Tag: atherectomy

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 the natural history of...

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...