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3-D nitinol stent maintained primary patency at 2 years
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Two-year data from the Mimics study demonstrated that a nitinol stent with 3-D helical geometry provided significant improvement in long-term primary patency compared with a straight nitinol control stent in patients undergoing femoropopliteal artery intervention.
The data were presented at VIVA 14.
The prospective, multicenter trial included 76 patients who were randomly assigned in a 2:1 ratio to femoropopliteal intervention with the BioMimics 3-D nitinol stent (Veryan Medical; n=50) or the LifeStent (Bard Peripheral Vascular; n=26), a straight nitinol stent, which served as a control group.
The BioMimics stent is designed to replicate natural vascular curvature to promote secondary blood flow and increase hemodynamic shear stress. The stent also is designed to enhance biomechanical performance of the stented segment, according to a press release.
At 2 years, Kaplan-Meier survival estimates of freedom from loss of primary patency were 72% for patients assigned the BioMimics stent vs. 55% for patients assigned the control stent (P=.0497). During his presentation, principal investigator Thomas Zeller, MD, from Universitäts–Herzzentrum, Freiburg–Bad Krozingen, Germany, said this difference was observed despite the insufficient power of this study to result in a significant outcome for its primary endpoint. All BioMimics stents with a mean curvature of at least 0.02 mm-1 maintained patency, and no patients in the test group experienced stent fracture, according to a press release.
At 2 years, the Kaplan-Meier survival estimate from clinically driven target lesion revascularization was 91% for patients assigned the BioMimics stent vs. 76% for patients assigned the control stent (P=.135). However, results of a 12-month landmark analysis indicated a significant difference between the groups regarding the Kaplan-Meier survival estimate for clinically driven TLR between 1 and 2 years after the procedure (P=.0263).
Zeller said in prior studies assessing various other stents, including Zilver PTX (Cook Medical), Supera (Abbott) and LifeStent, freedom from clinically driven revascularization decreased between 1 and 2 years, but this was not observed in this study of patients assigned the BioMimics stent.
“These data suggest the existence of a patency-protective effect provided by the biomimetic characteristics of the BioMimics 3-D nitinol stent, resulting in hemodynamic and biomechanical performance advantages over straight nitinol stents,” Zeller said in a press release.
According to the release, the company has received CE mark approval for BioMimics 3-D. Commercialization of the device is expected to begin during the first quarter of 2015. The stent is not currently available for sale or investigational use in the United States.
For more information:
Zeller T. Late-Breaking Clinical Trials. Presented at: VIVA 14; Nov. 4-7, 2014; Las Vegas.
Disclosure: Zeller reports serving as a paid consultant and on an advisory board for Veryan.
Perspective
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Michael R. Jaff, DO
With the improving data emerging in peripheral artery disease therapies, the BioMimics 2-year data presented at VIVA 2014 provide some interesting insights into this novel device. Of interest is the lack of clinically-driven TLR with the curved BioMimics stent from 12 to 24 months. In addition, the researchers demonstrated improved patency when arteries maintained a curve, supporting the concept that the curved aspect of the stent promotes improved patency. A larger-scale study is needed across multiple centers in order to confirm these findings.Click Here to Manage Email Alerts