Tag: Surmodics

Surmodics provides regulatory update related to FDA premarket approval application for...

Surmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the...

SWING trial 12-month data: Novel sirolimus DCB shows ‘great promise’ in...

The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI population,” and has a primary...

SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND

In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated "excellent efficacy and safety" out to 24-month follow-up. This is according to...

Surmodics announces successful first patient use of Pounce thrombectomy system

Surmodics has announced that J. Michael Bacharach, MD, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls,...

Surmodics builds thrombectomy portfolio with acquisition of Vetex Medical

Surmodics recently announced that it has acquired privately-held Vetex Medical Limited, expanding the company's thrombectomy portfolio with a second Food and Drug Administration (FDA) 510(k)-cleared...

Surmodics announces first patient uses of two Sublime radial access platform...

Surmodics recently announced the successful first uses in patients for two devices within its Sublime radial access platform: the Sublime radial access guide sheath and...