FDA Clears Surmodics’ Sublime Guide Sheath

Surmodics Inc., a provider of medical device and in vitro diagnostic technologies to the healthcare 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 120 and 150 cm 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.
 
Reference
¹ Mason P, Shah B, Tamis-Holland JE, et al. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angioplasty and Intervention in Acute Coronary Syndrome. A Scientific Statement from the American Heart Association. Circ Cardiovasc Interv. 2018;11:e000035,p 1-21.