Conformal Medical announced the initiation of a study assessing intracardiac echocardiography (ICE) imaging appendage closure procedures.

The GLACE study looks at ICE imaging of the left atrial appendage (LAA) during closure devices with the next-generation CLAAS AcuForm device. It evaluates this combination in patients with non-valvular AFib.

Conformal Medical plans for the study to enroll around 80 patients across Denmark, Italy and the Czech Republic. Co-principal investigators Dr. Jens Erik Nielsen-Kudsk and Dr. Ole De Backer, both in Denmark, treated the initial patients. The company also reported Dr. Shephal Doshi of California, principal investigator of its CONFORM pivotal trial, as present for the cases.

“I am excited about the new CLAAS AcuFORM implant and the ability to confirm seal with angiography providing procedural confidence, ensuring the patient has been properly treated,” stated Nielsen-Kudsk. “ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology.”

According to Conformal Medical, ICE imaging facilitates real-time visualization of cardiac structures during LAAO closure. This enhances precision while reducing radiation exposure and procedure time.

Conformal Medical designed its CLAAS AcuForm LAAO system to build upon the novel CLAAS device. It conforms and seals the LAA with its proprietary foam-based architecture. The implant aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia.

“The use of ICE imaging in LAAO is growing significantly and will continue,” said James Reinstein, president and CEO of Conformal Medical. “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.”