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

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init