Blog

Oct 16, 2024

AtriCure Gets CE Mark for EnCompass Clamp, Expands in Europe

AtriCure, Inc. ATRC, a leading innovator in surgical treatments for atrial fibrillation (Afib), has announced regulatory approval for its EnCompass Clamp in CE-marked countries within the European

AtriCure, Inc. ATRC, a leading innovator in surgical treatments for atrial fibrillation (Afib), has announced regulatory approval for its EnCompass Clamp in CE-marked countries within the European Union.

European surgeons have already performed the first series of cases using the device. Initially launched in the United States in 2022, the EnCompass Clamp is designed to streamline heart ablation during open-chest surgeries.

The EnCompass Clamp incorporates key features of AtriCure’s Synergy Clamp family, including parallel closure, uniform pressure and custom power delivered through Synergy radiofrequency technology. The EnCompass Clamp is specifically designed to fit cardiac anatomy, enabling surgical ablation in procedures like Coronary Artery Bypass Grafting and Aortic Valve Replacement, where the atrium typically remains closed.

AtriCure's FDA-approved solutions include the Isolator Synergy Ablation System for persistent Afib, the AtriClip for left atrial appendage management, and Hybrid AF Therapy, a minimally invasive option for long-standing Afib. AtriCure also offers cryoICE cryoSPHERE probes for pain management in cardiac and thoracic surgeries, solidifying its position in advancing cardiac care.

Per AtriCure, the CE mark approval for the EnCompass Clamp marks a significant milestone for AtriCure, expanding its product availability internationally. The clamp allows for faster, more efficient heart ablation, reducing tissue dissection and improving procedural outcomes.

Its success in the United States over the past two years has demonstrated a positive impact on advancing treatments during cardiac surgeries. By offering this innovative technology to European patients and surgeons, AtriCure strengthens its global presence and supports the 400,000 annual cardiac surgeries in the European Union, enhancing patient outcomes and surgical efficiency.

AtriCure management highlighted the launch of the EnCompass Clamp in Europe as a major international expansion of their product line.

Per a report in Precedence Research, the global cardiac ablation market size was worth $4.07 billion in 2023. It is anticipated to reach $14.51 billion by 2033 at a CAGR of 13.6%.

The robust growth is likely to be driven by advancements in minimally invasive surgical techniques. Radiofrequency ablation has emerged as the forefront treatment.

Some other companies from the medical products industry making notable developments in their respective businesses are Medtronic Plc MDT, GE HealthCare Technologies Inc. (GEHC) and Boston Scientific Corporation (BSX).

Medtronic is a leading global healthcare technology company offering innovative technologies and therapies for 70 health conditions, including cardiac devices, surgical robotics, insulin pumps and patient monitoring systems, transforming lives every second.

In June, Medtronic expanded its Cardiovascular business, driven by strong growth in Cardiac Rhythm Management and Cardiac Pacing following the launch of its Micra AV2 and VR2 devices. The company is also gaining market share in Transcatheter Aortic Valve Replacement with the recent FDA approval of its Evolut FX Plus valve.

GE HealthCare focuses on personalized and connected care across its Imaging, Ultrasound, Patient Care Solutions and Pharmaceutical Diagnostics sectors.

In August, GE HealthCare received the CE mark for two innovative technologies: the Vscan Air SL wireless handheld ultrasound with Caption AI and ECG-less cardiac CT scanning on its Revolution Apex platform. The Vscan Air SL enables rapid cardiac assessments with AI-driven guidance, allowing non-experts to capture high-quality heart images. The ECG-less cardiac CT system simplifies cardiac imaging by eliminating the need for ECG signals and hence improving speed and accessibility for clinicians.

Boston Scientific offers a diverse portfolio of high-performance devices and therapies that support physicians in diagnosing and treating complex conditions across cardiovascular, respiratory, digestive, oncological, neurological, and urological disciplines while also reducing healthcare costs.

Last month, Boston Scientific received approval in Japan for its FARAPULSE Pulsed Field Ablation (PFA) System, which is used to treat paroxysmal atrial fibrillation (AF) by isolating pulmonary veins. The non-thermal PFA system, already used in over 125,000 patients globally, provides a safer alternative to thermal ablation. Now approved in over 65 countries, it marks a significant shift in AF treatment, benefiting both physicians and patients.

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