Tag: Surmodics

FDA Green Lights Surmodics’ Telemark Coronary/Peripheral Support Microcatheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)– SurModics (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Telemark™ .014” coronary and peripheral support microcatheter. The Company is making this product available for U.S. distribution in the […]

Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in […]

Six-Month Data From The SurModics (SRDX) Surveil Drug-Coated Balloon Early Feasibility Study Presented At VIVA 2017

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced that data from the PREVEIL early feasibility study (EFS) of the company’s SurVeil®drug-coated balloon (DCB) was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances (VIVA) 2017 […]

SurModics (SRDX) Receives IDE Approval To Initiate Pivotal Trial Of The Surveil Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil™ drug-coated balloon (DCB). The randomized […]