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Avinger announces FDA clearance of Pantheris for the treatment of in-stent restenosis
Avinger recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new clinical indication for the...
Avinger receives FDA clearance of Pantheris SV device
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its Pantheris SV (small vessel) image-guided...
Avinger receives CE marking approval for Pantheris SV
Avinger, a developer of treatments for peripheral arterial disease (PAD), has announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product...
Avinger announces 510(k) filing of Pantheris Small Vessel device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the Company submitted a new 510(k) application to the US Food &...
Avinger’s next-generation Pantheris Lumivascular atherectomy system gets FDA clearance
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy...
First patients treated with Avinger’s next generation atherectomy device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...
Avinger announces positive two year data from pivotal VISION study of Lumivascular technology
Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were...
Avinger announces new FDA clearance for Lumivascular imaging console
Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this...
Avinger launches upgraded Lightbox imaging console
Avinger has announced the US launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images...
Avinger granted expanded US FDA indications for Pantheris image-guided atherectomy device
Avinger has received expanded indications from the US Food and Drug Administration (FDA) recognising the Pantheris lumivascular atherectomy system as a technology that can be...
Avinger announces FDA clearance and US launch of enhanced Pantheris system
Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for an enhanced version of its Pantheris lumivascular atherectomy system, an...
Avinger receives FDA 510(k) clearance for Pantheris
On 14 October 2015, Avinger announced that it has received 510(k) clearance from the FDA to commence US commercialisation of its Pantheris image-guided atherectomy system...
Avinger completes enrolment for VISION clinical trial
The study is designed to evaluate the safety and efficacy of the company's Pantheris system, a device that combines directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from lower extremity arteries.
Avinger enrols first patient in VISION trial
VISION is a global investigational device exemption (IDE) clinical trial, approved by the FDA, to evaluate Avinger's Pantheris catheter for the treatment of peripheral artery disease.
Avinger receives the CE mark for Pantheris lumectomy system
The Pantheris system combines directional atherectomy capabilities with real-time intravascular visualisation to remove plaque from blocked arteries. The system is designed to remove the blockage while avoiding the disruption of normal arterial wall structures.
Avinger announces primary investigators for upcoming VISION trial
VISION is a non-randomised global study designed to evaluate the safety and efficacy of Pantheris, an image-guided atherectomy device for use with real-time optical coherence tomography.
Avinger receives FDA clearance for Ocelot PIXL
Featuring smaller profile and longer length, the newest member of the Ocelot platform was cleared by the FDA one month after Avinger received clearance to commercially sell the Ocelot system.
Avinger enrols first European patient in CONNECT II global clinical trial
CONNECT II is a multicentre, non-randomised study designed to evaluate the safety and efficacy of Ocelot, Avinger's first therapeutic catheter to incorporate optical coherence tomography.
First patient enrolled in IDE study of the Pantheris system for in-stent restenosis
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...
In the spotlight: Atherectomy
The removal of plaque from peripheral arterial lesions is often needed when preparing vessels for adjunct therapies such as drug-coated balloons and drug-eluting stents....
Interim six-month VISION trial results presented at TCT
Avinger announced on 13 October 2015 interim six-month results for its VISION clinical trial. VISION is designed to evaluate the safety and effectiveness of...
Ocelot System is FDA cleared
FDA approval was supported with results from the CONNECT II global clinical trial in which the Ocelot System demonstrated a chronic total occlusion crossing success of 97% with 98% freedom from major adverse events.
CONNECT II clinical trial results for Ocelot CTO catheter to be presented at VIVA
CONNECT II is a global clinical study that evaluated the safety and efficacy of Ocelot, a chronic total occlusion (CTO) crossing catheter used in the treatment of patients with peripheral arterial disease.
CONNECT II clinical trial completes enrolment
Avinger has announced that it has successfully completed enrolment in its CONNECT II global clinical trial. A study focused on treatment of peripheral artery disease.
First US peripheral artery disease patient enrolled in CONNECT II trial
The CONNECT II global clinical trial is designed to evaluate the safety and efficacy of Ocelot (Avinger), the first-ever chronic total occlusion crossing catheter to use real-time intravascular optical coherence tomography imaging technology.
Two live Ocelot cases to be performed at LINC in Germany
Ocelot (Avinger) is the first real-time optical coherence guided crossing catheter for chronic total occlusions in the peripheral vascular system.
FDA approves the Wildcat catheter for crossing chronic total occlusions
Results from the CONNECT trial demonstrated that Wildcat (Avinger) was able to cross 89.3% (efficacy) of chronic total occlusions in peripheral artery disease that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile.
First patient enrolled in CONNECT clinical trial
Avinger has announced the enrolment of the first patient in the CONNECT (Chronic total occlusion crossing with the WildCat Catheter) clinical trial.
