BD Launches Industry-First Bioabsorbable Mesh Designed for Umbilical Hernia Repair
BD (NYSE: BDX) has received FDA 510(k) clearance and launched the Phasix™ ST Umbilical Hernia Patch, marking a significant innovation in hernia repair as the first fully absorbable hernia patch specifically designed for umbilical hernias. The patch is made from Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, combined with a Sepra® Technology hydrogel barrier.
The product maintains the same surgical technique as traditional permanent mesh patches, featuring a pocket and strap design for easy placement. It builds on the success of the Ventralex™ ST Hernia Patch family, which has over two million implants globally. Survey data shows 60% of patients prefer non-permanent mesh options, with 70% of surgeons willing to accommodate these preferences.
The Phasix™ family of products has demonstrated success with over 385,000 implants globally, supported by more than 85 clinical publications studying over 4,000 patients. The new patch is available in three sizes to accommodate various umbilical soft tissue defects.
BD (NYSE: BDX) ha ottenuto l'autorizzazione FDA 510(k) e ha lanciato il Phasix™ ST Umbilical Hernia Patch, rappresentando un'innovazione significativa nella riparazione delle ernie come la prima patch completamente riassorbibile specificamente progettata per le ernie ombelicali. La patch è realizzata in Poli-4-idrossibutirrato (P4HB), un materiale di origine biologica, combinato con una barriera idrogel Sepra® Technology.
Il prodotto mantiene la stessa tecnica chirurgica delle tradizionali mesh permanenti, con un design a tasca e cinghia per un posizionamento semplice. Si basa sul successo della famiglia Ventralex™ ST Hernia Patch, con oltre due milioni di impianti a livello globale. I dati dei sondaggi indicano che il 60% dei pazienti preferisce opzioni di mesh non permanenti, e il 70% dei chirurghi è disposto a soddisfare queste preferenze.
La famiglia di prodotti Phasix™ ha dimostrato successo con oltre 385.000 impianti nel mondo, supportati da più di 85 pubblicazioni cliniche che hanno coinvolto oltre 4.000 pazienti. La nuova patch è disponibile in tre dimensioni per adattarsi a diversi difetti dei tessuti molli ombelicali.
BD (NYSE: BDX) ha recibido la autorización FDA 510(k) y ha lanzado el Phasix™ ST Umbilical Hernia Patch, marcando una innovación significativa en la reparación de hernias como el primer parche completamente absorbible diseñado específicamente para hernias umbilicales. El parche está hecho de Poli-4-hidroxibutirato (P4HB), un material de origen biológico, combinado con una barrera de hidrogel Sepra® Technology.
El producto mantiene la misma técnica quirúrgica que los parches de malla permanentes tradicionales, con un diseño de bolsillo y correa para una colocación sencilla. Se basa en el éxito de la familia Ventralex™ ST Hernia Patch, que cuenta con más de dos millones de implantes a nivel mundial. Los datos de encuestas muestran que el 60% de los pacientes prefieren opciones de malla no permanentes y el 70% de los cirujanos están dispuestos a adaptarse a estas preferencias.
La familia de productos Phasix™ ha demostrado éxito con más de 385,000 implantes globalmente, respaldada por más de 85 publicaciones clínicas que estudiaron a más de 4,000 pacientes. El nuevo parche está disponible en tres tamaños para adaptarse a diversos defectos de tejidos blandos umbilicales.
BD (NYSE: BDX)는 FDA 510(k) 승인을 받고 Phasix™ ST 제대 탈장 패치를 출시하여, 제대 탈장에 특화된 최초의 완전 흡수성 탈장 패치로서 탈장 수술 분야에 중요한 혁신을 이루었습니다. 이 패치는 생물 유래 소재인 폴리-4-하이드록시부티레이트(P4HB)와 Sepra® 기술의 하이드로겔 장벽으로 구성되어 있습니다.
