Peripheral Artery Disease

Bendit Technologies announced it received FDA 510(k) clearance for its steerable microcatheter platform for treatment in the neurologic, peripheral and coronary vasculature.

The Society for Cardiovascular Angiography and Interventions published its recommendations for percutaneous placement of large-bore arterial sheaths and devices specifically via transaxillary arterial access.

Transit Scientific announced the FDA cleared its support catheter platform for coronary use.

Comorbid peripheral artery disease is a significant risk factor for adverse events for patients with acute MI with cardiogenic shock, including worse limb outcomes and poorer short- and long-term survival compared with those without PAD.

Cordis announced the FDA has approved its self-expanding vascular stent designed for transradial peripheral procedures in the iliac and superficial femoral arteries.

Arrow International issued a recall of its percutaneous thrombolytic device due to risk for tip damage during use and subsequent detachment from the basket.

In a real-world registry of patients with peripheral artery disease, 5-year outcomes of a drug-coated balloon were positive regardless of sex and diabetes status, researchers reported at the International Symposium on Endovascular Therapy.

In a patient-level meta-analysis of two pivotal trials of a paclitaxel-coated balloon, the paclitaxel-coated balloon was not associated with elevated risk for mortality in patients with peripheral artery disease at 5 years.

Contemporary data suggest paclitaxel-coated devices do not elevate mortality risk in patients with peripheral artery disease, and they should be used more routinely, according to a speaker.

Medtronic is recalling its HawkOne Directional Atherectomy System due to risk for the tip of the catheter becoming damaged during use, which may include the catheter tip breaking off or separating, according to an FDA press release.