Integra’s DuraSeal® Dural Sealant Saves Healthcare Costs According to an Economic Evaluation Published in the Journal of Comparative Effectiveness Research
A new economic study published in the Journal of Comparative Effectiveness Research demonstrates significant cost savings when using Integra's DuraSeal Polyethylene Glycol (PEG) hydrogel instead of fibrin glue in posterior cranial fossa surgeries. The analysis, conducted across five European countries (Belgium, France, Germany, Italy, and UK), shows cost savings ranging from €419 to €1,279 per patient, representing an average 22% cost reduction per procedure (15% in Italy).
The study is based on a prospective observational study of 200 patients and reveals that DuraSeal's effectiveness at preventing cerebrospinal fluid (CSF) leaks leads to reduced hospital stays and fewer post-surgical interventions. Despite higher upfront costs, DuraSeal proves to be a cost-effective alternative to fibrin glue in PCF surgery across European healthcare systems.
Un nuovo studio economico pubblicato nel Journal of Comparative Effectiveness Research dimostra un significativo risparmio dei costi utilizzando il DuraSeal Polyethylene Glycol (PEG) hydrogel di Integra anziché la colla fibrinica nelle chirurgie della fossa cranica posteriore. L'analisi, condotta in cinque paesi europei (Belgio, Francia, Germania, Italia e Regno Unito), mostra risparmi che variano da €419 a €1,279 per paziente, rappresentando una riduzione media dei costi del 22% per procedura (15% in Italia).
Lo studio si basa su uno studio osservazionale prospettico di 200 pazienti e rivela che l'efficacia di DuraSeal nel prevenire le perdite di liquido cerebrospinale (CSF) porta a una riduzione dei tempi di ricovero e a meno interventi post-chirurgici. Nonostante i costi iniziali più elevati, DuraSeal si dimostra un'alternativa economicamente vantaggiosa alla colla fibrinica nella chirurgia della fossa cranica posteriore nei sistemi sanitari europei.
Un nuevo estudio económico publicado en el Journal of Comparative Effectiveness Research demuestra importantes ahorros de costos al usar el DuraSeal Polyethylene Glycol (PEG) hydrogel de Integra en lugar de la cola de fibrina en operaciones de fosa craneal posterior. El análisis, realizado en cinco países europeos (Bélgica, Francia, Alemania, Italia y Reino Unido), muestra ahorros que oscilan entre €419 y €1,279 por paciente, lo que representa una reducción media del 22% en los costos por procedimiento (15% en Italia).
El estudio se basa en un estudio observacional prospectivo de 200 pacientes y revela que la efectividad de DuraSeal para prevenir fugas de líquido cefalorraquídeo (CSF) conduce a estancias hospitalarias más cortas y menos intervenciones postquirúrgicas. A pesar de los costos iniciales más altos, DuraSeal resulta ser una alternativa rentable a la cola de fibrina en la cirugía de la fosa craneal posterior en los sistemas de salud europeos.
비교 효과 연구 저널에 발표된 새로운 경제 연구는 Integra의 DuraSeal Polyethylene Glycol (PEG) 하이드로젤을 사용했을 때 후두부 수술에서 피브린 접착제 대신 상당한 비용 절감 효과를 입증합니다. 벨기에, 프랑스, 독일, 이탈리아, 영국 등 5개 유럽 국가에서 실시된 분석에 따르면, 환자당 €419에서 €1,279까지의 비용 절감이 이루어지며, 이는 평균 22%의 비용 절감(이탈리아 15%)을 나타냅니다.
이 연구는 200명의 환자를 대상으로 한 전향적 관찰 연구를 바탕으로 하며, DuraSeal의 뇌척수액(CSF) 누출 방지 효과가 병원에 머무는 시간을 줄이고 수술 후 중재를 감소시킴을 보여줍니다. 초기 비용은 더 높지만, DuraSeal은 유럽의 의료 시스템에서 후두부 수술에 있어 피브린 접착제에 대한 비용 효과적인 대안으로 입증됩니다.
Une nouvelle étude économique publiée dans le Journal of Comparative Effectiveness Research démontre des économies de coûts significatives en utilisant le DuraSeal Polyethylene Glycol (PEG) hydrogel d'Integra plutôt que la colle de fibrine lors des opérations de la fosse crânienne postérieure. L'analyse, réalisée dans cinq pays européens (Belgique, France, Allemagne, Italie et Royaume-Uni), montre des économies allant de €419 à €1,279 par patient, représentant une réduction moyenne des coûts de 22 % par procédure (15 % en Italie).
Cette étude est basée sur une étude d'observation prospective de 200 patients et révèle que l'efficacité de DuraSeal à prévenir les fuites de liquide céphalorachidien (CSF) entraîne des séjours hospitaliers plus courts et moins d'interventions post-chirurgicales. Malgré des coûts initiaux plus élevés, DuraSeal se révèle être une alternative économiquement viable à la colle de fibrine dans la chirurgie de la fosse crânienne postérieure dans les systèmes de santé européens.
Eine neue Wirtschaftsstudie, die im Journal of Comparative Effectiveness Research veröffentlicht wurde, zeigt signifikante Kosteneinsparungen bei der Verwendung von Integra's DuraSeal Polyethylene Glycol (PEG) Hydrogel anstelle von Fibrinkleber bei Operationen im hinteren Schädelgrubenbereich. Die Analyse, die in fünf europäischen Ländern (Belgien, Frankreich, Deutschland, Italien und Großbritannien) durchgeführt wurde, zeigt Kosteneinsparungen von €419 bis €1,279 pro Patient, was einer durchschnittlichen Kostenreduzierung von 22 % pro Eingriff (15 % in Italien) entspricht.
Die Studie basiert auf einer prospektiven Beobachtungsstudie mit 200 Patienten und zeigt, dass die Wirksamkeit von DuraSeal zur Verhinderung von Liquorlecks (CSF) zu verkürzten Krankenhausaufenthalten und weniger postoperativen Eingriffen führt. Trotz höherer Anfangskosten erweist sich DuraSeal als kosteneffektive Alternative zu Fibrinkleber in der Schädelgruben-Hinteroperation in den europäischen Gesundheitssystemen.
- None.
- None.
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
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
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
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
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.
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.”
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.
“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.”
Abstract of the analysis and the full analysis can be found here
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 www.integralife.com
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.
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”.
DuraSeal® cranial sealant system is CE class III devices in Europe.
Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions.
2787
Legal manufacturer: Integra LifeSciences Corporation also dba Integra NeuroSciences, 1100 Campus Rd., Princeton, New Jersey 08540, USA
EC REP : Integra LifeSciences Services (France) Immeuble Séquoia 2 - 97, allée Alexandre Borodine, Parc technologique de la Porte des Alpes 69800 Saint-Priest France
Forward-Looking Statements
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.
Contact:
Media (Europe)
Marion Vincent
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
Investor Relations
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.
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.
3 Neurosurgery Ospedale Niguarda Ca’ Granda
4 International Neurosurgical Practice
5 Coreva Scientific GmbH & Co. KG
6 Integra LifeSciences
7 Strategic Solutions, Inc.
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).
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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/c007cf36-2739-41bf-b669-9f5059c00358
FAQ
What are the cost savings of using DuraSeal compared to fibrin glue according to the 2024 European study?
How many countries were included in the 2024 DuraSeal economic evaluation study for IART?
What clinical benefits does DuraSeal offer in posterior cranial fossa surgeries?
How many patients were included in the observational study supporting the 2024 DuraSeal economic analysis?
