 609 772 7736
chris.ward@integralife.com
1 Talamonti G, Horaczek JA, Torres RT, Deppo LD, Carter MJ. PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: an economic comparison across five European countries. J Comp Eff Res. 2024 Apr;13(4):e230047.
1 Talamonti G, Horaczek JA, Torres Rt, Deppo LD, Carter MJ. PEG水凝膠密封膠與纖維蛋白膠在後顱窩手術中的經濟比較:跨五個歐洲國家的研究。J Comp Eff Res. 2024年4月;13(4):e230047。
2 Wright NM, Park J, Tew JM, et al. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine. 2015;40(8):505-513.
2 Wright Nm, Park J, Tew Jm, 等。脊柱密封系統在脊柱手術中提供比標準護理更好的術中防水閉合:一項前瞻性、多中心、隨機對照研究。脊柱. 2015;40(8):505-513。
3 Neurosurgery Ospedale Niguarda Ca' Granda
3 神經外科 Ospedale Niguarda Ca' Granda
4 International Neurosurgical Practice
4 國際神經外科實踐
5 Coreva Scientific GmbH & Co. KG
5 科瑞瓦科學公司
6 Integra LifeSciences
6 英特格拉生命科學
7 Strategic Solutions, Inc.
7 策略解決方案公司
8 Than KD, Baird CJ, Olivi A. Polyethylene glycol hydrogel dural sealant may reduce incisional cerebrospinal fluid leak after posterior fossa surgery. Neurosurgery. 2008 Jul;63(1 Suppl 1).
8 Than KD, Baird CJ, Olivi A. 聚乙烯醇水凝膠硬膜密封膠可能減少後顱窩手術後的切口腦脊液泄漏。神經外科。2008年7月;63(1補充1)。
9 Carter MJ. A Cost-benefit Analysis of Using Polyethylene Glycol Hydrogel Sealant versus Fibrin Glue as a Dural Sealant for Posterior Fossa Surgery in the United States. J Health Econ Outcomes Res. 2017 Aug 9;5(2):125-139.
9 Carter MJ. 一項關於在美國進行後顱窩手術時使用聚乙烯醇水凝膠密封膠與纖維蛋白膠作爲硬膜密封膠的成本效益分析。健康經濟學與結果研究雜誌。2017年8月9日;5(2):125-139。
A photo accompanying this announcement is available at
本公告附有一張照片。
譯文內容由第三人軟體翻譯。