Tag: SurVeil

Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon

Surmodics to receive $27 million milestone payment from Abbott EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB). The SurVeil DCB may now be […]

Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon

Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has received formal feedback from the […]

Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for 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 to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB). In the letter, […]

12-Month Data from Surmodics’ TRANSCEND Trial Presented at LINC 2021 Event

SurVeil™ Drug Coated Balloon (DCB) demonstrates non-inferior safety and efficacy, while using a substantially lower drug dose, vs. the IN.PACT® Admiral® DCB for treatment of femoropopliteal lesions. EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 12-month data from its TRANSCEND […]

Surmodics Completes Enrollment in Pivotal TRANSCEND Clinical Trial

Study designed to evaluate safety, efficacy of the company’s next-generation SurVeil™ drug-coated balloon Company Raises 2019 Revenue and EPS Guidance EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has completed enrollment in TRANSCEND, its pivotal clinical trial for […]