Tag: Surmodics
First patient enrolled in PROWL registry study using Pounce thrombectomy system
Surmodics has announced enrolment of the first patient in PROWL, the Pounce thrombectomy system retrospective registry. PROWL is an open-label, retrospective, multicentre US registry...
Surmodics announces successful first patient use of Sublime radial access microcatheter...
Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were...
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...
Vascular News’ top 10 most popular stories of November 2022
November's top 10 includes the first results from BEST-CLI, as well as new data presented at this year's Vascular Interventional Advances (VIVA; 31 October–3...
SWING trial 12-month data: Novel sirolimus DCB shows “great promise” in...
The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI population,” and has a primary...
Vascular News’ top 10 most popular stories of October 2022
Five-year outcomes from the randomised SPACE-2 trial on carotid artery stenosis, an interview with Joseph S Coselli, and a report on the "significant" increase...
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...
Six-month data from the Surmodics SWING BTK first-in-human trial presented at...
Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention...
Pounce thrombectomy system first-in-human data show 100% technical success in early...
Surmodics has announced that its Pounce thrombectomy system achieved 100% technical success in 20 first-in-human (FIH) procedures. The FIH data were presented by Gary...
Surmodics announces successful first patient use of Pounce thrombectomy system
Surmodics has announced that J. Michael Bacharach, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, USA,...
Surmodics builds thrombectomy portfolio with acquisition of Vetex Medical
Surmodics recently announced that it has acquired privately-held Vetex Medical Limited. The Galway, Ireland-based medical device developer and manufacturer has focused exclusively on venous...
Vascular News’ top 10 most popular stories of April 2021
Highlights from the Charing Cross (CX) 2021 Digital Edition (19–22 April, online)—including the potential of Philips’ Fiber Optic RealShape (FORS) technology to reduce radiation...
Surmodics announces first patient uses of two Sublime radial access platform...
Surmodics recently announced the successful first uses in patients for two devices within its Sublime radial access platform: the Sublime radial access guide sheath...
Six-month data from Surmodics Avess AV fistula DCB first-in-human study presented...
Surmodics recently announced that six-month data from the AVESS first-in-human (FIH) study of the company’s Avess arteriovenous fistula (AVF) drug-coated balloon (DCB) was shared...
Surmodics’ Pounce thrombus retrieval system gains FDA 510(k) clearance
Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system.
The company describes the Pounce system...
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...
