Baxter Launches New Room Temperature Hemopatch Sealing Hemostat for Rapid and Convenient Application During Surgery
Baxter International Inc. (NYSE:BAX) has announced the launch of an enhanced version of Hemopatch Sealing Hemostat that can now be stored at room temperature in Europe. This evolution eliminates the need for refrigeration, making the product more accessible in operating rooms for immediate use during critical situations.
Hemopatch Sealing Hemostat is a ready-to-use absorbable collagen pad designed for tissue sealing, dura sealing, and hemostasis in both open and minimally invasive surgeries. The product consists of a soft, flexible collagen pad derived from bovine dermis, coated with NHS-PEG, and features blue squares on the non-coated side for differentiation.
According to real-world data across Europe, the product has demonstrated effectiveness in achieving rapid and sustainable hemostasis across various surgical specialties. This product enhancement is a result of collaboration between surgeons and Baxter, addressing the critical need for immediate access during surgical procedures.
Baxter International Inc. (NYSE:BAX) ha annunciato il lancio di una versione migliorata dell'emostatico Hemopatch Sealing Hemostat, che ora può essere conservato a temperatura ambiente in Europa. Questa evoluzione elimina la necessità di refrigerazione, rendendo il prodotto più accessibile nelle sale operatorie per un uso immediato durante situazioni critiche.
Hemopatch Sealing Hemostat è un pad di collagene assorbibile pronto all'uso, progettato per la sigillatura dei tessuti, la sigillatura della dura e l'emostasi sia in interventi chirurgici aperti che minimamente invasivi. Il prodotto è composto da un pad di collagene morbido e flessibile derivato dal derma bovino, rivestito con NHS-PEG, e presenta quadrati blu sul lato non rivestito per facilitarne la differenziazione.
Secondo i dati reali provenienti da tutta Europa, il prodotto ha dimostrato efficacia nel raggiungere un'emostasi rapida e sostenibile in varie specialità chirurgiche. Questo miglioramento del prodotto è il risultato di una collaborazione tra chirurghi e Baxter, che ha risposto all'urgente necessità di accesso immediato durante le procedure chirurgiche.
Baxter International Inc. (NYSE:BAX) ha anunciado el lanzamiento de una versión mejorada del hemostático Hemopatch Sealing Hemostat, que ahora puede almacenarse a temperatura ambiente en Europa. Esta evolución elimina la necesidad de refrigeración, lo que hace que el producto sea más accesible en las salas de operaciones para su uso inmediato durante situaciones críticas.
Hemopatch Sealing Hemostat es un pad de colágeno absorbible listo para usar, diseñado para el sellado de tejidos, el sellado de la dura y la hemostasia en cirugías abiertas y mínimamente invasivas. El producto consiste en un pad de colágeno suave y flexible derivado de la dermis bovina, recubierto con NHS-PEG, y presenta cuadrados azules en el lado no recubierto para su diferenciación.
Según datos del mundo real en toda Europa, el producto ha demostrado efectividad en lograr una hemostasia rápida y sostenible en diversas especialidades quirúrgicas. Esta mejora del producto es el resultado de la colaboración entre cirujanos y Baxter, que aborda la necesidad crítica de acceso inmediato durante los procedimientos quirúrgicos.
박스터 인터내셔널 주식회사 (NYSE:BAX)는 이제 유럽에서 실온에서 보관할 수 있는 Hemopatch Sealing Hemostat의 개선된 버전을 출시했다고 발표했습니다. 이 발전은 냉장이 필요 없게 하여, 긴급 상황에서 즉시 사용할 수 있도록 수술실에서 제품 접근성을 높입니다.
Hemopatch Sealing Hemostat은 조직 봉합, 경막 봉합 및 개방형 및 최소 침습 수술에서의 지혈을 위해 설계된 사용 준비가 완료된 흡수성 콜라겐 패드입니다. 이 제품은 소의 진피에서 유래된 부드럽고 유연한 콜라겐 패드로, NHS-PEG로 코팅되어 있으며, 비코팅된 면에는 구별을 위해 파란색 사각형이 있습니다.
유럽 전역의 실제 데이터에 따르면, 이 제품은 다양한 외과 전문 분야에서 빠르고 지속 가능한 지혈을 달성하는 데 효과적임을 입증했습니다. 이 제품 개선은 외과의사와 박스터 간의 협력의 결과로, 수술 절차 중 즉각적인 접근의 긴급한 필요성을 해결하고 있습니다.
