AtriCure Receives CE-Mark for the EnCompass® Clamp
AtriCure, Inc. (Nasdaq: ATRC) has received CE-Mark approval to sell the EnCompass® Clamp in European Union countries. This regulatory approval marks a significant expansion of AtriCure's product line internationally. The EnCompass Clamp, which received FDA 510(K) clearance and was launched in the United States in 2022, provides a simpler and faster approach to ablating the heart in open-chest procedures.
Key features of the EnCompass Clamp include:
- Ability to perform comprehensive epicardial ablation of the left atrium in minutes
- Parallel closure, uniform pressure, and custom power using Synergy radiofrequency (RF)
- Magnetic guide for easier placement and more efficient procedures
- Design that fits cardiac anatomy, supporting surgical ablation in procedures like CABG and AVR
AtriCure estimates approximately 400,000 cardiac surgeries occur annually in the European Union, representing a significant market opportunity for the EnCompass Clamp.
AtriCure, Inc. (Nasdaq: ATRC) ha ricevuto l'approvazione CE-Mark per vendere il Clamp EnCompass® nei paesi dell'Unione Europea. Questa approvazione regolamentare segna una significativa espansione della linea di prodotti di AtriCure a livello internazionale. Il Clamp EnCompass, che ha ricevuto l'autorizzazione FDA 510(K) ed è stato lanciato negli Stati Uniti nel 2022, offre un approccio più semplice e veloce per ablare il cuore durante le procedure a torace aperto.
Le caratteristiche principali del Clamp EnCompass includono:
- Capacità di eseguire ablazione epicardica completa dell'atrio sinistro in pochi minuti
- Chiusura parallela, pressione uniforme e potenza personalizzata utilizzando la radiofrequenza (RF) Synergy
- Guida magnetica per un posizionamento più facile e procedure più efficienti
- Design che si adatta all'anatomia cardiaca, supportando l'ablazione chirurgica in procedure come CABG e AVR
AtriCure stima che circa 400.000 interventi cardiaci si svolgano ogni anno nell'Unione Europea, rappresentando un'opportunità di mercato significativa per il Clamp EnCompass.
AtriCure, Inc. (Nasdaq: ATRC) ha recibido la aprobación CE-Mark para vender el Clamp EnCompass® en los países de la Unión Europea. Esta aprobación regulatoria marca una expansión significativa de la línea de productos de AtriCure a nivel internacional. El Clamp EnCompass, que recibió la autorización FDA 510(K) y fue lanzado en Estados Unidos en 2022, proporciona un enfoque más simple y rápido para ablaciones cardíacas en procedimientos de tórax abierto.
Las características clave del Clamp EnCompass incluyen:
- Capacidad para realizar ablación epicárdica completa de la aurícula izquierda en minutos
- Cierre paralelo, presión uniforme y potencia personalizada utilizando radiofrecuencia (RF) Synergy
- Guía magnética para una colocación más fácil y procedimientos más eficientes
- Diseño que se adapta a la anatomía cardiaca, apoyando la ablación quirúrgica en procedimientos como CABG y AVR
AtriCure estima que aproximadamente 400,000 cirugías cardíacas ocurren anualmente en la Unión Europea, lo que representa una oportunidad de mercado significativa para el Clamp EnCompass.
AtriCure, Inc. (Nasdaq: ATRC)는 유럽연합 국가에서 EnCompass® 클램프를 판매하기 위한 CE 마크 승인을 받았습니다. 이 규제 승인은 AtriCure의 제품 라인이 국제적으로 크게 확장되었다는 것을 의미합니다. 2022년 미국에 출시된 EnCompass 클램프는 FDA 510(K) 승인을 받았으며, 개흉 수술에서 심장 절제의 더 쉽고 빠른 접근 방식을 제공합니다.
EnCompass 클램프의 주요 특징은 다음과 같습니다:
- 몇 분 안에 좌심방의 종합적인 심장 절제 수행 가능
- 병행 폐쇄, 균일한 압력 및 Synergy RF(무선 주파수)를 활용한 맞춤형 전력
- 더 쉬운 배치를 위한 자기 가이드 및 더 효율적인 절차
- 심장 해부학에 적합한 설계로 CABG 및 AVR과 같은 수술적 절제를 지원
AtriCure는 유럽연합에서 매년 약 400,000건의 심장 수술이 발생한다고 추정하며, 이는 EnCompass 클램프에 대한 중요한 시장 기회를 나타냅니다.
AtriCure, Inc. (Nasdaq: ATRC) a reçu l'approbation CE-Mark pour vendre le Clamp EnCompass® dans les pays de l'Union Européenne. Cette approbation réglementaire marque une expansion significative de la ligne de produits d'AtriCure à l'international. Le Clamp EnCompass, qui a reçu l'autorisation FDA 510(K) et a été lancé aux États-Unis en 2022, offre une approche plus simple et plus rapide pour l'ablation du cœur lors des interventions à cœur ouvert.
