Paragon 28 Launches the Phantom® Fibula Nail System for Less Invasive Fracture Repair
Paragon 28 (NYSE: FNA) has launched the Phantom® Fibula Nail System, offering surgeons a less invasive option for treating ankle fractures. This system has shown fewer soft tissue complications, implant removals, and fracture nonunion compared to traditional plate and screw fixation. The system includes innovative features such as:
- Instrumentation for anatomic reduction and proper implant placement
- An Entry K-Wire Guide for correct starting point identification
- A Curved Reamer Guide for proper implant angle
- Screws that thread into the nail
- An expandable proximal locking mechanism
- Compatibility with Paragon 28's syndesmotic implant options
The Phantom® Fibula Nail System is delivered in one surgical tray with sterile packed implants, simplifying surgical workflow and inventory management. It joins Paragon 28's extensive foot and ankle fracture portfolio.
Paragon 28 (NYSE: FNA) ha lanciato il Phantom® Fibula Nail System, offrendo ai chirurghi un'opzione meno invasiva per il trattamento delle fratture alla caviglia. Questo sistema ha dimostrato una minore incidenza di complicazioni ai tessuti molli, rimozioni di impianti e non unioni delle fratture rispetto alla tradizionale fissazione con placche e viti. Il sistema include caratteristiche innovative come:
- Strumentazione per una riduzione anatomica e una corretta posizionamento dell'impianto
- Una guida per K-Wire di ingresso per identificare il corretto punto di partenza
- Una guida per reamer curvo per il corretto angolo dell'impianto
- Viti che si avvitano nella spirale
- Un meccanismo di bloccaggio prossimale espandibile
- Compatibilità con le opzioni di impianto sindesmotico di Paragon 28
Il Phantom® Fibula Nail System viene fornito in un vassoio chirurgico con impianti confezionati in modo sterile, semplificando il flusso di lavoro chirurgico e la gestione dell'inventario. Si unisce al vasto portafoglio di fratture del piede e della caviglia di Paragon 28.
Paragon 28 (NYSE: FNA) ha lanzado el Phantom® Fibula Nail System, ofreciendo a los cirujanos una opción menos invasiva para tratar las fracturas de tobillo. Este sistema ha mostrado menos complicaciones en los tejidos blandos, retiros de implantes y no unión de fracturas en comparación con la fijación tradicional de placas y tornillos. El sistema incluye características innovadoras como:
- Instrumentación para reducción anatómica y correcta colocación del implante
- Una guía de K-Wire de entrada para la identificación del punto de inicio correcto
- Una guía de reamer curvado para el ángulo adecuado del implante
- Tornillos que se enroscan en el clavo
- Un mecanismo de bloqueo proximal expandible
- Compatibilidad con las opciones de implantes sindesmoticos de Paragon 28
El Phantom® Fibula Nail System se entrega en una bandeja quirúrgica con implantes empaquetados de forma estéril, lo que simplifica el flujo de trabajo quirúrgico y la gestión de inventario. Se une al extenso portafolio de fracturas del pie y tobillo de Paragon 28.
Paragon 28 (NYSE: FNA)는 외과 의사에게 발목 골절 치료를 위한 덜 침습적인 옵션을 제공하는 Phantom® Fibula Nail System을 출시했습니다. 이 시스템은 전통적인 플레이트 및 나사 고정 방식에 비해 부드러운 조직 합병증, 임플란트 제거 및 골절 비유니온이 더 적은 것으로 나타났습니다. 이 시스템은 다음과 같은 혁신적인 기능을 포함합니다:
- 해부학적 재설정 및 올바른 임플란트 배치를 위한 기구
- 올바른 시작 점 식별을 위한 K-Wire 가이드
- 올바른 임플란트 각도를 위한 곡선 리머 가이드
- 못에 나사로 연결되는 나사
- 팽창 가능한 근위 잠금 메커니즘
- Paragon 28의 섬유 결합 임플란트 옵션과의 호환성
Phantom® Fibula Nail System은 멸균된 임플란트가 포장된 하나의 수술작업대에서 제공되어 수술 작업 흐름 및 재고 관리를 간소화합니다. Paragon 28의 광범위한 발 및 발목 골절 포트폴리오에 추가됩니다.
Paragon 28 (NYSE: FNA) a lancé le Phantom® Fibula Nail System, offrant aux chirurgiens une option moins invasive pour traiter les fractures de la cheville. Ce système a démontré moins de complications des tissus mous, de retrait d'implants et de non-union des fractures par rapport à la fixation traditionnelle par plaques et vis. Le système comprend des caractéristiques innovantes telles que :
- Instrumentation pour réduction anatomique et placement correct de l'implant
- Un guide K-Wire d'entrée pour l'identification du point de départ correct
- Un guide fraisant courbé pour l'angle approprié de l'implant
- Des vis qui se vissent dans le clou
- Un mécanisme de verrouillage proximal expansible
- Compatibilité avec les options d'implants syndesmotique de Paragon 28
Le Phantom® Fibula Nail System est livré dans un plateau chirurgical avec des implants emballés de manière stérile, simplifiant ainsi le flux de travail chirurgical et la gestion des stocks. Il rejoint le vaste portefeuille de fractures du pied et de la cheville de Paragon 28.
