FDA OKs Medtronic bare-metal stent with more flexible design for improved implantation

Medtronic gets FDA appoval for new stent

MINNEAPOLIS — Medtronic Inc., the world’s largest medical device maker, said Monday it has received U.S. approval for a new artery-bracing stent that may be easier for surgeons to implant.

The Food and Drug Administration approved the company’s Integrity bare metal stent, which features a new, more flexible construction.

Stents are mesh-metal tubes designed to hold arteries open after they have been cleared of potentially deadly plaque. The devices are usually threaded into a small incision in the groin and then up into the patient’s artery. Once the catheter reaches the blockage, a balloon inflates, crushing the plaque and squeezing the stent into place.

Medtronic said its new stent differs from older models because it is made from one continuous piece of metal. The company’s previous metal stent, Driver, was made from a series of rings fused together.

Medtronic markets both bare metal and drug-coated stents. The drug coatings are designed to prevent scar tissue from growing back through the mesh and reclogging the patient’s artery.

A company spokesman said the approval of Integrity will allow Medtronic to explore drug-filled stent technology, versus currently available drug-coated stents. Some research suggests the polymers used to coat stents with drugs can lead to blood clots.

Medtronic rose 22 cents Monday to $33.52.