Veryan Medical recently announced the US launch and first commercial implant in the USA of the BioMimics 3D vascular stent system.
According to a press release, the BioMimics 3D self-expanding, nitinol stent features a highly-differentiated, helical centre-line design that has achieved excellent clinical outcomes in clinical trials, including a pivotal study with three-year follow-up.
Nick Yeo, Veryan’s CEO commented: “Launching BioMimics 3D in the USA marks a significant landmark for Veryan. In preparation for this important commercial step, we have recruited a senior sales team, highly experienced in percutaneous vascular intervention, led by Joe DeJohn, Veryan’s US-based, chief commercial officer. I am confident that in building our commercial organisation on such strong networked foundations, supported by a major, real-world registry study that we expect to launch in USA next quarter, we will quickly establish BioMimics 3D as the go-to stent for femoropopliteal intervention in the USA.”
On the same day that Veryan launched the device in the USA, Bret Wiechmann and his team at Vascular and Interventional Physicians in Gainesville, USA implanted the first commercial BioMimics 3D Vascular stent in the country.
Wiechmann commented: “We are thrilled to have the opportunity to implant the first BioMimics 3D stent in the USA in anticipation of the full commercial launch. The three-dimensional, helical design is unique in this stent category and has demonstrated promising results, as evidenced by the recent release of the three-year follow up from the IDE [investigational device exemption] pivotal study. The femoropopliteal segment still represents a significant challenge in the treatment of patients with peripheral arterial disease, driven by a concern for long-term durability and improved efficacy. We are excited to be able to offer this unique stent as part of our treatment algorithm to help address these challenges.“
A press release details that the benefits of the BioMimics 3D stent design have been well established in the MIMICS clinical research programme, enrolling more than 1,750 patients worldwide.
The most recent findings are the three-year follow-up data from the MIMICS-2 study which were presented by Thomas Zeller (University Heart Center Freiburg, Bad Krozingen, Germany) at CX 2020 Live in June.
MIMICS-2 is a prospective, single-arm, multicentre study that evaluated the safety and effectiveness of the BioMimics 3D vascular stent system in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery.
Zeller reported at CX 2020 that the three-year freedom from clinically-driven target lesion revascularisation (CDTLR) for BioMimics 3D was 81%; a result that is comparable to outcomes with drug-coated and latest generation bare nitinol stents, despite treating more challenging lesions and without the need for lesion preparation. BioMimics 3D thus provides increased procedural simplicity for physicians, and durable, long-term clinical outcome benefit for patients.
Zeller commented: “I have been using BioMimics 3D routinely in my clinical practice for several years and I am delighted that my US colleagues will also now have this opportunity. The three-dimensional helical shape of the stent promotes swirling blood flow, a protective phenomenon that occurs naturally in the vasculature, but which can be disrupted, predisposing to atherosclerotic disease and neointimal formation at the site of vascular intervention that can lead to restenosis and the need for reintervention.
“Data from the MIMICS clinical programme, including those from our MIMICS Rrandomised clinical trial, comparing the performance of the helical-shaped BioMimics 3D to that of a straight stent, support the clinical benefits of Veryan’s unique stent design that promotes swirling blood flow and improves biomechanical performance in the stented segment.
“I am sure that the stent will not just be a valuable addition to my US colleagues’ treatment options, but for many will become their primary therapy for femoropopliteal disease.”