Tag: Surmodics

Surmodics Announces Successful First Patient Use of Sublime™ Radial Access Microcatheter Designed for the Periphery

Sublime Radial Access Platform to include the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health […]

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 […]

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 […]

Differentiated Capabilities of Surmodics’ Crystalline Drug Release Platform for Sirolimus-Coated Balloons Presented at ISET Conference

Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon January 19, 2023 08:30 AM Eastern Standard Time EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of […]

Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium

Sundance™ Sirolimus Drug-Coated Balloon exhibits excellent safety profile Primary patency maintained at 12 months in 80% of per protocol analysis population EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 12-month data […]

24-Month Data from Surmodics’ TRANSCEND Trial Presented at VIVA 2022 Conference

SurVeil™ Drug Coated Balloon (DCB) demonstrates sustained durability of safety, efficacy endpoints SurVeil™ DCB non-inferior to market leading IN.PACT® Admiral® DCB at a substantially lower drug dose 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 24-month […]

Surmodics Announces New Credit Facilities Providing up to $125 Million in Financing

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 that it has entered into a new, five-year credit agreement with MidCap Financial (“MidCap”), comprised of up to $100 million in term loans and a $25 […]

6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe

Sundance™ Sirolimus DCB demonstrates lowest binary restenosis at 6 months compared to relevant BTK clinical trials Excellent safety profile observed with no major amputations and low rates of MAE 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, […]

6-Month Data from the Surmodics SWING First-in-Human Study to be Presented at AMP Europe

35-subject trial evaluating safety, performance of Surmodics’ Sundance™ Sirolimus 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, announced today that Professor Ramon Varcoe will present 6-month data from the SWING Trial, a first-in-human study of […]