Paragon 28 (NYSE: FNA) hat das Phantom® Fibula Nail System auf den Markt gebracht, das Chirurgen eine weniger invasive Option zur Behandlung von Sprunggelenksfrakturen bietet. Dieses System hat wENIGER Weichgewebekomplikationen, Implantatentfernungen und Frakturen ohne Heilung im Vergleich zur traditionellen Platten- und Schraubenfixierung gezeigt. Das System umfasst innovative Funktionen wie:
- Instrumentierung für anatomische Reduktion und richtige Implantatplatzierung
- Eine Einstiegs-K-Wire-Leitlinie zur korrekten Identifizierung des Startpunkts
- Eine gewinkelte Reamer-Leitlinie für den richtigen Implantatwinkel
- Schrauben, die in den Nagel eingeschraubt werden
- Ein erweiterbarer proximaler Verriegelungsmechanismus
- Kompatibilität mit den syndesmotic Implantatoptionen von Paragon 28
Das Phantom® Fibula Nail System wird in einem chirurgischen Tablett mit steril verpackten Implantaten geliefert, was den chirurgischen Arbeitsablauf und das Bestandsmanagement vereinfacht. Es ergänzt das umfangreiche Portfolio von Frakturen des Fußes und Sprunggelenks von Paragon 28.
- Launch of a new product (Phantom® Fibula Nail System) expanding the company's foot and ankle fracture portfolio
- The new system shows fewer complications and better outcomes compared to traditional methods
- Innovative features that improve surgical precision and stability
- Compatibility with other Paragon 28 products for syndesmotic fixation
- Simplified surgical workflow and inventory management
- None.
Insights
The launch of the Phantom® Fibula Nail System represents a significant advancement in ankle fracture treatment. This less invasive option offers several key advantages over traditional plate and screw fixation:
- Reduced soft tissue complications
- Fewer implant removals
- Lower fracture nonunion rates
The system's innovative features, such as the Entry K-Wire Guide and Curved Reamer Guide, enhance surgical precision and ease of use. The threaded screws and expandable proximal locking mechanism provide improved stability, which is important for fracture healing.
Importantly, the system's compatibility with Paragon 28's syndesmotic implant options, including the new R3FLEX™ and R3ACT™ Stabilization Systems, offers a comprehensive solution for complex ankle fractures. This integration could potentially lead to better patient outcomes and reduced recovery times.
For Paragon 28, this launch strengthens their position in the foot and ankle fracture market, complementing their existing portfolio and potentially driving future revenue growth.
The launch of the Phantom® Fibula Nail System is a positive development for Paragon 28 (NYSE: FNA). This innovative product addresses a significant market need and has the potential to drive revenue growth in the coming quarters. Key financial implications include:
- Expanded market share in the ankle fracture treatment segment
- Potential for higher profit margins due to the system's advanced features
- Cross-selling opportunities with existing syndesmotic implant options
- Reduced inventory costs for hospitals due to the single-tray design
With a market cap of
However, investors should monitor adoption rates among surgeons and any potential regulatory challenges. The success of this product could significantly impact the company's financial performance in the medium to long term.
Figure 1: Phantom® Fibula Nail implanted in the fibula for fracture stabilization with syndesmotic repair using the R3FLEX™ Stabilization System (Photo: Business Wire)
The Phantom® Fibula Nail System provides surgeons with instrumentation to help facilitate anatomic reduction and proper implant placement. This includes an Entry K-Wire Guide to aid identification of the correct starting point for the nail and a Curved Reamer Guide to help direct the surgeon to the correct angle of the fibula at which to implant the nail. The system instrumentation also allows the surgeon to pull traction on the fibula to reduce the fracture intraoperatively. Innovative implant features such as screws that thread into the nail and an expandable proximal locking mechanism allow for optimal stability in the fibula. Additionally, syndesmotic fixation can be achieved through the nail with one of the many novel Paragon 28 syndesmotic implant options, including the Company’s recently launched R3FLEX™ and R3ACT™ Stabilization Systems.
Surgeon Designer Dr. Charles Moon comments, “The Phantom Fibula Nail System offers surgeons an excellent surgical option for treating a fractured fibula with several next-generation features that truly set the system apart. The novel instruments designed to provide a reproducible starting point and the ability to pull traction for fracture alignment add measurable value to surgeons and lead to better outcomes for patients. The threaded distal screws and user-friendly proximal locking option help optimize stability, which is vital to fracture healing.”
“I’m thrilled for patients and surgeons alike to experience the impact of the Phantom Fibula Nail System,” says Albert DaCosta, CEO of Paragon 28. “We’ve developed a special product here, with a design that sets it apart from current offerings for fibula fractures. The Phantom® Fibula Nail System gives surgeons precision and control for fractures that are often difficult to stabilize, which we expect will result in better, more reproducible patient outcomes.”
The Phantom® Fibula Nail System is delivered in one surgical tray along with a small set of sterile packed implants designed to simplify surgical workflow and inventory management.
The Phantom® Fibula Nail System adds to Paragon 28’s innovative foot and ankle fracture portfolio which includes the Gorilla® Ankle Fracture System, Gorilla® Pilon Plating System, Baby Gorilla® Plating System, Gorilla® Calcaneus Fracture Plating System, Gorilla® LisFranc Plating System, Monkey Bars™ External Fixation System, and PRECISION® Jones Fracture Screw System.
About Paragon 28, Inc.
Based in
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Paragon 28’s business in general, see Paragon 28’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023 and its Quarterly Reports on Form 10-Q, as updated periodically with its other lings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Disclaimer
Dr. Moon may report consulting and royalty fees from Paragon 28 in connection with the provision of product development services to Paragon 28.
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.
References
- Tas, David B., et al. "Intramedullary fixation versus plate fixation of distal fibular fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies." The Journal of Foot and Ankle Surgery 58.1 (2019): 119-126.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241016226468/en/
Investor Contact
Matthew Brinckman
Senior Vice President, Strategy and Investor Relations
Phone: (720) 912-1332
Source: Paragon 28, Inc.
FAQ
What is the Phantom® Fibula Nail System launched by Paragon 28 (FNA)?
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