Surmodics Receives FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter
Surmodics (Nasdaq: SRDX) has received FDA 510(k) clearance for its Pounce™ XL Thrombectomy System, expanding its Pounce Thrombectomy Platform to treat peripheral arteries up to 10 mm in diameter. This new system is designed for non-surgical removal of thrombi and emboli in vessels 5.5–10 mm, including iliac and femoral arteries. The Pounce Thrombectomy Platform already includes systems for 2–6 mm arteries. The Pounce XL aims to address critically ischemic lower extremity vessels, providing a rapid solution for various clot morphologies without thrombolytics. market release is expected in early 2025, followed by full commercialization.
Surmodics (Nasdaq: SRDX) ha ricevuto l'approvazione della FDA 510(k) per il suo Pounce™ XL Thrombectomy System, ampliando la sua Pounce Thrombectomy Platform per trattare le arterie periferiche fino a 10 mm di diametro. Questo nuovo sistema è progettato per la rimozione non chirurgica di trombi ed emboli in vasi da 5,5 a 10 mm, comprese le arterie iliache e femorali. La Pounce Thrombectomy Platform include già sistemi per arterie da 2 a 6 mm. Il Pounce XL mira a trattare i vasi degli arti inferiori criticamente ischemici, fornendo una soluzione rapida per varie morfologie di coaguli senza l'uso di trombolitici. Il lancio sul mercato è previsto per all'inizio del 2025, seguito dalla commercializzazione completa.
Surmodics (Nasdaq: SRDX) ha recibido la aprobación 510(k) de la FDA para su Pounce™ XL Thrombectomy System, expandiendo su plataforma Pounce Thrombectomy para tratar arterias periféricas de hasta 10 mm de diámetro. Este nuevo sistema está diseñado para la eliminación no quirúrgica de trombos y émbolos en vasos de 5.5 a 10 mm, incluidas las arterias ilíacas y femorales. La plataforma Pounce Thrombectomy ya incluye sistemas para arterias de 2 a 6 mm. El Pounce XL tiene como objetivo abordar los vasos de las extremidades inferiores críticamente isquémicos, proporcionando una solución rápida para varias morfologías de coágulos sin trombolíticos. Se espera que el lanzamiento al mercado ocurra a principios de 2025, seguido de la comercialización completa.
Surmodics (나스닥: SRDX)는 Pounce™ XL Thrombectomy System에 대한 FDA 510(k) 승인을 받았으며, 최대 10mm 직경의 말초 동맥을 치료하기 위해 Pounce Thrombectomy Platform을 확장하고 있습니다. 이 새로운 시스템은 5.5~10mm의 혈관에서 혈전 및 색전의 비수술적 제거를 위해 설계되었습니다. 여기에는 장골 및 대퇴 동맥이 포함됩니다. Pounce Thrombectomy Platform은 이미 2~6mm 동맥을 위한 시스템을 포함하고 있습니다. Pounce XL은 심각하게 허혈적인 하체 혈관을 다루기 위해 설계되었으며, 여러 가지 응고 형태에 대한 빠른 솔루션을 제공합니다. 시장 출시 예정일은 2025년 초이며, 이후 완전 상용화가 이루어집니다.
Surmodics (Nasdaq: SRDX) a reçu l'approbation 510(k) de la FDA pour son Pounce™ XL Thrombectomy System, élargissant ainsi sa Pounce Thrombectomy Platform pour traiter les artères périphériques jusqu'à 10 mm de diamètre. Ce nouveau système est conçu pour l'élimination non chirurgicale des thrombus et des emboles dans les vaisseaux de 5,5 à 10 mm, y compris les artères iliaques et fémorales. La Pounce Thrombectomy Platform comprend déjà des systèmes pour des artères de 2 à 6 mm. Le Pounce XL vise à traiter les vaisseaux des membres inférieurs en état critique d'ischémie, offrant une solution rapide pour diverses morphologies de caillots sans thrombolytique. La sortie sur le marché est prévue pour début 2025, suivie d'une commercialisation complète.
Surmodics (Nasdaq: SRDX) hat die FDA 510(k)-Zulassung für sein Pounce™ XL Thrombectomy System erhalten, und erweitert damit seine Pounce Thrombectomy Platform zur Behandlung peripherer Arterien mit einem Durchmesser von bis zu 10 mm. Dieses neue System ist für die nicht-chirurgische Entfernung von Thromben und Emboli in Gefäßen von 5,5 bis 10 mm konzipiert, einschließlich der iliakalen und femoralen Arterien. Die Pounce Thrombectomy Platform umfasst bereits Systeme für Arterien mit 2 bis 6 mm. Das Pounce XL zielt darauf ab, kritisch ischämische Gefäße der unteren Extremitäten zu behandeln, und bietet eine schnelle Lösung für verschiedene Blutgerinnsel-Morphologien ohne Thrombolytika. Der Markteintritt wird Anfang 2025 erwartet, gefolgt von einer vollständigen Kommerzialisierung.
- FDA 510(k) clearance for Pounce XL Thrombectomy System.
- Expands addressable market to peripheral arteries up to 10 mm.
- Potential to reduce follow-up procedures and ICU admissions.
- market release in early 2025, followed by commercialization.
