Tag: Surmodics
Interventional News’ top 10 most popular stories of June 2023
Interventional News’ most popular stories from June included a letter from the joint editor-in-chief on the current state of interventional radiology (IR) practice and...
Advance Serenity PTA balloon now available in more sizes and locations
As announced at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA), the Advance Serenity hydrophilic percutaneous...
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 receives 510(k) clearance for Pounce LP thrombectomy system
Surmodics announced in a press release that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low...
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...
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...
Six-month SWING trial data show promise for Sundance DCB
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 announces first patient use 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...
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...
