Technology | Stents Peripheral | December 31, 2015

FDA Clears Peripheral Stent from Biotronik

Biotronik Astron stent

December 31, 2015 - The U.S. Food and Drug Administration (FDA) has cleared Biotronik's Astron Peripheral Self-Expanding Nitinol Stent System. The device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3 and 9.5 mm and lesion lengths up to 105 mm. 

The Astron stent system is a self-expanding stent loaded on an over-the-wire delivery system. The stent is laser-cut from a nitinol tube. It carries four radiopaque extensions at each end and is completely coated with amorphous silicon carbide (a-SiC:H). The delivery system consists of two coaxially arranged elements: the inner shaft  and the outer sheath. The inner shaft is made of a thermoplastic polymer. At the proximal end, it is covered with a stainless steel tube. The safety tab that covers the stainless steel tube prevents accidental stent release. The stainless steel tube incorporates a black release marker that indicates the completion of stent deployment and ends with a luer port at the proximal guide wire exit. 

The central guide wire lumen within the inner shaft continues to the radiopaque tip. The stent is mounted between the inner shaft and the outer sheath proximal to the tip, between two radiopaque markers, which facilitate fluoroscopic visualization, and positioning of the delivery system towards and across the lesion. The outer sheath begins within the T-connector and extends towards the tip. It covers the stent and keeps it constrained within its distal end. A hydropholic coating is applied to the inside and outside of the entire outer sheath. The annular space between the inner shaft and the outer sheath can be flushed through the luer port at the T-connector. The guide wire lumen of the inner shaft is flushed through the luer port at the proximal guide wire exit. The guide wire lumen permits the use of 0.035” guide wires to facilitate advancement of the delivery system through the lesion to be treated. The stent system is shipped with an “Easy Release”-tube inserted over the proximal outer sheath. The “Easy Release” tube is intended to be inserted into the hemostatic valve of the introducer to reduce friction between the delivery system and the hemostatic valve during stent release. The stent system and the Easy Release tube are compatible with an appropriately sized introducer sheath according to the indications on the label. The stent is advanced to the intended implantation location by means of the over-the-wire delivery system and is deployed by pulling back the outer sheath at the T-Connector while immobilizing the inner shaft. The stent remains in the vessel as a permanent implant.

The Astron stent is available with fully expanded stent diameters of 7, 8, 9 and 10 mm and stent lengths of 30, 40, 60 and 80 mm. 

Astron self-expanding nitinol stent systems have been market released outside the United States since October 2003. The FDA said the Astron stent system has not been subject to any Field Safety Corrective Action or recall since introduction.

For more information www.biotronik.com

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Overlay Init