- None.
Insights
The FDA 510(k) clearance for Surmodics' Pounce™ XL Thrombectomy System is a significant development in the peripheral vascular device market. This expansion of the Pounce platform to treat larger arteries (5.5-10 mm) complements their existing offerings for smaller vessels, creating a comprehensive solution for thrombus removal across various vessel sizes (2-10 mm).
The system's ability to remove both acute and chronic clots without thrombolytics is a key differentiator. This feature potentially reduces the need for ICU admissions and follow-up procedures, which could lead to cost savings for healthcare providers and improved patient outcomes. The platform's versatility in addressing different clot morphologies also positions it well in the competitive landscape.
From an investor perspective, this clearance expands Surmodics' addressable market significantly. The planned market release in H1 2025 suggests a cautious but strategic approach to commercialization, allowing for real-world validation before full-scale launch. This could positively impact the company's revenue streams in the medium to long term, especially if adoption rates are strong among vascular specialists.
This FDA clearance represents a strategic market expansion for Surmodics in the thrombectomy device sector. The global peripheral vascular devices market, valued at
The Pounce XL system addresses a critical clinical need in treating larger peripheral arteries, potentially reducing procedure times and improving outcomes. This could drive adoption among healthcare providers looking for efficient, cost-effective solutions. The platform's ability to handle various clot types without thrombolytics also aligns with the trend towards minimizing ICU stays and reducing healthcare costs.
Investors should note that while the immediate financial impact may be due to the planned 2025 release, this clearance strengthens Surmodics' long-term competitive position. The company's focus on innovation in critical care areas could lead to increased market share and potential partnerships with larger medical device companies, enhancing its value proposition in the medical technology sector.
The Pounce™ Thrombectomy Platform can now be used to remove clot from peripheral arteries as small as 2mm up to as large as 10 mm in diameter, broadening the platform's clinical utility and significantly expanding its addressable market
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within this range. The Pounce XL Thrombectomy System dramatically increases the size range of the Pounce Thrombectomy Platform, which also includes the Pounce Thrombectomy System, indicated for 3.5–6 mm peripheral arteries, and the Pounce LP (Low Profile) Thrombectomy System, indicated for 2–4 mm peripheral arteries. The Pounce Thrombectomy System and Pounce LP Thrombectomy System were introduced in 2021 and 2024, respectively.
“Securing FDA clearance for the Pounce XL Thrombectomy System is a major step forward in Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, notably critically ischemic lower extremity vessels,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The Pounce Thrombectomy Platform has already demonstrated its performance as a rapid, efficient solution for the removal of both acute and chronic thrombi and emboli in peripheral arteries without the use of thrombolytics. The addition of the Pounce XL Thrombectomy System to our Pounce Thrombectomy Platform demonstrates our commitment to setting the pace and direction of innovation in this critical space.”
Mr. Maharaj added, “Critically ischemic peripheral arteries often have older, organized clots that resist catheter-directed thrombolysis and aspiration thrombectomy. The Pounce Thrombectomy Platform allows physicians to rapidly restore blood flow regardless of clot morphology, which has the potential to reduce the need for follow-up procedures and additional thrombolytic therapy requiring ICU admission.”
Surmodics expects to initiate limited market release for the Pounce XL Thrombectomy System in the first half of 2025, with commercialization planned following the completion of the limited market release.
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy System, Pounce LP Thrombectomy System, and Pounce XL Thrombectomy System are fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. Described as “grab-and-go” solutions, Pounce Thrombectomy Platform devices are both readily deployable and simple to use. The systems are 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 Acute Limb Ischemia (ALI)
ALI is characterized by a sudden decrease in arterial perfusion to the limb, with a potential threat to limb survival, requiring urgent evaluation and management. Common causes include embolization due to cardiac dysrhythmia or thrombus from pre-existing peripheral artery disease.1 ALI is associated with 30-day amputation and mortality rates as high as
- Björck M, Earnshaw J, Acosta S, et al. European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb Ischaemia. Eur J Vasc Endovasc Surg. 2020;59(2):173e218.
- Gupta R, Siada SS, Bronsert M, Al-Musawi MH, Nehler MR, Jeniann AY. High Rates of Recurrent Revascularization in Acute Limb Ischemia–A National Surgical Quality Improvement Program Study. Ann Vasc Surg. 2022;87:334-342.
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 Pounce XL Thrombectomy System significantly expanding its addressable market for the product platform, Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, Surmodics’ commitment to setting the pace and direction of innovation in mechanical thrombectomy solutions in peripheral arteries, expectations regarding the initiation of the limited market release and commercialization of the Pounce XL Thrombectomy System, 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 willingness of Premier members to adopt use of the Surmodics thrombectomy products, and 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, 2023, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241001035799/en/
Surmodics Investor Inquiries:
Jack Powell, Investor Relations
ir@surmodics.com
Surmodics Public Relations Inquiries:
pr@surmodics.com
Source: Surmodics, Inc.
FAQ
What is the Pounce™ XL Thrombectomy System?
When did Surmodics receive FDA clearance for the Pounce™ XL Thrombectomy System?
What arteries can the Pounce™ XL Thrombectomy System treat?
When will the Pounce™ XL Thrombectomy System be commercially available?
