Haemonetics Announces CE Mark Certification for the SavvyWire® Pre-Shaped Pressure Guidewire
Haemonetics (NYSE: HAE) has announced CE Mark certification and the first commercial European procedures for its SavvyWire® Pre-Shaped Pressure Guidewire. This innovative device is the world's first 3-in-1 solution for Transcatheter Aortic Valve Implantation (TAVI), offering improved procedural efficiency through predictable wire performance, hemodynamic measurement, and left-ventricular pacing capabilities.
The certification allows Haemonetics to enter EU markets and other regions recognizing CE marking. The first commercial European procedures were performed in France and The Netherlands. The SavvyWire guidewire reduces procedural device exchanges, provides stable aortic valve delivery, and enables continuous cardiac hemodynamic monitoring. It also allows for reliable LV pacing without additional devices or venous access.
Haemonetics (NYSE: HAE) ha annunciato la certificazione CE Mark e le prime procedure commerciali europee per il suo SavvyWire® Pre-Shaped Pressure Guidewire. Questo dispositivo innovativo è la prima soluzione 3-in-1 al mondo per l'Impianto Transcatetere di Valvola Aortica (TAVI), offrendo un'efficienza procedurale migliorata grazie a prestazioni prevedibili del filo, misurazione emodinamica e capacità di stimolazione del ventricolo sinistro.
La certificazione consente a Haemonetics di entrare nei mercati dell'UE e in altre regioni che riconoscono il marchio CE. Le prime procedure commerciali europee sono state eseguite in Francia e nei Paesi Bassi. Il filo guida SavvyWire riduce gli scambi di dispositivi procedurali, fornisce una consegna stabile della valvola aortica e consente un monitoraggio emodinamico cardiaco continuo. Consente inoltre una stimolazione affidabile del ventricolo sinistro senza dispositivi aggiuntivi o accesso venoso.
Haemonetics (NYSE: HAE) ha anunciado la certificación CE Mark y los primeros procedimientos comerciales europeos para su SavvyWire® Pre-Shaped Pressure Guidewire. Este dispositivo innovador es la primera solución 3 en 1 del mundo para la Implantación de Válvula Aórtica Transcatéter (TAVI), ofreciendo una mejor eficiencia del procedimiento a través de un rendimiento predecible del cable, medición hemodinámica y capacidades de estimulación del ventrículo izquierdo.
La certificación permite a Haemonetics ingresar a los mercados de la UE y otras regiones que reconocen la marca CE. Los primeros procedimientos comerciales europeos se realizaron en Francia y los Países Bajos. El cable guía SavvyWire reduce los intercambios de dispositivos en el procedimiento, proporciona una entrega estable de la válvula aórtica y permite un monitoreo hemodinámico cardíaco continuo. También permite una estimulación confiable del VI sin dispositivos adicionales ni acceso venoso.
Haemonetics (NYSE: HAE)는 CE 마크 인증을 발표하고 SavvyWire® Pre-Shaped Pressure Guidewire의 첫 상업적 유럽 절차를 진행했습니다. 이 혁신적인 장치는 세계 최초의 3-in-1 솔루션으로, 경피적 대동맥 판막 이식(TAVI)을 위한 것으로, 예측 가능한 와이어 성능, 혈류역학적 측정 및 좌심실 자극 기능을 통해 절차 효율성을 향상시킵니다.
이 인증은 Haemonetics가 EU 시장과 CE 마크를 인정받는 다른 지역에 진입할 수 있도록 합니다. 첫 상업적 유럽 절차는 프랑스와 네덜란드에서 수행되었습니다. SavvyWire 가이드는 절차 장치 교환을 줄이고, 안정적인 대동맥 판막 전달을 제공하며, 지속적인 심장 혈류역학 모니터링을 가능하게 합니다. 또한 추가 장치나 정맥 접근 없이도 신뢰할 수 있는 좌심실 자극을 허용합니다.
Haemonetics (NYSE: HAE) a annoncé la certification CE et les premières procédures commerciales européennes pour son SavvyWire® Pre-Shaped Pressure Guidewire. Cet appareil innovant est la première solution 3-en-1 au monde pour l'Implantation Transcatheter de Valve Aortique (TAVI), offrant une efficacité procédurale améliorée grâce à des performances de fil prévisibles, des mesures hémodynamiques et des capacités de stimulation du ventricule gauche.
La certification permet à Haemonetics d'entrer sur les marchés de l'UE et d'autres régions reconnaissant le marquage CE. Les premières procédures commerciales européennes ont été réalisées en France et aux Pays-Bas. Le fil de guidage SavvyWire réduit les échanges d'appareils lors des procédures, fournit une livraison stable de la valve aortique et permet une surveillance hémodynamique cardiaque continue. Il permet également une stimulation fiable du VG sans appareils supplémentaires ni accès veineux.
Haemonetics (NYSE: HAE) hat die CE-Zertifizierung und die ersten kommerziellen europäischen Verfahren für seinen SavvyWire® Pre-Shaped Pressure Guidewire bekannt gegeben. Dieses innovative Gerät ist die erste 3-in-1-Lösung weltweit für die transkatheter Aortenklappenimplantation (TAVI) und bietet eine verbesserte Verfahrenseffizienz durch vorhersehbare Drahtperformance, hämodynamische Messungen und die Möglichkeiten zur Stimulation des linken Ventrikels.
