Feature | October 02, 2013

FDA Offers Draft of Updated Engineering Tests for Stents, Delivery Systems

stents cath lab FDA update guidance delivery system

October 2, 2013 — The U.S. Food and Drug Administration (FDA) released a draft of its proposed updates for the non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. It is designed to provide draft guidance for industry and FDA staff.

FDA has developed a guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices.  While FDA is in the process of making more substantial updates to the Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance, it is issuing a “short guidance update” on select sections in order to notify the industry in a timely manner of its revised recommendations. 

Section III of the guidance provides cross-reference and updates to the related sections of the existing guidance.  Following the close of the comment period on this guidance, FDA intends to consider the comments received, revise this guidance as appropriate and publish it in final.  Simultaneously, FDA will issue an update to the existing guidance to cross-reference where this selected updates guidance supersedes the existing recommendations.  Subsequently, FDA will incorporate the elements of this final guidance into an anticipated revision of the entire Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance.

Some updates the draft includes deal with material characterization, material composition, and biocompatibility.  The guidance can be found on FDA’s website.

For more information: www.fda.gov

Related Content

ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Medtronic, CE Mark, Resolute Onyx DES, drug-eluting stent, expanded sizes and indications
News | Stents Drug Eluting| February 02, 2016
Medtronic plc announced the recent CE Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES,...
TOBA-BTK study, six-month results, LINC 2016, Tack Endovascular System
News | Peripheral Arterial Disease (PAD)| January 29, 2016
Intact Vascular Inc. announced that positive six-month results from its Tack Optimized Balloon Angioplasty – Below-the-...
Toshiba, CT-angiography, hybrid OR

Toshiba recently introduced a new line of combined CT and angiography systems, allowing true CT imaging on demand in the interventional lab.

Feature | Angiography| January 27, 2016 | Dave Fornell
All of the major vendors in the United States introduced new systems and technologies in the past few years to reduce...
Technology | Ultrasound Intra-cardiac Echo (ICE)| January 26, 2016
Conavi Medical Inc. (formerly Colibri Technologies Inc.) has received U.S. Food and Drug Administration (FDA) 510(k)...
medical device excise tax, two-year suspension, U.S. market, GlobalData analyst
News | Business| January 25, 2016
The suspension of the medical device excise tax will have positive consequences for the U.S. medical device market over...
Abbott, Absorb, BVS, FDA review, FDA panel

The Abbott Absorb BVS.

News | Cath Lab| January 20, 2016 | Dave Fornell
The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel is set to review data and offer...
Overlay Init