Medtronic ($MDT) yesterday announced FDA 510(k) clearance of the NC Euphora Noncompliant Balloon Dilatation Catheter to encourage stent apposition to the artery wall.
Medtronic touts the product's deliverability, low lesion entry profile, durability, low growth profile and environmentally friendly packaging. The NC Euphora is one of 12 new interventional products planned over the next two years, Medtronic said in a company statement.
Stent underexpansion is associated with restenosis (artery renarrowing) and the formation of blood clots (stent thrombosis), according to Medtronic. Postdilation is sometimes performed after the insertion of the stent to ensure full expansion.
"The cath lab team recognizes that balloon catheters are a key component of the procedure, and availability of a device that optimizes stent deployment presents a key opportunity that we have to achieve procedural success," said Chad Dupree of Atlanta's Piedmont Heart Institute in a statement.
The NC Euphora received a CE mark for use in Europe in May.
In addition, Medtronic unveiled the Cath Lab Connect to increase educational outreach and networking among clinicians and technicians who work in a catheterization lab, where heart imaging and cardiology procedures using catheters are performed.
The cath lab is part of Medtronic's increased focus on services. Last year it announced contracts to manage the cath labs of two U.K. hospitals, and it runs virtual cath labs in Europe where physicians can operate on mannequins and practice using Medtronic devices in simulated conditions.
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