Tag: SFA

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...

OUTBACK™ Elite Re-entry catheter highly effective at saving limbs in extreme...

Lorenzo Patrone (London, UK) shares with BLearning at CIRSE 2019 (7–11 September, Barcelona, Spain) the benefits of using the OUTBACK™ Elite Re-entry Catheter (Cordis,...

Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower...

Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease....

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...

Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...

LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment...

Medtronic added to its body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical outcomes...

Bard gets FDA premarket approval of the Lutonix 035 DCB for...

Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...

Biotronik BIOFLEX-1 trial demonstrates safety and efficacy of Pulsar-18 SFA stent

Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked...

LEG-DEB registry reports encouraging six-month interim analysis for LegFlow

Six-month interim analysis of the Legflow drug-eluting balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry indicates that “the use of a new generation...

SUPERFAST results show advantage of Supera for chronic total occlusions

New data from a propensity matched prospective study suggest the Supera stent (Abbott Vascular) delivers superior results when compared to older generation nitinol stents...

Enrolment completed in the MIMICS-2 study

Veryan Medical has announced completion of patient enrolment in the MIMICS-2 clinical study of its BioMimics 3D self-expanding stent system (BioMimics 3D), which features...

Akesys and Elixir announce first human implant of the Prava bioresorbable...

Akesys Medical has announced their first clinical trial and successful implant of the Prava sirolimus-eluting bioresorbable peripheral scaffold system for the treatment of blockage...

Shockwave Medical Lithoplasty system is cleared by the FDA

Shockwave Medica has announced clearance from the US Food and Drug Administration (FDA) of the Lithoplasty system for the treatment of calcified plaque in...

First patient enrolled in the MIMICS-3D registry

Veryan Medical has announced that the first patient has been enrolled into the company-sponsored MIMICS-3D registry by Michael Lichtenberg, Arnsberg, Germany. MIMICS-3D is a...

Gore Tigris vascular stent gains FDA approval for treatment of peripheral...

Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design....

REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy...

Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for...

Promising findings for novel drug-eluting peripheral stent

A new animal study, presented at EuroPCR (17–20 May, Paris), indicates that a novel, fluoropolymer-coated, self-expanding, paclitaxel-eluting peripheral stent (Eluvia, Boston Scientific) is associated...