Tag: stent graft
Gore’s Viabahn VBX stent graft receives US FDA approval
Gore has announced recent US Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft).
"Our team...
Medtronic announces first enrolment in head-to-head global randomised trial evaluating durability...
Medtronic has announced the first patient enrolment in the ADVANCE trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the...
Endologix submits premarket approval application to FDA for Detour system
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration...
Hyperflex balloon catheter by Endovastec receives marketing approval in Japan
Shanghai MicroPort Endovascular MedTech (Endovastec) recently announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the Hyperflex...
“Very encouraging” 12-month data from WRAPSODY FIRST study presented at CIRSE...
Twelve-month results from a first-in-human study of the Wrapsody cell-impermeable endoprosthesis (Merit Medical Systems) for the treatment of access circuit stenosis in haemodialysis patients...
TORUS SFA stent graft pivotal study granted unconditional IDE approval
PQ Bypass recently announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel...
CryoLife enters into strategic distribution agreement with Endospan
According to a press release, Cryolife has entered into strategic distribution and credit facility agreements with Endospan. Under the terms of the agreement, CryoLife...
INCRAFT device deemed safe and effective according to its five-year results
Five-year data from the INSPIRATION US investigational device exception (IDE) pivotal trial confirms favourable safety and effectiveness of the INCRAFT device. Presenting the trial...
Tackling the uncommon, but devastating, complication of infection after EVAR
Rachel Bell (Guy’s and St Thomas’ Hospital, London, UK) describes a variety of specialist surgical options to treat infection after endovascular aneurysm repair (EVAR),...
RelayBranch early feasibility study begins enrolment
The first two patients have been successfully enrolled in the RelayBranch Early Feasibility Study. This trial will assess the safety and efficacy of the...
Horizon stent graft receives CE mark
The Horizon stent graft system, developed to treat abdominal aortic aneurysms, has received CE mark. The stent graft system is produced by Endospan, a...
US FDA approves Gore Viabahn expandable stent graft for iliac artery...
The Gore Viabahn VBX balloon expandable endoprosthesis has received US Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found...
Five-year results confirm “long-term safety and durability” of Endologix Ovation system
Clinical data presented at the 2016 VEITH symposium (New York City, USA) of the global Ovation Pivotal Trial has revealed positive five-year safety and...
No type Ia or III endoleaks at three years with Incraft...
Preliminary results from the INNOVATION study indicate that the device is not associated with any type Ia or type III endoleaks at three years for patients undergoing EVAR. Incraft shows a freedom from sac increase rate of 95.6%.
