Vascular & Endovascular

This channel includes news on non-coronary vascular disease and therapies. These include peripheral artery disease (PAD), abdominal and thoracic aortic aneurysm (AAA and TAA), aortic dissection, pulmonary embolism (PE), critical limb ischemia (CLI), carotid artery and stroke interventions, venous interventions, deep vein thrombosis (DVT), and interventional radiology therapies. The focus on most of these therapies is minimally invasive, catheter-based procedures performed in a cath lab.

Covidien’s HawkOne Directional Atherectomy System receives FDA 510(K) clearance for the treatment of peripheral arterial disease

Covidien plc (NYSE: COV) today announced U.S. Food and Drug Administration 510(k) clearance for the HawkOne™ directional atherectomy system. The latest addition to Covidien’s directional atherectomy portfolio, the HawkOne system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD).

November 4, 2014

Cardiovascular Systems receives CE mark for Stealth 360 Peripheral Orbital Atherectomy System

Cardiovascular Systems, Inc. today announced that it has received CE (Conformité Européenne) Mark for its Stealth 360º Orbital Atherectomy System (OAS). Stealth 360 is a percutaneous OAS that is indicated to treat patients who suffer from peripheral arterial disease (PAD).

November 4, 2014

Essential Medical, Inc. announces CE mark approval for new vascular closure device, X-Seal

Essential Medical, Inc., a privately held medical device company, announced today that it has received CE mark approval for X-Seal, a new vascular closure device with superior handling and closure features. 

October 27, 2014

Northside continues Southeast leadership in exclusive robotics surgeries

Northside Hospital Healthcare System continues to lead the Southeast in state-of-the-art surgical services with the introduction of three advanced robotic surgery technologies: The Magellan Robotic System, the da Vinci Xi Surgical System and the MAKOplasty surgical arm.

October 21, 2014

Accreditation for Cardiovascular Excellence (ACE) selected by CMS to accredit CREST-2 Registry Clinical Sites

The Centers for Medicare & Medicaid Services (CMS) has determined that clinical sites that wish to participate in the newly announced CREST-2 carotid artery stenting (CAS) registry must receive accreditation. Accreditation for Cardiovascular Excellence (ACE) is a designated organization to provide these reviews. The objective of the CREST-2 Registry is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial. Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with CAS performed by experienced and skilled interventionists.

October 2, 2014

InspireMD announces positive results from CGuard CARENET trial with 0% MACE reported at 30 days

InspireMD, Inc., a leader in embolic protection systems (“EPS”), today announced positive results from the CARENET (CARotid Embolic protection study using microNET) Trial for its CGuardTM EPS. This trial demonstrates that the MicroNetTM covered CGuardmay offer important clinical benefits for patients undergoing carotid artery stenting (CAS).

September 17, 2014

Medtronic drug-coated balloon shows strong clinical and economic benefit in treatment of peripheral artery disease

Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic, Inc. augments an already robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee.

September 16, 2014

EXCITE ISR proves superiority in safety, efficacy of laser atherectomy with PTA vs. PTA alone; Data presented at TCT 2014

The Spectranetics Corporation today announced that Eric Dippel, MD, at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, presented findings from the EXCITE ISR clinical trial proving Spectranetics' laser atherectomy devices, used with PTA (also known as balloon angioplasty), are clinically superior to PTA alone in both safety and efficacy, triggering a new standard in cardiovascular care. 

September 16, 2014

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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