Dow Jones Newswires -- September 15, 1998
Boston Scientific Dn 5% On Rumors Of Nir
Stent Recall
Dow Jones Newswires
By Louis Hau
NEW YORK (Dow Jones)--Boston Scientific Corp.'s (BSX) shares sank
5.1% after rumors circulated that the company was considering a recall of
its Nir coronary stent.
But an official at the Natick, Mass., medical-device company described the
rumors as erroneous, saying they stemmed from exaggerated concerns
about a problem affecting only a small number of stents.
Stents are tiny metal scaffolds used to prop open an artery after a balloon
angioplasty. After a lengthy delay in obtaining regulatory approval from the
Food and Drug Administration, Boston Scientific finally commenced its U.S.
launch of the Nir stent in mid-August.
The company soon found that a small number of stents were causing pinhole
perforations in the angioplasty balloons being used to push the stents in
place, said Chief Financial Officer Larry Best.
This prevented the balloons from reaching maximum pressure but the stents
were usually deployed properly by the time problem was discovered, Best
told Dow Jones.
Best said the perforations occurred in less than 1% of Nir stents mounted
with the company's so-called Sox system, a sheath that covers the stent to
secure the device more firmly to an angioplasty balloon.
Because the problem has arisen in only a small number of cases, Boston
Scientific doesn't believe that a recall is necessary, Best said. The company
would consider a recall if the problem posed a threat to patient safety but
"right now, we're not even close to that," Best said.
He said that the U.S. rollout of the Nir has been meeting the company's
expectations and that the Nir/Sox glitch will have no impact on third-quarter
earnings. The First Call consensus projects third-quarter net income of 51
cents a share, compared with 44 cents in the year-ago period.
"The rumor that we are considering significant modification of our rollout of
the Nir stent is false," Best said.
U.S. stent sales have enjoyed very strong growth during the past year,
propelled by new-generation devices such as Guidant Corp.'s (GDT)
Multi-Link and Arterial Vascular Engineering Inc.'s (AVEI) GFX and Micro
Stent II products. Boston Scientific's Nir is a relative late-comer but analysts
nonetheless expect the Nir to grab significant market share.
Boston Scientific's NYSE-listed shares fell 3 1/2, or 5.1%, to 64 7/8 on
volume of 1.5 million. Average volume is 789,400.
-Louis Hau 201-938-5240; louis.hau@cor.dowjones.com
Briefing Book for: BSX
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