Surmodics Announces Successful Early Clinical Use of Pounce™ XL Thrombectomy System, Suitable for Non-Surgical Removal of Thrombi and Emboli from Iliac and Femoral Arteries
Surmodics (SRDX) announced successful early clinical use of its Pounce™ XL Thrombectomy System, which received FDA 510(k) clearance in September 2024. The system is designed for non-surgical removal of thrombi and emboli from peripheral arteries ranging from 5.5-10 mm in diameter, typical of iliac and femoral arteries.
The Pounce XL complements existing Pounce and Pounce LP systems, which target smaller vessels (3.5-6 mm and 2-4 mm respectively). Dr. Walter Rizzoni at UPMC Hamot successfully used the device to restore blood flow in an 8mm thrombosed stent graft. The system is currently in market release, with full commercial launch planned afterward.
The expanded Pounce Thrombectomy Platform now offers a standalone solution for rapid clot removal throughout the lower extremity without requiring aspiration, thrombolysis, or capital equipment, potentially reducing hospitalization costs and follow-up procedures.
Surmodics (SRDX) ha annunciato l'uso clinico precoce e di successo del suo Pounce™ XL Thrombectomy System, che ha ricevuto l'approvazione FDA 510(k) a settembre 2024. Il sistema è progettato per la rimozione non chirurgica di trombi ed emboli dalle arterie periferiche con diametri compresi tra 5.5 e 10 mm, tipici delle arterie iliache e femorali.
Il Pounce XL si aggiunge ai sistemi Pounce e Pounce LP esistenti, che sono destinati a vasi più piccoli (rispettivamente 3.5-6 mm e 2-4 mm). Il Dr. Walter Rizzoni dell'UPMC Hamot ha utilizzato con successo il dispositivo per ripristinare il flusso sanguigno in un graft stent trombizzato di 8 mm. Il sistema è attualmente in fase di rilascio sul mercato, con il lancio commerciale completo previsto successivamente.
La piattaforma di trombectomia Pounce ampliata offre ora una soluzione autonoma per la rapida rimozione dei coaguli in tutto l'arto inferiore senza richiedere aspirazione, trombolisi o attrezzature costose, riducendo potenzialmente i costi di ospedalizzazione e le procedure di follow-up.
Surmodics (SRDX) anunció el exitoso uso clínico temprano de su Sistema de Trombectomía Pounce™ XL, que recibió la autorización 510(k) de la FDA en septiembre de 2024. El sistema está diseñado para la remoción no quirúrgica de trombos y émbolos de arterias periféricas con diámetros que oscilan entre 5.5 y 10 mm, típicos de las arterias ilíacas y femorales.
El Pounce XL complementa los sistemas existentes Pounce y Pounce LP, que están dirigidos a vasos más pequeños (3.5-6 mm y 2-4 mm, respectivamente). El Dr. Walter Rizzoni en UPMC Hamot utilizó con éxito el dispositivo para restaurar el flujo sanguíneo en un injerto de stent trombosado de 8 mm. El sistema está actualmente en lanzamiento al mercado, con un lanzamiento comercial completo planeado posteriormente.
La plataforma de trombectomía Pounce ampliada ahora ofrece una solución independiente para la rápida eliminación de coágulos en toda la extremidad inferior sin requerir aspiración, trombólisis o equipo costoso, lo que podría reducir los costos de hospitalización y los procedimientos de seguimiento.
Surmodics (SRDX)는 2024년 9월 FDA 510(k) 승인을 받은 Pounce™ XL 혈전제거 시스템의 조기 임상 사용이 성공적으로 이루어졌다고 발표했습니다. 이 시스템은 직경이 5.5-10 mm인 말초 동맥에서 혈전과 색전의 비수술적 제거를 위해 설계되었습니다.
Pounce XL은 각각 3.5-6 mm 및 2-4 mm 크기의 더 작은 혈관을 대상으로 하는 기존 Pounce 및 Pounce LP 시스템을 보완합니다. UPMC Hamot의 Walter Rizzoni 박사는 8mm 혈전이 있는 스텐트 이식편에서 혈류를 복원하기 위해 이 장치를 성공적으로 사용했습니다. 이 시스템은 현재 시장 출시 단계에 있으며, 이후에 완전 상업 출시가 계획되어 있습니다.
확대된 Pounce 혈전제거 플랫폼은 흡입, 혈전 용해 또는 고가 장비 없이 하부 팔다리 전반에 걸쳐 빠른 혈전 제거를 위한 독립형 솔루션을 제공하여 병원 비용 및 후속 절차를 줄일 수 있습니다.
Surmodics (SRDX) a annoncé avec succès l'utilisation clinique précoce de son Système de Thrombectomie Pounce™ XL, qui a reçu l'autorisation 510(k) de la FDA en septembre 2024. Le système est conçu pour le retrait non chirurgical des thrombus et des emboles des artères périphériques ayant un diamètre de 5,5 à 10 mm, typiques des artères iliaques et fémorales.
Le Pounce XL complète les systèmes Pounce et Pounce LP existants, qui ciblent des vaisseaux plus petits (respectivement 3,5-6 mm et 2-4 mm). Le Dr Walter Rizzoni de l'UPMC Hamot a utilisé avec succès le dispositif pour restaurer le flux sanguin dans un greffon de stent thrombosé de 8 mm. Le système est actuellement en phase de lancement sur le marché, avec un lancement commercial complet prévu par la suite.
La plateforme de thrombectomie Pounce élargie offre désormais une solution autonome pour l'élimination rapide des caillots dans l'ensemble des membres inférieurs sans nécessiter d'aspiration, de thrombolyse ou d'équipement coûteux, ce qui pourrait potentiellement réduire les coûts d'hospitalisation et les procédures de suivi.
