Surmodics has received FDA 510(k) clearance for its Sublime guide sheath.
The Sublime sheath is designed to resist kinking while maximizing strength with a low profile. It is available in 5Fr and 6Fr diameters and 120 cm and 150 cm lengths. The Sublime sheath is also coated in a Serene hydrophilic coating to create a lubricious surface. It is also preloaded with a dilator with a hemostasis valve and a side arm for flushing. The dilators are available in sizes to accommodate .018 in. and .035 in. guide wires.
“Surmodics continues to make progress int he development of clinically important and innovative technologies,” Gary Maharaj, president and CEO of Surmodics, said in a press release. “Our Sublime guide sheath will set a new standard for performance and enable the delivery of lower extremity interventions from the radial artery.”
The Sublime guide sheath can help introduce therapeutic or diagnostic devices into the vasculature, not including coronary and neuro vasculature. The radial access offers reduced puncture site bleeding complications, earlier ambulation, reduced hospital says and lower healthcare costs, according to the company.