Les principales caractéristiques du Clamp EnCompass incluent :
- Capacité d'effectuer une ablation épicardique complète de l'oreillette gauche en quelques minutes
- Fermeture parallèle, pression uniforme et puissance personnalisée utilisant la radiofréquence (RF) Synergy
- Guide magnétique pour un placement plus facile et des procédures plus efficaces
- Design qui s'adapte à l'anatomie cardiaque, soutenant l'ablation chirurgicale lors de procédures telles que CABG et AVR
AtriCure estime qu'environ 400 000 interventions cardiaques ont lieu chaque année dans l'Union Européenne, représentant une opportunité de marché significative pour le Clamp EnCompass.
AtriCure, Inc. (Nasdaq: ATRC) hat die CE-Kennzeichnung erhalten, um den EnCompass® Clamp in den Ländern der Europäischen Union zu verkaufen. Diese regulatorische Genehmigung markiert eine bedeutende Expansion von AtriCures Produktlinie auf internationaler Ebene. Der EnCompass Clamp, der 2022 in den USA mit der FDA 510(K) Genehmigung eingeführt wurde, bietet einen einfacheren und schnelleren Ansatz zur Ablation des Herzens bei offenen Eingriffen.
Zu den wichtigsten Funktionen des EnCompass Clamps gehören:
- Fähigkeit, innerhalb von Minuten eine umfassende epicardiale Ablation des linken Vorhofs durchzuführen
- Parallele Schließung, gleichmäßiger Druck und maßgeschneiderte Energie mit Synergy-Radiofrequenz (RF)
- Magnetische Führung für einfachere Platzierung und effizientere Verfahren
- Design, das sich an die Herz-Anatomie anpasst und chirurgische Ablationen in Verfahren wie CABG und AVR unterstützt
AtriCure schätzt, dass jährlich etwa 400.000 Herzoperationen in der Europäischen Union durchgeführt werden, was eine bedeutende Marktchance für den EnCompass Clamp darstellt.
- Received CE-Mark approval for the EnCompass® Clamp in European Union countries
- Expands AtriCure's product line internationally
- EnCompass Clamp provides a simpler and faster approach to heart ablation in open-chest procedures
- Potential market of approximately 400,000 annual cardiac surgeries in the European Union
- None.
Insights
The CE-Mark approval for AtriCure's EnCompass® Clamp is a significant development for the company's international growth strategy. This device, which provides a faster and simpler approach to cardiac ablation during open-chest procedures, has already shown positive impact in the U.S. market since its FDA clearance in 2022.
The EnCompass Clamp's key features, including parallel closure, uniform pressure and custom power using Synergy radiofrequency (RF), along with its magnetic guide for easier placement, address important surgical needs. Its design to fit cardiac anatomy is particularly noteworthy, as it supports ablation in procedures like CABG and AVR where the atrium typically remains closed.
With an estimated 400,000 annual cardiac surgeries in the EU, this approval opens a substantial market opportunity for AtriCure. The device's ability to perform comprehensive epicardial ablation of the left atrium in just minutes could potentially increase adoption rates among European surgeons, driving sales growth in this region.
The CE-Mark approval for the EnCompass® Clamp is a positive catalyst for AtriCure's financial outlook. This expansion into the European market significantly broadens the company's addressable market, potentially driving revenue growth in the international segment.
While specific revenue projections aren't provided, the large market of 400,000 annual cardiac surgeries in the EU presents a substantial opportunity. If AtriCure can capture even a small percentage of this market, it could materially impact the company's top line.
Investors should monitor AtriCure's upcoming financial reports for indications of increased international sales and any guidance updates reflecting this new market entry. The success of the EnCompass Clamp in the U.S. over the past two years suggests potential for similar adoption in Europe, which could positively influence the company's valuation and stock performance in the medium to long term.
Approval provides new catalyst for AtriCure’s international growth
“Launching our EnCompass Clamp in
The EnCompass Clamp provides a simpler and faster approach to ablating the heart in open-chest procedures, allowing physicians to perform a comprehensive epicardial ablation of the left atrium in just a few minutes. The EnCompass Clamp includes the features of AtriCure’s existing Synergy™ Clamp family, such as parallel closure, uniform pressure, and custom power using Synergy radiofrequency (RF). The EnCompass Clamp also allows for easier placement using a magnetic guide, which enables more efficient procedures by minimizing tissue dissection. Further, the EnCompass Clamp is designed to fit cardiac anatomy, supporting surgical ablation in procedures where the atrium would normally not be opened such as CABG and AVR. AtriCure estimates approximately 400,000 cardiac surgeries occur annually in the European Union.
Forward-Looking Statements
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law.
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on X (formerly Twitter) @AtriCure.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241001409853/en/
Angie Wirick
Investor Relations
Chief Financial Officer
(513) 755-5334
awirick@atricure.com
Valerie Storch-Willhaus
Media Relations
Vice President, Corporate Marketing & Communications
(612) 605-3311
vstorch-willhaus@atricure.com
Source: AtriCure, Inc.
FAQ
What is the EnCompass® Clamp by AtriCure (ATRC) and what approval did it receive?
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When did AtriCure (ATRC) launch the EnCompass® Clamp in the United States?
