Sam Brusco, Associate Editor06.20.22
Next-gen left atrial appendage occlusion (LAAO) firm Conformal Medical has begun its CONFORM U.S. IDE study to evaluate its CLAAS system compared to commercially available LAAO devices.
The trial will be used to support U.S. Food and Drug Administration (FDA) premarket approval.
"I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (Afib)," Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research and trial investigator, told the press. "In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal and incidence of device-related thrombus."
The study will enroll about 1,600 patients in the U.S., Canada, and Japan. Over 75 patients have thus far been successfully implanted with the CLASS system as part of early feasibility studies.
"Based on our experience in the Early Feasibility Study, the CLAAS System is highly conformable to accommodate different anatomies," said Dr. Shephal Doshi, Executive Director, Heart & Vascular Institute, Prov. St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute. "The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients."
CLAAS seals the LAA in non-valvular AFib patients to lower stroke risk without anticoagulants. The implant features a foam-based architecture, making it able to address a variety of LAA anatomies with only two sizes.
Conformal aims for the CLAAS system to simplify delivery and remove need for transesophageal echocardiogram, so the procedure can be performed under general anesthesia.
"We are pleased to enroll the first patients in the CONFORM trial, an important milestone for the company. Kicking off the study builds on the strong momentum from our EFS experience," commented Andy Levine, President and CEO of Conformal Medical. "This IDE includes the rigor of both a randomized study comparing CLAAS to commercial devices, and a separate sub-study designed to support a conscious sedation, ICE-driven approach; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants."
The trial will be used to support U.S. Food and Drug Administration (FDA) premarket approval.
"I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (Afib)," Dr. William Gray, System Chief, Cardiovascular Diseases at Main Line Health and professor at Lankenau Institute for Medical Research and trial investigator, told the press. "In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal and incidence of device-related thrombus."
The study will enroll about 1,600 patients in the U.S., Canada, and Japan. Over 75 patients have thus far been successfully implanted with the CLASS system as part of early feasibility studies.
"Based on our experience in the Early Feasibility Study, the CLAAS System is highly conformable to accommodate different anatomies," said Dr. Shephal Doshi, Executive Director, Heart & Vascular Institute, Prov. St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute. "The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients."
CLAAS seals the LAA in non-valvular AFib patients to lower stroke risk without anticoagulants. The implant features a foam-based architecture, making it able to address a variety of LAA anatomies with only two sizes.
Conformal aims for the CLAAS system to simplify delivery and remove need for transesophageal echocardiogram, so the procedure can be performed under general anesthesia.
"We are pleased to enroll the first patients in the CONFORM trial, an important milestone for the company. Kicking off the study builds on the strong momentum from our EFS experience," commented Andy Levine, President and CEO of Conformal Medical. "This IDE includes the rigor of both a randomized study comparing CLAAS to commercial devices, and a separate sub-study designed to support a conscious sedation, ICE-driven approach; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants."
