Technology | Stents Peripheral | October 05, 2018

Veryan Medical's BioMimics 3D Stent Receives PMA Approval

Three-dimensional helical shape of peripheral stent designed to promote swirling flow and elevate wall shear

Veryan Medical's BioMimics 3D Stent Receives PMA Approval

October 5, 2018 — Veryan Medical Ltd has received Premarket Approval (PMA) for the BioMimics 3D Vascular Stent System from the U.S. Food & Drug Administration (FDA). The device is approved for the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.

The BioMimics 3D stent has a three-dimensional helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, to promote swirling flow and elevate wall shear, which has a protective effect on the endothelium.1,2, 3 The helical shape of the stent is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury.5, 6

Key components of the PMA application were the 12-month interim safety and effectiveness results from the company’s MIMICS-2 clinical study. The study was conducted under an FDA-approved Investigational Device Exemption (IDE) in patients with peripheral arterial disease (PAD) undergoing endovascular intervention in the femoropopliteal artery.

The company said BioMimics 3D represents an innovative approach to the requirement for durable support for the arterial lumen after intervention. The helical centerline stent is designed to not only promote swirling blood flow but also to accommodate the complex biomechanical challenge associated with stenting this anatomically mobile artery.

The MIMICS-2 study enrolled 271 subjects across 43 investigational sites in the U.S., Japan and Germany. The principal investigators are Timothy M. Sullivan, M.D., Minneapolis; Masato Nakamura, M.D., Ph.D., Tokyo, Japan; and Thomas Zeller, M.D., Bad Krozingen, Germany.

Both primary endpoints in the MIMICS-2 study, safety and effectiveness, were met. Freedom from major adverse events at 30 days was 99.6 percent (268/269) and Kaplan-Meier (KM) estimates of freedom from loss of primary patency and clinically-driven target lesion revascularization (CDTLR), were 83 percent and 88 percent, respectively, at 12 months; no stent fractures were detected in core laboratory imaging review.4                

For more information: www.veryanmed.com

 

References

  1. Zeller T. - Oral Presentation VIVA 2014
  2. Malek, JAMA, 282, p 2035-2042, 1999
  3. Zeller T. et al; Circ Cardiovasc lnterv. 2016;9:e002930. DOI: 10.1161 2
  4. Data on file at Veryan Medical
  5. BH Smouse et al, Endovasc. Today, vol 4, no. 6, pp. 60-66, 2005
  6. Scheinert D et al, J Am Coll Cardiel 2005;45:312-5 doi:10.1016/j.jacc.2004.11.026

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...