The well being financial evaluation, carried out in 5 European international locations, exhibits that hospitals can cut back prices of cerebrospinal fluid leaks after posterior cranial fossa surgical procedures through the use of DuraSeal dural sealant as a substitute of fibrin glue
PRINCETON, N.J., Nov. 13, 2024 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Company (Nasdaq: IART), a number one world medical expertise firm, right now introduced the publication of a brand new financial research, “PEG hydrogel sealant versus fibrin glue in posterior fossa surgical procedure: An financial comparability throughout 5 European international locations.”1
The aim of this analysis was to evaluate the budget-impact of switching affected person therapy from fibrin glue to DuraSeal Polyethylene Glycol (PEG) hydrogel in 5 main European international locations: Belgium, France, Germany, Italy, and the UK. The analysis demonstrates a mean price financial savings of €419 to €1,279 per affected person, when utilizing Integra’s DuraSeal PEG dural sealant hydrogel as a substitute of fibrin glue. Relying on the nation, constant price discount per process averaged round 22%, apart from Italy the place the evaluation resulted in 15% constant price discount per process.
Cerebrospinal fluid (CSF) leaks after posterior cranial fossa (PCF) surgical procedure are a major explanation for longer hospital stays, hospital readmissions and different pricey post-surgical interventions. Present observe to seal the operative web site after main closure help the therapeutic course of and defend the affected person from CSF leaks broadly depends on both fibrin glue or PEG hydrogel.2
The evaluation, revealed within the Journal of Comparative Effectiveness Analysis in February 2024, was carried out by Giuseppe Talamonti3, Jorn-Andre Horaczek4, Rafael Torrejon Torres5, Lisa Da Deppo6 and Marissa J Carter7. This financial evaluation relies on a peer-reviewed potential observational research of 200 sufferers that discovered PEG hydrogel was related to optimistic medical outcomes of PEG-based hydrogels8 in comparison with fibrin glue in PCF surgical procedures. A call tree was developed on a earlier U.S. mannequin9 and enter prices that have been derived from European country-specific revealed sources. The outcomes demonstrated that the medical effectiveness of Integra’s DuraSeal Dural Sealant at stopping CSF leaks in comparison with fibrin glue after PCF surgical procedure could assist hospitals cut back prices.
Marissa Carter, PhD, MA, president of Strategic Options, a consultancy specializing in medical trials and real-world knowledge well being financial research, stated “This follow-up well being economics research in the usage of PEG hydrogel as a dural sealant to forestall CSF leaks and different issues ensuing from PCF surgical procedure could be very well timed. Most of all, it’s gratifying to see the unique mannequin developed in the USA now efficiently utilized to 5 European international locations during which price financial savings are additionally demonstrated. Because of this collaboration between the producer and clinicians, it’s hopeful that these outcomes will allow better entry to DuraSeal for sufferers present process surgical procedure.”
DuraSeal is usually a viable, cost-effective various to fibrin glue in PCF surgical procedure in Europe. As a direct consequence of the decreased incidence of hostile CSF leaks and associated issues, DuraSeal, regardless of its larger up-front price, reduces general PCF operative spend.
“This lately revealed financial analysis helps DuraSeal within the administration of PCF surgical procedure to our prospects, offering robust proof for healthcare professionals to cut back CSF leaks and cost-saving enchancment for hospitals and healthcare methods,” stated Harvinder Singh, Integra’s government vp and president, Worldwide. “This research consequence reinforces our dedication to our neuro entry & restore technique, innovating new therapy pathways, and restoring affected person lives by applied sciences that rework surgical care.”
Summary of the evaluation and the complete evaluation could be discovered right here
About Integra LifeSciences
At Integra LifeSciences, we’re pushed by our goal of restoring sufferers’ lives. We innovate therapy pathways to advance affected person outcomes and set new requirements of surgical, neurologic and regenerative care. We provide a complete portfolio of top of the range, management manufacturers. For the most recent information and details about Integra and its merchandise, please go to www.integralife.com
About Integra DuraSeal® Dural Sealant System
The DuraSeal® Dural Sealant System is meant to be used as an adjunct to plain strategies of dural restore as sutures to supply watertight closure.
Availability of those merchandise would possibly fluctuate from a given nation or area to a different, because of particular native regulatory approval or clearance necessities on the market in such nation or area. All of the medical gadgets talked about on this doc are CE marked in accordance with the relevant European legal guidelines, until particularly recognized as “NOT CE MARKED”.
DuraSeal® cranial sealant system is CE class III gadgets in Europe.
Seek the advice of product labels and inserts for any indications, contraindications, hazards, warnings, precautions.
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Authorized producer: Integra LifeSciences Company additionally dba Integra NeuroSciences, 1100 Campus Rd., Princeton, New Jersey 08540, USA
EC REP : Integra LifeSciences Providers (France) Immeuble Séquoia 2 – 97, allée Alexandre Borodine, Parc technologique de la Porte des Alpes 69800 Saint-Priest France
Ahead-Trying Statements
This information launch comprises forward-looking statements inside the which means of the Non-public Securities Litigation Reform Act of 1995. Such forward-looking statements contain dangers and uncertainties that might trigger precise outcomes to vary from predicted outcomes. Ahead-looking elements which may be mentioned embody, however will not be restricted to, the improved medical effectiveness and value financial savings of Integra’s DuraSeal PEG hydrogel in PCF surgical procedure. There could be no assurance that the medical advantages and value financial savings described herein might be replicated. The precise impact of the usage of this product can solely be decided on a case-by-case foundation relying on the actual circumstances and affected person in query. As well as, there could be no assurance that this product might be commercially profitable or obtain any stage of gross sales to be used in PCF surgical procedure. Ahead-looking statements on this press launch must be evaluated along with the various dangers and uncertainties that have an effect on Integra’s enterprise and market, significantly these recognized underneath the heading “Danger Components” included in merchandise 1A of Integra’s Annual Report on Kind 10-Okay for the yr ended December 31, 2023, and data contained in subsequent filings with the Securities and Change Fee. These forward-looking statements are made solely because the date thereof, and Integra undertakes no obligation to replace or revise the forward-looking statements, whether or not because of new data, future occasions or in any other case, besides as required by relevant legislation.
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 surgical procedure: an financial comparability throughout 5 European international locations. J Comp Eff Res. 2024 Apr;13(4):e230047.
2 Wright NM, Park J, Tew JM, et al. Spinal sealant system offers higher intraoperative watertight closure than normal of care throughout spinal surgical procedure: a potential, multicenter, randomized managed research. Backbone. 2015;40(8):505-513.
3 Neurosurgery Ospedale Niguarda Ca’ Granda
4 Worldwide Neurosurgical Follow
5 Coreva Scientific GmbH & Co. KG
6 Integra LifeSciences
7 Strategic Options, Inc.
8 Than KD, Baird CJ, Olivi A. Polyethylene glycol hydrogel dural sealant could cut back incisional cerebrospinal fluid leak after posterior fossa surgical procedure. Neurosurgery. 2008 Jul;63(1 Suppl 1).
9 Carter MJ. A Price-benefit Evaluation of Utilizing Polyethylene Glycol Hydrogel Sealant versus Fibrin Glue as a Dural Sealant for Posterior Fossa Surgical procedure in the USA. J Health Econ Outcomes Res. 2017 Aug 9;5(2):125-139.
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