Tag: Surmodics
Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX...
Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous...
Advance Serenity hydrophilic PTA balloon catheter now available in the USA
Cook Medical recently announced that the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The...
Surmodics receives CE mark for its SurVeil drug-coated balloon
Surmodics recently announced it has received CE mark certification in the European Union for its SurVeil drug-coated balloon (DCB).
“I am excited about the potential...
New balloon catheter available in USA for use in the treatment...
The Advance Serenity Hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The catheter is manufactured by Surmodics...
Surmodics completes enrolment in pivotal TRANSCEND clinical trial
According to a press release, Surmodics has completed enrolment in TRANSCEND, its pivotal clinical trial for the SurVeil drug-coated balloon (DCB).
“TRANSCEND is a rigorous...
Surmodics Sublime guide sheath receives FDA 510(k) approval
Surmodics has announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime guide sheath.
The highly flexible, proprietary Xtreme braid-reinforced...
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...
12-Month data from PREVEIL study of SurVeil DCB presented at VIVA
Data from the PREVEIL early feasibility study of the SurVeil drug-coated balloon (DCB, Surmodics) were shared in a late-breaking clinical trial presentation at the...
Surmodics gets US FDA 510(K) clearance for Telemark support microcatheter
Surmodics has announced receiving US FDA 510(k) clearance for its Telemark 0.014” coronary and peripheral support microcatheter. The company is making this product available...