Surmodics (SRDX) gab bekannt, dass der frühzeitige klinische Einsatz seines Pounce™ XL Thrombektomiesystems, das im September 2024 die FDA 510(k)-Zulassung erhielt, erfolgreich war. Das System wurde für die nicht-chirurgische Entfernung von Thromben und Emboli aus peripheren Arterien mit Durchmessern von 5,5 bis 10 mm, typischerweise in den iliakalen und femoralen Arterien, konzipiert.
Der Pounce XL ergänzt die bestehenden Systeme Pounce und Pounce LP, die auf kleinere Gefäße (jeweils 3,5-6 mm und 2-4 mm) abzielen. Dr. Walter Rizzoni von UPMC Hamot verwendete das Gerät erfolgreich, um den Blutfluss in einem 8 mm thrombierten Stent-Graft wiederherzustellen. Das System ist derzeit für die Markteinführung vorgesehen, mit einer vollständigen kommerziellen Einführung, die danach geplant ist.
Die erweiterte Pounce-Thrombektomie-Plattform bietet nun eine eigenständige Lösung zur schnellen Entfernung von Blutgerinnseln im gesamten unteren Extremitätenbereich, ohne dass Aspiration, Thrombolyse oder teure Geräte erforderlich sind, was potenziell die Krankenhauskosten und Nachbehandlungsverfahren senken kann.
- FDA 510(k) clearance received for Pounce XL Thrombectomy System
- Successful first clinical use demonstrated
- Expands addressable market to larger vessels (5.5-10mm)
- Potential to reduce healthcare costs by eliminating need for additional equipment and procedures
- Product still in market release phase
- Full commercial launch timeline not specified
Insights
The successful clinical deployment of Surmodics' Pounce™ XL Thrombectomy System marks a strategic expansion in the
First, the system's capability to handle 5.5-10mm vessels fills a critical gap in the peripheral vascular intervention space. When combined with the existing Pounce™ portfolio (2-4mm and 3.5-6mm), it creates a comprehensive platform that can address the entire spectrum of peripheral arterial thrombosis cases. This positions Surmodics to capture a larger market share in the competitive thrombectomy space.
Second, the standalone nature of the system - requiring no aspiration, thrombolysis, or capital equipment - represents a compelling value proposition for healthcare facilities. Traditional thrombectomy procedures often require expensive capital equipment and additional disposables, leading to higher procedure costs. The Pounce™ platform's simplified approach could potentially reduce procedure costs by
- Elimination of capital equipment requirements
- Reduced procedural complexity and time
- Lower risk of complications requiring extended hospital stays
- Decreased need for thrombolytic drugs
Third, the successful removal of chronic material during initial clinical use suggests broader applications beyond acute thrombosis, potentially expanding the addressable market. This capability could reduce the need for more invasive surgical interventions in some cases.
The market release strategy allows Surmodics to gather real-world evidence while refining their commercialization approach, potentially leading to stronger market penetration during full commercial launch. This methodical approach, combined with the platform's comprehensive vessel size coverage, positions Surmodics for potential revenue growth in the thrombectomy segment.
With the addition of the Pounce™ XL Thrombectomy System, indicated for use in 5.5–10 mm peripheral arteries, the Pounce™ Thrombectomy Platform can now rapidly remove acute or chronic clot throughout the lower extremity without aspiration, thrombolysis, or capital equipment.
Surmodics Pounce Thrombectomy systems are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL Thrombectomy System is indicated for use in vessels ranging from 5.5–10 mm in diameter, sizes typical of iliac and femoral arteries. The Pounce XL System complements the Pounce and Pounce LP Thrombectomy Systems, which are indicated for 3.5–6 mm and 2–4 mm vessels, respectively.
University of Pittsburg Medical Center (UPMC) Hamot vascular surgeon Dr. Walter Rizzoni successfully used the new Pounce XL Thrombectomy System to restore blood flow in a thrombosed stent graft 8 mm in diameter. This marks Dr. Rizzoni's first case using the innovative device at the
“The Pounce XL Thrombectomy System removed a significant amount of chronic material during our first use,” said Dr. Rizzoni. “In that respect, its performance was right in line with our experience using the Pounce and Pounce LP Systems.”
“We’re excited about the positive feedback we’ve received from early users of the Pounce XL System,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The addition of this larger-profile device to the Pounce Thrombectomy Platform fulfills our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity. With hospitals under growing pressure to reduce costs, we believe the standalone Pounce Thrombectomy Platform may help reduce the need for hospitalizations and follow-up procedures.”
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are indicated for use in peripheral arteries 3.5–6 mm, 2–4 mm, and 5.5–10 mm in diameter, respectively. The Pounce XL Thrombectomy System is currently pending full commercial release.
Described as “grab-and-go” solutions, Pounce Thrombectomy Platform systems are readily deployable and simple to use. Each system is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.
About the PROWL registry
PROWL is an open-label, retrospective, multi-center,
On January 29, 2025, early results from the PROWL registry were presented at the 20th annual Leipzig Interventional Course (LINC) in
About Surmodics, Inc.
Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding the expectation of full commercial launch of the Pounce XL Thrombectomy System following completion of the LMR, our belief that the standalone Pounce Platform may help reduce the need for hospitalizations and follow-up procedures, and Surmodics’ growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
* No patient data for the Pounce XL System was available from the LINC subset analysis.
1. Leung DA, Blitz LR, Nelson T, et al. Rheolytic pharmacomechanical thrombectomy for the management of acute limb ischemia: results from the PEARL registry. J Endovasc Ther. 2015;22(4):546-557.
2. Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584-592.
3. de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thrombo-aspiration in patients with acute lower limb ischaemia: the INDIAN trial. Eur J Vasc Endovasc Surg. 2021;61(5):820-828.
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FAQ
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