Medtronic 2009 Annual Report Download - page 27

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Medtronic, Inc.
Fidelis leads are applicable to therapy delivery in defibrillators
only, including ICDs and CRT-Ds. Although the U.S. Defibrillation
Systems market appeared to have stabilized from the impact of
the Fidelis lead issue in the fourth quarter of fiscal year 2008, the
rebound was not enough to offset the negative impact that the
Fidelis lead issue had in the second and third quarters of fiscal
year 2008. Outside the U.S., net sales from Defibrillation Systems
were $942 million, an increase of 13 percent over the prior fiscal
year. This growth was partially driven by favorable foreign
currency translation as compared to the prior year, but was
principally the result of strong market acceptance of the Virtuoso
ICD and Concerto CRT-D. Outside the U.S., net sales were also
impacted by the Fidelis lead issue. In particular, for most of the
third quarter of fiscal year 2008, we did not have an approved
high power lead on the market in Japan, and, as of the close of
the fourth quarter of fiscal year 2008, we still did not have an
approved single coil lead, which is a more popular lead design in
certain Western European markets. However, in November 2008,
we launched our Sprint Quattro Secure S single coil lead in
markets outside the U.S.
Pacing Systems net sales for fiscal year 2008 increased by 6
percent over the prior fiscal year to $2.008 billion. This increase
was attributable primarily to continued worldwide acceptance of
the Adapta family of pacemakers, including the Adapta, Versa and
Sensia models, which were launched in the U.S. in the second
quarter of fiscal year 2007 and have been available outside the
U.S. since late fiscal year 2006. Net sales from Pacing Systems in
the U.S. were $940 million, an increase of 1 percent. The revenue
growth in the U.S. was slowed in the second and third quarters of
fiscal year 2008 by the suspension of worldwide distribution of
the Fidelis lead, as our field organization focused their efforts on
serving Fidelis customers and patients. Outside the U.S., net sales
from Pacing Systems were $1.068 billion, an increase of 11 percent
over the prior fiscal year due primarily to foreign currency
translation which had an $86 million favorable impact on net
sales outside the U.S.
Looking ahead, we expect our CRDM operating segment should
be impacted by the following:
• The further launch and acceptance of our Vision 3D portfolio,
which represents a common technology platform comprised
of a full line of ICDs, CRT-Ds, pacemakers and cardiac
resynchronization therapy-pacemakers (CRT-Ps) to address
the needs of patients with arrhythmias, heart failure and
those at risk of sudden cardiac arrest. The Secura ICD and the
Consulta CRT-D, the portfolio’s first ICD and CRT-D devices,
became commercially available in the U.S. in the second
quarter of fiscal year 2009. The Secura ICD and Consulta
CRT-D were commercially available in Western Europe
beginning in the first quarter of fiscal year 2009 and
we successfully launched the Secura ICD and the Consulta
CRT-D in Japan in the fourth quarter of fiscal year 2009. The
devices within the Vision 3D portfolio provide enhanced
follow-up and automaticity features and create meaningful
manufacturing synergies.
• Increased use in the U.S. of devices with OptiVol Fluid Status
Monitoring as a result of recently published clinical evidence
and reimbursement, which became effective January 1, 2009.
OptiVol Fluid Status Monitoring is found on certain Medtronic
CRT-Ds and ICDs and uses low electrical pulses that travel
across the thoracic cavity to measure the level of resistance,
indicating fluid in the chest which is a common symptom of
heart failure. OptiVol’s ability to measure fluid status trends
over time can provide important insights that are used in
conjunction with ongoing monitoring of other patient
symptoms.
• The launch and acceptance of Magnetic Resonance Imaging
(MRI) safe pacing systems. In November 2008, we launched
the EnRhythm MRI SureScan pacing system (EnRhythm MRI)
in certain European countries and in June 2009 we received
CE Mark approval for the Advisa DR MRI, which is part of our
Vision 3D portfolio. EnRhythm MRI was the first pacemaker
system to be developed and tested specifically for safe use
in MRI machines under specified scanning conditions. Both
EnRhythm MRI and Advisa DR MRI are designed to address
and mitigate interactions between the pacing system and
the magnetic resonance environment. EnRhythm MRI is
expected to launch in the U.S. in fiscal year 2010. Advisa
DR MRI is expected to launch in Europe during the first half
of fiscal year 2010.
• The recent U.S. launch of the Reveal XT Insertable Cardiac
Monitor (ICM), which offers comprehensive remote monitoring
capabilities via the Medtronic CareLink Service and allows
physicians to confirm or rule out an abnormal heart rhythm.
The Reveal XT ICM became commercially available in the U.S.
in February 2009.
• The recent U.S. launch of the Attain Ability left-heart lead,
which offers a thin lead body, providing physicians a tool to
deliver therapy to hard-to-reach areas of the heart in heart
failure patients. The Attain Ability left-heart lead became
commercially available in the U.S. in May 2009. Following