Baxter International Inc. (NYSE:BAX) a annoncé le lancement d'une version améliorée de l'hémostatique Hemopatch Sealing Hemostat, qui peut désormais être stockée à température ambiante en Europe. Cette évolution élimine le besoin de réfrigération, rendant le produit plus accessible dans les salles d'opération pour une utilisation immédiate lors de situations critiques.
Hemopatch Sealing Hemostat est un pad de collagène absorbable prêt à l'emploi, conçu pour le scellement des tissus, le scellement de la dure et l'hémostase lors de chirurgies ouvertes et minimales. Le produit se compose d'un pad de collagène doux et flexible dérivé du derme bovin, recouvert de NHS-PEG, et présente des carrés bleus sur le côté non recouvert pour la différenciation.
Selon des données du monde réel à travers l'Europe, le produit a démontré son efficacité à atteindre une hémostase rapide et durable dans diverses spécialités chirurgicales. Cette amélioration du produit est le résultat d'une collaboration entre des chirurgiens et Baxter, répondant à la nécessité critique d'un accès immédiat lors des procédures chirurgicales.
Baxter International Inc. (NYSE:BAX) hat die Einführung einer verbesserten Version des Hemostatikums Hemopatch Sealing Hemostat angekündigt, die jetzt in Europa bei Raumtemperatur gelagert werden kann. Diese Entwicklung beseitigt die Notwendigkeit der Kühlung und macht das Produkt in Operationssälen für den sofortigen Einsatz in kritischen Situationen zugänglicher.
Hemopatch Sealing Hemostat ist ein gebrauchsfertiges, absorbierbares Kollagenpad, das für das Gewebesiegeln, das Dura-Siegeln und die Hämostase sowohl bei offenen als auch bei minimalinvasiven Eingriffen entwickelt wurde. Das Produkt besteht aus einem weichen, flexiblen Kollagenpad, das aus der bovinen Dermis gewonnen wird, mit NHS-PEG beschichtet ist und auf der nicht beschichteten Seite blaue Quadrate zur Unterscheidung aufweist.
Nach realen Daten aus ganz Europa hat das Produkt seine Wirksamkeit bei der Erreichung einer schnellen und nachhaltigen Hämostase in verschiedenen chirurgischen Fachrichtungen unter Beweis gestellt. Diese Produktverbesserung ist das Ergebnis einer Zusammenarbeit zwischen Chirurgen und Baxter, die den kritischen Bedarf an sofortigem Zugang während chirurgischer Eingriffe anspricht.
- Product improvement eliminates refrigeration requirements, reducing storage costs
- Enhanced accessibility in operating rooms could drive increased adoption
- Demonstrated effectiveness in real-world data across European markets
- to European market availability only
- Faces competition in the surgical hemostat market
Insights
Baxter's introduction of room temperature storage for their Hemopatch Sealing Hemostat represents a meaningful enhancement in surgical hemostasis technology. The elimination of refrigeration requirements directly addresses a critical operational challenge in surgical settings where immediate access to hemostatic agents can significantly impact patient outcomes.
From a clinical perspective, this modification offers two substantial advantages: first, it enables direct accessibility in operating rooms without retrieval from refrigerated storage, potentially reducing critical time delays during bleeding complications; second, it likely extends shelf-life stability which reduces waste from expired products – a common issue with temperature-sensitive surgical materials.
What's particularly notable is that this innovation stems from collaborative efforts with practicing surgeons rather than being a purely internal R&D initiative. This user-driven development typically produces modifications with higher clinical utility. The product's documented efficacy across multiple surgical specialties in real-world registry data further strengthens its value proposition.
The expanded functionality for both open and minimally invasive procedures positions this product well in today's surgical environment where less invasive approaches continue gaining prominence. While seemingly incremental, enhancements to storage conditions can significantly influence adoption patterns among surgical teams by removing logistical barriers that previously constrained utilization.
This product enhancement represents a strategic optimization of Baxter's established hemostatic portfolio rather than a revolutionary new offering. By eliminating refrigeration requirements, Baxter addresses a key adoption barrier while likely extending product shelf-life – both factors that could incrementally improve sales performance in the European surgical markets.
While financial impact isn't quantified, this evolution demonstrates sound lifecycle management for a mature product that's been in the market for over a decade. The timing is particularly relevant as hospitals increasingly scrutinize both clinical efficacy and operational efficiency of medical supplies.
The competitive landscape for surgical hemostats remains intense, with multiple players offering various sealing technologies. Baxter's enhancement helps protect their existing market position by addressing specific user needs articulated through surgeon collaborations. This customer-centric approach to product evolution typically yields better commercial outcomes than technology-driven innovations disconnected from clinical workflow realities.
