Tag: Surmodics

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

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

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

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

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

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

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...
Surmodics

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

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...
Surmodics

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

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...