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2026 AF Symposium
Spotlight Session: AcuFORM—New Left Atrial Appendage Occlusion (LAAO) Device
Spotlight Session: AcuFORM—New Left Atrial Appendage Occlusion (LAAO) DeviceThe AF Symposium Spotlight Session features “New and Emerging Technologies in EP.” This year there were 11 presentations of 5 minutes each. Frequently, a talk about a new technology will appear next year at the AF Symposium as a full-blown presentation. My first review is on a Left Atrial Appendage Occlusion device in Clinical Trial.
Shephal Doshi, MD
Dr. Shephal Doshi (Pacific Heart Institute, Santa Monica, CA) gave a talk on a new Left Atrial Appendage Occlusion (LAAO) device (CLAAS® AcuFORM™ from Conformal Medical).
As compared to other LAAO devices already FDA-approved and on the market, the AcuFORM uses a foam-based cover/fabric (Cortex) to close off the LAA. This foam-based conformable cover has no exposed metal and is non-permeable.
It can be squeezed and made to conform to different LAA openings. There is no need for multiple sizes of the device. Over 90% of installations were accomplished with one regular size.
Illustration: AcuForm LAAO device from Conformal Medical
When installed, it completely closes off the LAA. Unlike other LAA occlusion devices, it can be tested right away. There is no need to wait till heart tissue grows over the device.
It’s installed using a deflectable sheath with 5-way steering which looks easy to use.
CONFORM Clinical Trial
The FDA approved CONFORM Pivotal Trial is evaluating the safety and efficacy of the CLAAS® AcuFORM™ Implant compared to other commercially available Left Atrial Appendage Occlusion (LAAO) devices in patients with non-valvular Atrial Fibrillation.
The Conform clinical trial will enroll 1,600 patients who will be followed up for 18 months. Participating in the trial are 65 centers.
Of the two study groups, one will receive the CLAAS AcuFORM implant, while the second will receive a commercially available implant. Enrollment has started. To enroll in this clinical trial, contact your cardiologist or electrophysiologist. To learn more, go to: https://conformalmedical.com/patient/enroll-in-trial, or write to: info@conformalmedical.com.
Editor’s Comments
Editor’s CommentsMajor Improvement: The AcuFORM Left Atrial Appendage Occlusion (LAAO) device looks to be a major improvement over current LAAO devices. Key benefits:
· There is no exposed metal
· It provides a complete seal without leaks from day one
· Because it is foam based, it can be squeezed and made to conform to most anatomies
· It’s easy to install
· Because of its ability to adapt to different anatomies, there is no need for multiple sizes
Future Bright For AcuFORM: Though it still must get FDA approval, the AcuFORM device looks like a medical breakthrough for patients and doctors.
I predict it will get FDA approval and will become the go-to method of closing off the Left Atrial Appendage.
See How it Works: Click here to see a video animation of the AcuFORM insertion into the left atrial appendage. (Audio playback: Be sure that the speaker icon is on—the lower right corner of the video screen.)
