The CLAAS System features the company’s unique foam-based architecture to seal the LAA in patients with non-valvular atrial fibrillation (AFib) to reduce the risk of stroke without using anticoagulants and eliminate the need for procedural TEE
Conformal Medical's CLAAS Implant. (Credit: PRNewswire/Conformal Medical, Inc.)
US-based medical device company Conformal Medical has announced positive results for its CLAAS System from the CONFORMAL Early Feasibility Study (EFS).
The EFS evaluated the use of angiography compared to transoesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment.
The CLAAS System is intended to seal the LAA in patients with non-valvular atrial fibrillation (AFib) to reduce the risk of stroke without using anticoagulants.
It features the company’s unique foam-based architecture and addresses a wide spectrum of LAA anatomies with only two sizes.
The implant system is designed to simplify delivery and eliminate the need for procedural TEE, allowing physicians to perform the procedure without general anaesthesia.
It can transform the left atrial appendage closure into a same day, single operator procedure, said the company
Thomas Jefferson University professor of medicine Dr William Gray said: “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).
“The complete paired images were analysed 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.”
Conformal Medical is engaged in developing devices that prevent stroke in patients with non-valvular AFib.
Earlier this month, the company unveiled one-year data from the study of LAAO cases using its CLAAS System in patients under conscious sedation without general anaesthesia.
Currently, the company is actively recruiting patients in the CONFORM trial, designed to evaluate the safety and efficacy of the CLAAS System compared to other LAAO devices.
The multicentre, randomised controlled study will enrol around 1,600 patients in the US and will support US Food and Drug Administration (FDA) pre-market approval.
Conformal co-founder and chief medical officer, and Dartmouth Medical professor of medicine Dr Aaron Kaplan said: “The novel CLAAS device is designed to streamline LAAO procedures.
“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.”