Tag: Surmodics

Pounce LP

Surmodics announces successful early clinical use of Pounce LP thrombectomy system

Surmodics has announced successful early clinical use of the company’s Pounce LP (low-profile) thrombectomy system. The Pounce LP system, which received US Food and Drug...
Pounce LP

Surmodics announces successful early clinical use of Pounce LP thrombectomy system

Surmodics has announced successful early clinical use of the company’s Pounce LP (low-profile) thrombectomy system. The Pounce LP system, which received US Food and Drug...

Surmodics launches Preside hydrophilic coatings for neurovascular, coronary and peripheral applications

Surmodics has announced the commercial launch of its most advanced hydrophilic medical device coating technology, the Preside hydrophilic coatings. As per a company press release,...
TOP 10

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

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

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

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...
Surmodics

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...
Surmodics

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

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

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...
Surmodics

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

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 pounce

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...
balloon catheter

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 pounce

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 pounce

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 pounce

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 pounce

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...