Die Zertifizierung ermöglicht es Haemonetics, in die EU-Märkte und andere Regionen, die das CE-Zeichen anerkennen, einzutreten. Die ersten kommerziellen europäischen Verfahren wurden in Frankreich und den Niederlanden durchgeführt. Der SavvyWire-Führungsdraht reduziert die Austauschvorgänge von Geräten, bietet eine stabile Lieferung der Aortenklappe und ermöglicht eine kontinuierliche hämodynamische Überwachung des Herzens. Es erlaubt auch eine zuverlässige LV-Stimulation ohne zusätzliche Geräte oder venösen Zugang.
- Obtained CE Mark certification for SavvyWire® Pre-Shaped Pressure Guidewire
- First commercial European procedures performed in France and The Netherlands
- SavvyWire is the world's first 3-in-1 solution for TAVI procedures
- Reduces procedural device exchanges and enables continuous cardiac monitoring
- Allows for LV pacing without additional devices or venous access
- None.
Insights
The CE Mark certification for Haemonetics' SavvyWire® Pre-Shaped Pressure Guidewire represents a significant advancement in Transcatheter Aortic Valve Implantation (TAVI) procedures. This innovative 3-in-1 solution combines guidewire functionality, hemodynamic measurement and left-ventricular pacing capabilities, potentially streamlining TAVI procedures and reducing procedural complexity.
The device's ability to support multiple steps over the same guidewire could lead to fewer device exchanges, which may translate to shorter procedure times and reduced risk of complications. The continuous monitoring of cardiac hemodynamics throughout the procedure is a notable feature that could enhance real-time decision-making during TAVI.
Perhaps most intriguing is the SavvyWire's capacity for left-ventricular pacing without the need for additional devices or venous access. This feature could simplify the procedural workflow and potentially reduce the overall invasiveness of TAVI procedures.
From a market perspective, the CE Mark opens doors for Haemonetics in the European TAVI market, which is projected to grow significantly due to an aging population and increasing prevalence of aortic stenosis. The company's acquisition of OpSens Inc. in December 2023 appears strategically sound, as it has quickly led to this product launch in Europe.
However, it's important to note that market penetration will depend on factors such as pricing, reimbursement policies and the device's performance in real-world settings. The positive feedback from initial procedures in France and the Netherlands is encouraging, but broader adoption will require more extensive clinical evidence and potentially cost-effectiveness studies.
Haemonetics' announcement of CE Mark certification for the SavvyWire® guidewire is a positive development for the company's growth strategy in the interventional cardiology market. This certification allows Haemonetics to enter the European market with a unique product, potentially driving revenue growth in the region.
The TAVI market in Europe is substantial and growing. According to recent market research, the European TAVI market was valued at approximately
The acquisition of OpSens Inc. in December 2023 is now bearing fruit, demonstrating Haemonetics' ability to integrate and commercialize acquired technologies effectively. This success could boost investor confidence in the company's M&A strategy and its ability to diversify its product portfolio.
However, it's important to consider that the financial impact of this product launch may not be immediate. Market penetration takes time and the sales ramp-up will depend on factors such as physician adoption rates, pricing strategies and competition from established players in the TAVI space.
Investors should monitor key performance indicators in the coming quarters, including:
- Revenue contribution from the SavvyWire guidewire
- Gross margins on the new product
- Market share gains in the European TAVI market
- R&D expenses related to potential future iterations of the device
While this development is promising, it's important to view it in the context of Haemonetics' overall financial performance and its position in the broader medical technology market.
The certification will allow Haemonetics, which added the SavvyWire guidewire to its product portfolio with its acquisition of OpSens Inc. in December 2023, to engage in the next steps of country-specific entrance of the SavvyWire guidewire into the European Union (EU) and other geographies that recognize CE marking. The first commercial European procedures using the SavvyWire guidewire were performed this month at Hôpital Haut-Lévêque du Centre Hospitalier Universitaire (CHU) de
The SavvyWire guidewire is engineered to uniquely support multiple steps over the same guidewire, reducing procedural device exchanges, providing stable aortic valve delivery and positioning while continuously monitoring cardiac hemodynamics. Additionally, it has been designed to enable reliable LV pacing without need for adjunct devices or venous access for conventional right ventricular pacing during TAVI procedures.
"More than 20 years after the first introduction of TAVI in
According to Professor Pim Tonino from Catharina Ziekenhuis Eindhoven, "The SavvyWire guidewire raises the standard for hemodynamic measurements throughout the TAVI procedure, enabling physicians to make important procedural decisions immediately without having to exchange devices."
"CE Mark certification for the SavvyWire guidewire is a key step in our strategic international expansion, as we continue to broaden our leadership and impact by creating greater access to critical interventional technologies that advance healthcare standards," said Stewart Strong, President, Global Hospital at Haemonetics. "We look forward to leveraging our strong global commercial infrastructure to bring the SavvyWire guidewire's fiber optic sensor technology to
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. Haemonetics' Global Hospital business provides a range of solutions to address the needs of hospitals, including Interventional Technologies for electrophysiology and interventional cardiology, and Blood Management Technologies that include diagnostics to help inform treatment decisions, technologies to help avoid unnecessary allogeneic transfusions and solutions to help optimize management of blood products. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking Information
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the SavvyWire guidewire and Haemonetics' plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of global economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the
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FAQ
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