Medical Device News

Surmodics Sublime Guide Sheath Receives FDA 510(k) Approval

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime guide sheath.

The highly flexible, proprietary Xtreme® braid-reinforced Sublime sheath is designed to resist kinking and maximize strength while retaining a low profile. The sheath will be available in 5Fr and 6Fr diameters, and 120cm and 150cm lengths. The entire working length of the guide sheath is Serene® hydrophilic coated to provide a lubricious surface. It is preloaded with a dilator and has a hemostasis valve with side arm for flushing. The dilators are available with .018” and .035” guide wire compatibility.

Surmodics continues to make progress in the development of clinically important and innovative technologies,” said Gary Maharaj, Surmodics President and CEO. “Our Sublime guide sheath will set a new standard for performance and enable the delivery of lower extremity interventions from the radial artery.”

Radial artery access has been widely adopted for use in coronary procedures where devices have been developed to accommodate that need. The Sublime guide sheath is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding the coronary and neuro vasculature. Radial access offers many benefits relative to femoral access including reduced puncture site bleeding complications, earlier ambulation, reduced length of hospital stay, and lower healthcare costs.1

The development of the Surmodics Sublime guide sheath is a step forward in the Company’s strategy to be a provider of whole-product vascular solutions, including a family of radial access products. Surmodics has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter and specialty catheter solutions.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.

Valencia Technologies Announces CMS Publication of 2025 Medicare Proposed Rule for eCoin® Procedure

Ann Decker, VP of Reimbursement for Valencia Technologies, stated, "The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond.