News | Guidewires | October 11, 2019

FDA Issues Final Guidances on Guidewires, Intravascular Catheters and Delivery Systems

Pair of guidances address performance testing and labeling considerations for cath lab devices with lubricious coatings as well as guidewires

FDA Issues Final Guidances on Guidewires, Intravascular Catheters and Delivery Systems

October 11, 2019 — The U.S. Food and Drug Administration (FDA) issued two final guidances for the performance testing and labeling of cardiac catheterization lab devices.  

Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings - Labeling Considerations addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The guidance is intended to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. 

The FDA said these labeling recommendations should be considered for inclusion as current device labeling is updated, and for labeling included as part of future premarket submissions for devices with lubricious coatings.

Read the full guidance here.

Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling provides recommendations for content, performance testing and labeling to include in a premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature and neurovasculature.

Read the article “Recent Advances in Interventional Guidewire Technology“  

The FDA said these recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions.

Read the full guidance here.

For more information: www.fda.gov

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...