News | Left Atrial Appendage (LAA) Occluders | February 27, 2023

Study Demonstrates Successful Device Size Selection When Assessing Left Atrial Appendage by Angiography Compared to TEE

Data from "Real-Time Atrial Appendage Assessment for LAAO-CLAAS Device Selection: Angiography vs TEE" was presented at Cardiovascular Research Technologies Conference (CRT) 

Data from "Real-Time Atrial Appendage Assessment for LAAO-CLAAS Device Selection: Angiography vs TEE" was presented at Cardiovascular Research Technologies Conference (CRT)

February 27, 2023 — Conformal Medical, Inc. announced today the results from the CONFORMAL Early Feasibility Study (EFS), evaluating the use of angiography compared to transesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment. The findings were presented at this year's Cardiovascular Research Technologies Conference (CRT 2023) in Washington, DC by Dr. William Gray, co-Director of the Lankenau Heart Institute and Professor of Medicine at Thomas Jefferson University during the Left Atrial Appendage Closure Forum

"This study evaluated baseline TEE and angiographic data collected from 36 atrial fibrillation (AFib) patients who were deemed appropriate for left atrial appendage occlusion (LAAO)," stated Dr. Gray. "The complete paired images were analyzed for LAA diameter and depth to facilitate CLAAS device size selection. Results demonstrated a 97% agreement in device size selection between the two imaging modalities." 

The CLAAS System is designed to seal the LAA in patients with non-valvular AFib to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the implant addresses a wide spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural TEE so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same day, single operator procedure. 

"The novel CLAAS device is designed to streamline LAAO procedures," commented Dr. Aaron Kaplan, professor of medicine at Dartmouth and co-founder and chief medical officer for Conformal Medical. "This study demonstrates that with only two sizes, the CLAAS implant requires minimal imaging, an important step as we look to transform the procedure to a single operator, same day procedure." 

Conformal Medical is actively enrolling patients in the CONFORM pivotal trial, evaluating the safety and efficacy of the CLAAS System compared to other commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the U.S. and will support U.S. Food and Drug Administration (FDA) pre-market approval. 

For more information: https://conformalmedical.com/ 


Related Content

News | Left Atrial Appendage (LAA) Occluders

April 4, 2024 — Osso VR, a leader in immersive procedural training, announces the release of a co-developed curriculum ...

Home April 04, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

March 18, 2024 — Conformal Medical, Inc. announced that the CLAAS System was featured in a podium presentation at the ...

Home March 18, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

January 8, 2024 — University Hospitals (UH) Harrington Heart & Vascular Institute recently became the first center in ...

Home January 08, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

October 25, 2023 — ConcertAI's TeraRecon, a leader in advanced visualization and artificial intelligence (AI) for ...

Home October 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

October 25, 2023 — Findings from a trial led by Cleveland Clinic show that patients with atrial fibrillation undergoing ...

Home October 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

October 19, 2023 — Conformal Medical, Inc. announced today the one-year results from the company's CONFORMAL Early ...

Home October 19, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

September 7, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration approval ...

Home September 07, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

July 26, 2023 — Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to ...

Home July 26, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

May 25, 2023 — Boston Scientific Corporation announced data supporting use of the company's key electrophysiology and ...

Home May 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

May 22, 2023 — Boston Scientific Corporation announced data supporting use of the company's key electrophysiology and ...

Home May 22, 2023
Home
Subscribe Now