FDA Approves New Heart Stents
Dec. 22, 1997
WASHINGTON (AP) _ The Food and Drug Administration approved the first in a new generation of heart stents Monday, a device that promises to keep diseased arteries from clogging up more easily than older versions.
Cordis Corp.'s Palmaz-Schatz Crown stent is more flexible than the nation's pioneer version, also called Palmaz-Schatz and made by Cordis parent company Johnson & Johnson.
That makes the new stent more feasible for smaller, harder-to-reach arteries, the FDA concluded.
In addition, it is made with a different type of metal that allows doctors to see the stent more easily on a viewing screen as they guide it deep into patients' arteries, said J&J spokesman David Swearingen. That allows for easier, more accurate placement of the device, he said.
Heart patients often have clogged arteries reopened by angioplasty, where a balloon is threaded into the blood vessel and inflated to push away plaque. But 40 percent of angioplasties later fail, as the clogs return and require additional treatment.
Studies have shown that inserting tiny scaffold-like devices to hold open the arteries can reduce repeat hospitalizations by 30 percent, J&J said.
The new Crown stent comes mounted on a balloon catheter, ready to thread into the artery. Available in mid-January, it will cost $1,595, the same as its predecessor stent, J&J said. Medicare reimbursement to hospitals for an entire stent procedure is $10,828, the company said.