Anteris’ DurAVR Biomimetic TAVR Device Studied to Treat Symptomatic AS Patients

May 3, 2024—The safety and feasibility of the biomimetic DurAVR transcatheter heart valve system (Anteris Technologies) in the treatment of patients with severe symptomatic aortic stenosis (AS) were evaluated in a prospective nonrandomized, single-arm, single-center, first-in-human (FIH) study of 28 patients.

Clinical, echo, CT, and cardiac MRI assessments were performed for up to 1 year. The study showed positive results in the device’s ability to function as a healthy and natural aortic valve in patients with AS.

The late-breaking data were presented at SCAI 2024, the Society for Cardiovascular Angiography & Interventions scientific sessions held May 2-4 in Long Beach, California. The abstract of the study findings by Christopher Meduri, MD, et al is available online in JSCAI.

As summarized in the SCAI press release, the DurAVR valve was successfully implanted in 100% of the cases, and all patients showed excellent post-procedural hemodynamic results despite a small mean annulus size. No moderate or severe paravalvular leak was observed. Additionally, laminar flow was consistently displayed on cardiac MRI.

For those patients at 12-month follow-up, the valve also showed a favorable safety profile in all patients, and no valve-related complications, strokes, life-threatening bleeding, or reoperations occurred, reported the SCAI press release.

“We are excited to share such favorable results early on in our trial as it represents a novel option for TAVR procedures by providing encouraging evidence of improved hemodynamics and normalized blood flow characteristics associated with the system,” commented study investigator Azeem Latib, MD, in the SCAI press release.

Dr. Latib, who is Director of Interventional Cardiology and Structural Heart Interventions at Montefiore Medical Center in New York, New York, added, “We look forward to sharing additional results that support the valve performance characteristics and how similar they are to the ones of a healthy aortic valve.”