Tag: SurVeil
Surmodics receives FDA approval for the SurVeil drug-coated balloon
Surmodics has announced the receipt of US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).
A company press release notes that...
Surmodics provides regulatory update related to its FDA premarket approval application...
Surmodics recently announced it has received a letter from the US Food and Drug Administration (FDA) related to its premarket approval (PMA) application for...
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...
LINC 2021: Head-to-head trials take centre stage in drug-eluting technology late-breaking...
Data from two head-to-head trials on drug-eluting technologies in femoral artery treatment were presented during a late-breaking session at LINC 2021 (The Leipzig Interventional...
Surmodics provides update regarding TRANSCEND clinical trial
Surmodics has announced the company has now resumed patient enrolment into its TRANSCEND clinical trial, and is nearly 75% of the way to its...
Surmodics partners with Abbott to develop their next-generation DCB
Abbott and Surmodics have announced an agreement whereby Abbott will have exclusive worldwide commercialisation rights for Surmodics' SurVeil drug-coated balloon (DCB) to treat the superficial...
First patient enrolled in TRANSCEND trial for SurVeil DCB
Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate...
Encouraging 100% primary patency and improved quality-of-life scores at six months...
Data from the Surmodics PREVEIL early feasibility study of the company’s SurVeil drug-coated balloon (DCB) was shared in a late-breaking clinical trial presentation at...
Surmodics receives IDE approval to initiate SurVeil drug-coated balloon pivotal trial
Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the...
