Delamination Risk Provokes Covidien Recall of PTFE Coated Vascular Products

Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

FDA Clearance for Ablative Solutions Peregrine System™ Infusion Catheter

Ablative Solutions, Inc., has received U.S. FDA 510(k) clearance for its Peregrine System™ Infusion Catheter. The system uses a unique, patent-pending technology to deliver diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels.

Mynx Ace™ Vascular Closure Device Leaves No Implant Behind

AccessClosure Inc., has commercially launched its Mynx Ace Vascular Closure Device at ACC 2014. The company says the device is a safe and secure vascular closure product that provides consistent results with a new, easy-to-use deployment system to seal femoral artery access sites.

FDA Approves Abbott’s Supera® Stent to Treat People with Peripheral Artery Disease

Abbott’s Supera® Peripheral Stent System has received U.S. FDA approval to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12 to 20 percent of Americans age 65 or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.

FDA Clears Cardiovascular Systems’ Low Profile, 60cm Diamondback Orbital Atherectomy Devices

CSI’s new Diamondback Peripheral 60cm systems are available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown. Each device offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use.

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