News | Cardiovascular Clinical Studies | February 01, 2018

12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC

These MIMICS-2 results reinforce the results of the company’s earlier MIMICS-RCT study in a larger, more challenging patient population, according to one of the investigators.

12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC

February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS-2 IDE study, a prospective, single-arm, multi-center clinical study to evaluate the safety and effectiveness of the BioMimics 3-D Vascular Stent System in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery. Conducted under an FDA Investigational Device Exemption (IDE) with the concurrence of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) under the FDA/PMDA Harmonisation By Doing collaboration, MIMICS-2 enrolled 271 subjects undergoing femoropopliteal intervention across 43 investigational sites in the U.S., Japan and Germany.

Zeller, who along with Timothy Sullivan (Minneapolis, USA) and Professor Masato Nakamura (Tokyo, Japan) is a co-principal investigator, presented the MIMICS-2 12-month safety and efficacy data at LINC 2018 in Leipzig, Germany.  He announced for the first time that both the primary safety and effectiveness endpoints were met; there were no stent fractures; the Kaplan-Meier estimate of freedom from loss of primary patency at 12 months was 81.9 percent at day 365 and the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD TLR) at 12 months was 88.8 percent. He commented further that these MIMICS-2 results reinforce the results of the company’s earlier MIMICS-RCT study in a larger, more challenging patient population. The BioMimics 3-D primary patency result at 12 months is similar to those reported for drug-eluting stents and drug-coated balloons which suggests that natural swirling flow is an alternative to antiproliferative drugs.

For more information: www.veryanmed.com

Related Content

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...