Tag: atherectomy
New data add to body of research demonstrating safety and effectiveness...
Results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions have just been released as late-breaking data presentations at VIVA 2024...
AngioDynamics announces CE mark approval in Europe for the Auryon system
AngioDynamics today announced European CE mark approval of the Auryon atherectomy system, designed for the treatment of peripheral arterial disease (PAD), including chronic limb-threatening...
Claudication: Long-term Medicare study highlights “critical” need for value-based care
A newly published US Medicare cohort study illuminates trends and factors associated with peripheral vascular interventions (PVIs)—including a sharp rise in the use of...
AngioDynamics announces US FDA 510(k) clearance of Auryon XL radial access...
AngioDynamics today announced that the US Food and Drug Administration (FDA) has cleared the Auryon XL catheter, a 225cm radial access catheter, for use with...
Mainstream media dig deeper into atherectomy use in the USA, SVS...
Further reports on the use of atherectomy in the USA this week appeared in ProPublica. The nonprofit investigative news outlet shared three articles in...
Cardio Flow announces US FDA 510(k) clearance for its FreedomFlow orbital...
Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform.
The company...
Patients with claudication receive more “aggressive” surgical management in high-competition regions,...
Demonstrating the “susceptibility” of care delivery to regional market competition, M Libby Weaver (University of Virginia, Charlottesville, USA) presented the case that intermittent claudication...
Cardiovascular Systems enrols first patient in Japan for KAIZEN clinical study
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment...
Vascular News’ top 10 most popular stories of October 2022
Five-year outcomes from the randomised SPACE-2 trial on carotid artery stenosis, an interview with Joseph S Coselli, and a report on the "significant" increase...
“Significant” increase in atherectomy use in the USA largely driven by...
In the USA, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of...
Vascular News 96 – November 2022 US Edition
In this issue:
ESVS publishes "pioneering" clinical practice guidelines on radiation safety
What to expect from CX Aortic Vienna 2022
In profile: Markus Steinbauer (Regensburg,...
Vascular News 96 – November 2022 OUS Edition
In this issue:
ESVS publishes "pioneering" clinical practice guidelines on radiation safety
What to expect from CX Aortic Vienna 2022
In profile: Markus Steinbauer (Regensburg,...
AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system
AngioDynamics recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system...
Northeast Scientific receives 510(k) for Turbo-Elite laser atherectomy catheter reprocessing
Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug...
Medtronic recalls HawkOne directional atherectomy system due to risk of tip...
According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system.
The FDA has identified the recall as a...
Avinger announces FDA clearance of Pantheris for the treatment of in-stent...
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...
BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy...
BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.
The...
First patient treated with Cardiovascular Systems’ ViperCross peripheral support catheter
Cardiovascular Systems recently announced that the first patient has been successfully treated with its ViperCross peripheral support catheter.
Billy J Kim (The Surgical Clinic, Nashville,...
Biotronik expands range of peripheral introducer sheaths
Biotronik has announced the expansion of the Fortress reinforced introducer sheath line, which is now available in 7- and 8Fr-compatible sizes in the USA...
Directional atherectomy prior to IN.PACT DCB effective out to one year,...
A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal...
Straub Medical announces first patient treated in USA with Rotarex S atherectomy device
Straub Medical (United States), the US direct-sales subsidiary of Straub Medical AG (Switzerland), has announced the launch and first intervention performed with the Rotarex S atherectomy device designed for...
Ra Medical Systems announces enrolment of first patient in pivotal atherectomy...
Ra Medical Systems has announced enrolment of the first patient in its pivotal study to evaluate the safety and effectiveness of the DABRA excimer...
Cardiovascular Systems introduces peripheral orbital atherectomy system with GlideAssist in Europe
Cardiovascular Systems announced today that the first patient in Europe has been treated with its Stealth 360 peripheral orbital atherectomy system (OAS) 1.25mm Micro...
VIVA 2019: Revolution system meets primary and safety endpoints in REVEAL...
Findings from the REVEAL study confirm a favourable safety and effectiveness profile through six months for the Revolution peripheral atherectomy system from Rex Medical....
Rex Medical receives 510k clearance for Revolution Peripheral Atherectomy System
Rex Medical recently announced that it has received 510k clearance from the US Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
Regulatory...
First European patients treated with Peripheral Orbital atherectomy system
The first patients in Germany have been treated with the Stealth 360 Peripheral Orbital Atherectomy System (OAS; Cardiovascular Systems Inc). The German cases represent...
Consider intravascular lithotripsy when treating calcified femoropopliteal arteries
Treating severely calcified arteries by endovascular means is still a challenge, although atherectomy, stents and lithotripsy are all techniques that are employed. Lithotripsy (also...
IVUS outperforms angiography in dissection detection post-PTA
The iDissection Classification trial results published in the Journal of Invasive Cardiology have shown that with the use of intravascular ultrasound (IVUS) investigators were...
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...
LIBERTY 360 18-month outcomes presented at CRT
Cardiovascular Systems Inc (CSI) presented 18-month outcomes from its LIBERTY 360 study at the Cardiovascular Research Technologies (CRT; 3-6 March, Washington, DC, USA). The...
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...
First patient enrolled in IDE study of the Pantheris system for...
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...
Lesion preparation using Diamondback 360 orbital atherectomy enhances paclitaxel distribution in...
CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, has announced that its scientists have published data...
Gardia Medical demonstrates enhanced safety in lower extremity interventions
Gardia Medical has announced that, according to the independent Clinical Events Committee (CEC), the company has successfully met the primary endpoint in its WISE-LE...
RD Global-Invamed receives CE mark to market Extender DCB and Temren...
RD Global-Invamed has announced it has received CE marking to market the Extender drug-coated balloon (DCB) and Temren atherectomy with CTO catheter for treating...
Outpatient atherectomy outcomes may be “worse than natural history of disease”
Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history...
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...
Cardiovascular Systems signs distribution agreement with Medikit for Japan
Cardiovascular Systems has signed an exclusive distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan.
According to...
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...
Medtronic receives FDA clearance of new lower profile HawkOne 6F directional...
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating...
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...
Ra Medical Systems receives European approval for DABRA atherectomy and Pharos...
Ra Medical Systems has received CE mark approval for both the DABRA atherectomy system with catheter and the Pharos excimer laser to treat psoriasis,...
Positive late-breaking DANCE clinical trial data presented at VIVA 2016
Christopher Owens, associate professor of Surgery in the Division of Vascular and Endovascular Surgery at the University of California, San Francisco (UCSF), USA, has...
Cardiovascular Systems releases 30-day results from LIBERTY 360° study
Cardiovascular Systems has released procedural and 30-day results from its LIBERTY 360° study in a late-breaking presentation at the 2016 Amputation Prevention Symposium (AMP;...
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...
