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Conformal Medical Initiates GLACE Study for Next-Gen LAAO Device with ICE Imaging

• Conformal Medical has begun its GLACE study to assess the use of intracardiac echocardiography (ICE) imaging during left atrial appendage occlusion (LAAO) procedures using the CLAAS AcuForm device. • The GLACE study aims to enroll approximately 80 patients across multiple European sites to validate the use of ICE with the innovative LAAO technology in patients with non-valvular AFib. • The CLAAS AcuForm LAAO system is designed to conform and seal the LAA, simplifying delivery and potentially eliminating the need for general anesthesia during the procedure. • ICE imaging offers real-time visualization, enhancing precision and potentially reducing radiation exposure and procedure time during LAAO closure.

Conformal Medical has announced the start of the GLACE study, which will evaluate the use of intracardiac echocardiography (ICE) imaging during left atrial appendage occlusion (LAAO) procedures using the next-generation CLAAS AcuForm device in patients with non-valvular atrial fibrillation (AFib). The study aims to demonstrate the safety and efficacy of this combination, potentially simplifying the LAAO procedure and improving patient outcomes.
The GLACE study plans to enroll around 80 patients across sites in Denmark, Italy, and the Czech Republic. The first patients were treated by co-principal investigators Dr. Jens Erik Nielsen-Kudsk and Dr. Ole De Backer in Denmark. Dr. Shephal Doshi, principal investigator of Conformal Medical's CONFORM pivotal trial, was also present for the initial cases.

Benefits of ICE Imaging in LAAO

According to Conformal Medical, ICE imaging provides real-time visualization of cardiac structures during LAAO closure. This enhanced visualization can lead to increased precision during the procedure, while also reducing radiation exposure and overall procedure time. Dr. Nielsen-Kudsk stated, "ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology."

CLAAS AcuForm LAAO System

The CLAAS AcuForm LAAO system builds upon the original CLAAS device, utilizing a proprietary foam-based architecture to conform and seal the LAA. The design aims to simplify the delivery process and potentially eliminate the need for procedural transesophageal echocardiogram (TEE), allowing physicians to perform the procedure without general anesthesia. James Reinstein, president and CEO of Conformal Medical, noted, "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation."

Clinical Implications

The GLACE study could pave the way for wider adoption of ICE imaging in LAAO procedures, potentially leading to safer and more efficient interventions for patients with non-valvular AFib at risk of stroke. If successful, the CLAAS AcuForm system, combined with ICE imaging, could offer a less invasive alternative to traditional LAAO techniques, improving the overall patient experience.
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Reference News

[1]
Conformal Medical kicks off left atrial appendage occlusion device trial - MassDevice
massdevice.com · Oct 2, 2024

Conformal Medical initiates GLACE study to assess ICE imaging during LAAO closure with CLAAS AcuForm device in non-valvu...

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