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...
Cook Medical and Surmodics reach distribution agreement for two new vascular...
Cook Medical and Surmodics have announced an agreement in which Cook Medical will distribute two new Surmodics products, hydrophilic percutaneous transluminal angioplasty (PTA) balloon...
Sundance sirolimus-coated balloon catheter granted FDA breakthrough device designation
Surmodics has announced that the US Food and Drug Administration (FDA) has designated its Sundance sirolimus-coated balloon catheter as a breakthrough device under the...
Surmodics completes enrolment in pivotal TRANSCEND clinical trial
Surmodics has completed enrolment in TRANSCEND, its pivotal clinical trial for the SurVeil drug-coated balloon (DCB).
“TRANSCEND is a rigorous level one, randomised controlled trial...
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 acquires thrombectomy technology assets from Embolitech
Surmodics, a provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has reached an agreement with Embolitech to...
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...
Surmodics announces global approvals of 0.014” low-profile PTA balloon dilation catheter
Surmodics has received US Food and Drug Administration (FDA) 510(k) and CE mark clearance for its 0.014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation...
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...
