Patients with critical limb ischemia experienced two-and-a-half-fold higher amputation rates when physicians used paclitaxel-eluting IN.PACT Amphirion drug-eluting balloons as opposed to percutaneous transluminal angiography. Although the trial met its noninferiority threshold, findings resulted in the manufacturer pulling the device from the market.

Watchman’s future became even murkier with the latest vote from an FDA advisory panel. Panelists voted unanimously in favor of the device for safety but split on efficacy.

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.

Non-steroidal anti-inflammatory drugs (NSAIDs) may be good for what hurts, but they also could be setting patients up for pulmonary embolism. Venous thromboembolism (VTE) risk was increased in patients on NSAIDs, according to a study published Sept. 29 in Rheumatology.

Janssen Pharmaceuticals plans to make a starter pack of the anticoagulant rivaroxaban available in pharmacies in October. The starter pack is designed to simplify dosing for patients at risk of deep vein thrombosis or pulmonary embolism during the first 30 days of treatment.

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).

Unfractionated heparin-vitamin K antagonist combination was found to be the least effective of venous thromboembolism treatments in a meta-analysis published online Sept. 17 in JAMA while some novel oral anticoagulants carried lower bleeding risks.

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.