For investors, this represents continued innovation within Baxter's Advanced Surgery segment, though the materiality to overall corporate performance is likely modest given the company's diversified portfolio. Nevertheless, these types of incremental improvements across multiple product lines collectively contribute to maintaining competitive positioning in core markets, particularly important as Baxter continues navigating broader corporate challenges.
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Hemopatch Sealing Hemostat with room temperature storage now available in
Europe - New product evolution enables direct accessibility in the operating room
- Innovation is a direct result of collaborative efforts with surgeons, helping to ensure that customer needs are met and promoting enhanced patient care
“For over a decade, Hemopatch Sealing Hemostat has offered surgeons a reliable solution for tissue sealing, dura sealing, and hemostasis,” said Steve Wallace, president, Advanced Surgery at Baxter. “The product evolution to include room temperature storage is a result of close collaboration between surgeons and Baxter. Removing the need for refrigeration addresses the needs of our customers to have the product on hand in critical situations. We are proud to continue Baxter's legacy of innovation in sealing and hemostasis.”
Hemopatch Sealing Hemostat is a ready-to-use absorbable collagen pad intended for tissue sealing, dura sealing and hemostasis, and is effective and safe to use in open surgery and minimally invasive surgery. In a registry of real-world data across
General Surgeon, Prof. Dr. med. Selman Uranüs said, “More than 10 years ago, I first used Hemopatch Sealing Hemostat for experimental testing. Since then, I have been using it in my daily practice because of its unique characteristics as a sealing hemostatic patch, especially in laparoscopic surgery. In my opinion, eliminating the need for refrigeration and increasing product shelf life are crucial improvements because it enables surgeons to have the product available in the operating room when it matters most. After application, the product shows an enhanced adhesive strength supporting us surgeons to achieve better surgical outcomes.”2
For more information on Hemopatch Sealing Hemostat with room temperature storage, visit https://advancedsurgery.baxter.eu/hemopatch
About Hemopatch Sealing Hemostat
Hemopatch Sealing Hemostat consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of Hemopatch Sealing Hemostat to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant.3
About Baxter
Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X, LinkedIn and Facebook.
INDICATIONS
Hemopatch Sealing Hemostat is indicated as a hemostatic device and surgical sealant across various soft tissues (cardiovascular, connective tissue, parenchyma, serosa, viscera), and dura for procedures in which control of mild or moderate bleeding or leakage of other body fluids or air by conventional surgical techniques is either ineffective or impractical. Hemopatch Sealing Hemostat may be used to augment dura closure techniques to close small dural defects (≤3mm) following traumatic injury, excision, retraction or shrinkage of the dura mater.
IMPORTANT RISK INFORMATION
- Hemopatch Sealing Hemostat is not recommended to be used in pulsatile, severe bleedings.
- The use of Hemopatch Sealing Hemostat is not recommended in the presence of an active infection.
- When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, the brain and/or cranial nerves, care should be exercised to avoid overpacking as Hemopatch Sealing Hemostat may expand upon absorption of liquid, creating the potential for neural damage.
- Hemopatch Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis and sealing.
- Do not compress Hemopatch Sealing Hemostat into blood vessels or use intravascularly.
Rx Only. For safe and proper use please refer to full device Instructions for Use for Contraindications, Warnings, and Precautions.
Forward-Looking Statements
This release includes forward-looking statements concerning potential benefits associated with Hemopatch Sealing Hemostat. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Hemopatch Sealing Hemostat and Baxter are registered trademarks of Baxter International Inc.
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1 Lombardo C, Lopez-Ben S, Boggi U, Gutowski P, Hrbac T, Krska L, Marquez-Rivas J, Russello D, York E, Zacharias M. Hemopatch® is effective and safe to use: real-world data from a prospective European registry study. Updates Surg. 2022 Oct;74(5):1521-1531. doi: 10.1007/s13304-022-01353-y. Epub 2022 Aug 20. PMID: 35986865; PMCID: PMC9481486. |
2 Prof. Dr. med. Selman Uranüs, is one of the speakers at the symposium and has signed a speaker agreement |
3 IFU Hemopatch Sealing Hemostat 09/2024 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250409022593/en/
Media Contact
Peggy Dekker-Kühnen, (224) 948-5353
media@baxter.com
Investor Contact
Clare Trachtman, (224) 948-3020
Source: Baxter International Inc.
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