제품은 기존의 영구 메쉬 패치와 동일한 수술 기법을 유지하며, 간편한 삽입을 위한 포켓과 스트랩 디자인을 특징으로 합니다. 전 세계적으로 200만 건 이상의 이식 사례를 보유한 Ventralex™ ST 탈장 패치 제품군의 성공을 기반으로 합니다. 설문 조사에 따르면 환자의 60%가 비영구 메쉬 옵션을 선호하며, 70%의 외과의가 이러한 선호를 수용할 의향이 있습니다.
Phasix™ 제품군은 전 세계적으로 385,000건 이상의 이식 성공 사례를 보유하고 있으며, 4,000명 이상의 환자를 대상으로 한 85건 이상의 임상 논문으로 뒷받침되고 있습니다. 새 패치는 다양한 제대 연조직 결손에 맞게 세 가지 크기로 제공됩니다.
BD (NYSE : BDX) a obtenu l'autorisation FDA 510(k) et lancé le Phasix™ ST Umbilical Hernia Patch, marquant une avancée majeure dans la réparation des hernies en tant que premier patch entièrement résorbable spécifiquement conçu pour les hernies ombilicales. Le patch est fabriqué en Poly-4-hydroxybutyrate (P4HB), un matériau d'origine biologique, associé à une barrière hydrogel Sepra® Technology.
Le produit conserve la même technique chirurgicale que les mailles permanentes traditionnelles, avec un design poche et sangle pour un positionnement facile. Il s'appuie sur le succès de la famille Ventralex™ ST Hernia Patch, qui compte plus de deux millions d'implants dans le monde. Les enquêtes montrent que 60 % des patients préfèrent des options sans mailles permanentes, et 70 % des chirurgiens sont prêts à répondre à ces préférences.
La famille de produits Phasix™ a démontré son efficacité avec plus de 385 000 implants dans le monde, soutenue par plus de 85 publications cliniques portant sur plus de 4 000 patients. Le nouveau patch est disponible en trois tailles pour s'adapter à divers défauts des tissus mous ombilicaux.
BD (NYSE: BDX) hat die FDA 510(k)-Zulassung erhalten und den Phasix™ ST Umbilical Hernia Patch eingeführt, eine bedeutende Innovation in der Hernienreparatur als erster vollständig resorbierbarer Patch, der speziell für Nabelhernien entwickelt wurde. Der Patch besteht aus Poly-4-hydroxybutyrat (P4HB), einem biologisch gewonnenen Material, kombiniert mit einer Sepra® Technology Hydrogel-Barriere.
Das Produkt verwendet die gleiche chirurgische Technik wie herkömmliche permanente Netzpflaster und verfügt über ein Taschen- und Riemendesign für eine einfache Platzierung. Es baut auf dem Erfolg der Ventralex™ ST Hernia Patch-Familie auf, die weltweit über zwei Millionen Implantate verzeichnet. Umfragedaten zeigen, dass 60 % der Patienten nicht-permanente Netzoptionen bevorzugen, und 70 % der Chirurgen sind bereit, diese Wünsche zu berücksichtigen.
Die Phasix™-Produktfamilie hat mit über 385.000 Implantaten weltweit Erfolge erzielt und wird durch mehr als 85 klinische Publikationen unterstützt, die über 4.000 Patienten untersucht haben. Der neue Patch ist in drei Größen erhältlich, um verschiedene umbilikale Weichteildefekte abzudecken.
- FDA 510(k) clearance received for innovative first-in-class product
- Strong market potential with 60% of patients preferring non-permanent mesh
- Builds on proven success with over 385,000 global implants in Phasix family
- Extensive clinical validation with 85+ publications and 4,000+ patients studied
- None.
Insights
BD's FDA-cleared bioabsorbable umbilical hernia mesh creates first-mover advantage in a growing market segment with strong patient demand.
