Veryan’s MIMICS-3D EU 3-Year Results Presented

January 22, 2022—Veryan Medical Ltd., an Otsuka Medical Devices company, advised that the 3-year results of the MIMICS-3D European Union (EU) study were presented by Principal Investigator Michael Lichtenberg, MD, at ISET 2022, the International Symposium on Endovascular Therapy held January 16-19 in Hollywood, Florida.

The MIMICS-3D EU is a prospective, multicenter, observational registry to evaluate the company’s BioMimics three-dimensional (3D) vascular stent system. The study evaluated safety, effectiveness, and device performance within a real-world clinical population of 507 patients enrolled at 23 sites in Europe. The BioMimics 3D vascular stent system has CE Mark approval in Europe and is approved in the United States and Japan.

According to the company, the mean age of enrolled patients was 70 years; 66% were male, and 37% were diabetic. Patients in Rutherford class 0-1, 2-4, and 5-6 were 1%, 82%, and 17%, respectively. Mean lesion length was 126 mm, and 57% of lesions were occlusions. Lesion calcification per Peripheral Arterial Calcium Scoring System was grade #0 in 18%, #1 in 30%, #2 in 24%, #3 in 15%, #4 in 14% of lesions.

BioMimics 3D placement followed atherectomy in 8% of lesions. Drug-coated balloons were combined with BioMimics 3D in 50% of lesions treated. Technical success for the BioMimics 3D implant procedure as assessed by the operator was 99%.

An independent clinical events committee adjudicated major adverse events (MAE), including death and potential device-related events.

Veryan reported that the primary safety endpoint was a composite of MAE (death, major index limb amputation, or clinically driven target lesion revascularization [CD-TLR]) through 30 days. The primary outcome measure for effectiveness was freedom from CD-TLR through 12 months.

The Kaplan-Meier (KM) estimate of freedom from CD-TLR at 1, 2, and 3 years in the intention-to-treat (ITT) population was 90%, 82%, and 78%, respectively. The KM estimate of freedom from loss of primary stent patency (PSVR > 2.4) through 3 years in the ITT population was 71%. There were 4/676 (0.6%) site-reported stent fractures.

“I have been using BioMimics in my daily clinical practice for 7 years, and it is my ‘go-to’ stent for a number of different indications, including long lesions, calcified lesions, and lesions located in the distal superficial femoral artery and proximal popliteal,” commented Dr. Lichtenberg in the company’s press release. “I was delighted to be the principal investigator for the MIMICS-3D study and am pleased that the results further validate earlier results from the MIMICS clinical program, the combined database of which provides significant validation of the clinical benefits of swirling flow.”