Tag: Surmodics

Surmodics Reports First Quarter Fiscal 2018 Results, Updates Fiscal 2018 Guidance

Feb. 8, 2018 12:30 UTC EDEN PRAIRIE, Minn.–(BUSINESS WIRE)– SurModics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced results for its fiscal 2018 first quarter, ended December 31, 2017, and updated financial outlook for fiscal 2018. “We are making steady […]

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 […]