The FDA 510(k) clearance and launch of BD's Phasix™ ST Umbilical Hernia Patch marks a significant market differentiation as the first and only fully absorbable patch specifically designed for umbilical hernias. This strategic product introduction builds upon BD's established biomaterials platform while addressing a specific unmet clinical need.
Market dynamics strongly favor this innovation, with survey data showing
The product's design brilliantly reduces adoption barriers by allowing surgeons to use the same techniques they currently employ with permanent mesh products. By leveraging the familiar deployment method of their Ventralex™ ST Hernia Patch (which has over 2 million implants globally), BD minimizes the learning curve – a critical factor in new medical device adoption.
This launch strengthens BD's expanding Phasix™ portfolio, which already boasts over 385,000 implants worldwide and substantial clinical validation across 85+ published studies involving 4,000+ patients. The robust clinical foundation provides physicians with confidence in the technology's performance, potentially accelerating uptake.
For BD investors, this represents another example of the company successfully executing on its strategy to expand its advanced biomaterials platform and drive innovation in tissue reconstruction – areas that typically command premium pricing and strong clinical demand.
Revolutionary bioabsorbable umbilical hernia mesh eliminates permanent implant concerns while maintaining familiar surgical technique, addressing significant patient preference.
The Phasix™ ST Umbilical Hernia Patch represents a genuine breakthrough in umbilical hernia repair. The P4HB biologically-derived material combined with Sepra® Technology hydrogel barrier creates a fully absorbable solution that eliminates long-term foreign body presence – a key concern with permanent mesh options.
From a surgical perspective, the ingenious design maintains the pocket-and-strap configuration surgeons are already familiar with from BD's Ventralex™ line. This means immediate adoptability without requiring new surgical techniques or extensive retraining. The availability in three different sizes ensures appropriate coverage across various defect dimensions, optimizing the critical mesh-to-defect overlap ratio essential for successful repairs.
The clinical evidence supporting this technology is substantial, with the broader Phasix™ platform documented across 85+ peer-reviewed publications. This evidence base is crucial for clinical adoption and potential insurance coverage considerations.
Umbilical hernias represent a significant portion of abdominal wall hernia repairs, and until now, surgeons faced a difficult choice between permanent synthetic materials or more complex biological options. This product bridges that gap, offering the handling characteristics of synthetic mesh with the long-term advantage of complete absorption.
Dr. Harrell's enthusiastic endorsement about "waiting and hoping for this product" reflects the pent-up demand for exactly this solution among practitioners. Combined with the statistic that
Phasix™ ST Umbilical Hernia Patch Leverages Same Surgical Technique as Permanent Mesh Procedures
"I've been waiting and hoping for this product to come to market for many years, and I'm thrilled that it's finally here for us to use," said Dr. Robert Harrell, a general surgeon from
Composed of Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, with the added benefits of a proven hydrogel barrier based on Sepra® Technology, Phasix™ ST Umbilical Hernia Patch offers a unique absorbable solution to umbilical hernia repair. It can be deployed using the same technique surgeons use with a traditional permanent mesh patch, while providing material optionality. The pocket and strap design facilitates placement, positioning, and lateral fixation, and is designed to duplicate the form, function, and technique of the Ventralex™ ST Hernia Patch – a product family with more than two million implants globally.
"BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh," said Ron Silverman, chief medical officer for BD. "This marks another milestone in hernia repair innovation and further positions BD as a leader in advanced biomaterial science – driving transformative change in tissue reconstruction."
Recent survey data indicates that
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.
References:
- BD data on file.
- Based on sales data.
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SOURCE BD (Becton, Dickinson and Company)
FAQ
What makes the Phasix ST Umbilical Hernia Patch (BDX) unique in the market?
How many global implants has BD's Phasix Mesh product line achieved?
What percentage of patients prefer non-permanent mesh for hernia repair according to BD's survey?
How many size options are available for the Phasix ST Umbilical Hernia Patch?
