Boston Scientific recalls
Lotus Valve heart devices
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[February 24, 2017]
By Natalie Grover
(Reuters) - Boston Scientific Corp said on
Thursday it was recalling its Lotus range of heart devices, citing
reports of problems with the locking mechanism, sending its shares down
as much as 7.4 percent.
The company also delayed the submission of its U.S. marketing
application for its keenly anticipated Lotus Edge device, giving its
rivals an edge in the transcatheter aortic valve replacement (TAVR)
Boston Scientific's Lotus technology is used in TAVR, a minimally
invasive procedure to replace a narrowed aortic valve that fails to
The TAVR market — in which Edwards Lifesciences Corp is considered
the leader — could potentially exceed $5 billion by 2021, and grow
10 percent to 15 percent for the foreseeable future, Leerink
analysts said in a note.
The interventional cardiology market can be unforgiving for multiple
product missteps and this is perhaps the company's last chance to
maintain brand equity and clinician interest, Stifel analysts said.
Boston Scientific's Lotus devices are expected to return to the
European market and other regions in the fourth quarter, it said,
noting the issue was caused by excess tension in the pin mechanism
that was introduced during manufacturing.
The Marlborough, Massachusetts-based company had suspended implants
of its next-generation Lotus Edge device in Europe last October over
similar concerns, but said last month it had found a fix for the
Boston Scientific on Thursday also pushed the submission of its
marketing application for the device in the United States to the
fourth quarter, and said it now expects to launch it in mid-2018.
It had previously expected to submit the application in May and get
an approval by the end of 2017.
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Analysts had previously forecast $100 million to $125 million in
global sales for its Lotus devices in 2017.
Boston Scientific said it is not updating its full-year forecast,
but has lowered its structural heart revenue expectations by $50
million, which translates into a 2 cent impact on its earnings per
share, Evercore ISI's Vijay Kumar said.
Shares of Edwards Lifesciences rose as much as 8.4 percent to
$99.99, while another rival Medtronic Plc's stock inched up about 1
percent to $80.41.
The competitive threat has been pushed back 6 to 9 months and the
short-term Lotus withdrawal will obviously benefit Edward's 2017
revenues and earnings, J.P. Morgan analysts said.
(Reporting by Natalie Grover in Bengaluru; Edited by Martina D'Couto
and Shounak Dasgupta)
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