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23
Medtronic, Inc.
ICDs and Consulta CRT-Ds. In addition, net sales for the
comparative period were negatively impacted by our voluntary
suspension of worldwide distribution of Sprint Fidelis leads in the
second quarter of fiscal year 2008.
Pacing Systems net sales for fiscal year 2009 were $1.984
million, a decrease of 1 percent when compared to the prior fiscal
year. The decrease in net sales was primarily a result of a decrease
in net sales in the U.S. due to significant competition, partially
offset by sales growth outside the U.S. Net sales growth outside the
U.S. for fiscal year 2009 was led by the acceptance of the Adapta
family of pacemakers, including the Adapta and Sensia models.
Looking ahead, we expect our CRDM operating segment should
be impacted by the following:
• The future and continued 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. and outside the
U.S. in fiscal year 2009. The devices within the Vision 3D
portfolio provide enhanced follow-up and automaticity
features and create meaningful manufacturing synergies.
• The future market acceptance of our Protecta SmartShock
(Protecta) family of devices which was launched outside the
U.S. late in the fourth quarter of fiscal year 2010. The Protecta
portfolio will leverage the already established Vision 3D
platform to deliver a full suite of single, dual and triple
chamber defibrillators that represent a significant new
algorithm technology that should reduce the delivery of
inappropriate shocks, which is a leading clinical request from
physicians. Protecta is pending U.S. Food and Drug
Administration (FDA) approval.
• Increased use in the U.S. of devices with OptiVol, which was
granted reimbursement effective fiscal year 2009. OptiVol 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 the first Magnetic Resonance
Imaging (MRI) pacing system to be developed and tested
specifically for use in MRI machines. In November 2008, we
launched our first generation MRI pacing system, EnRhythm
MRI SureScan pacing system (EnRhythm MRI), in certain
European countries. During the fourth quarter of fiscal year
2010 we launched Advisa MRI SureScan, our next generation
MRI pacing system in Europe and in the first half of fiscal year
2011 we expect to launch Revo MRI SureScan, our first
generation MRI pacing system in the U.S. Both Advisa MRI
SureScan and Revo MRI SureScan are designed to address and
mitigate interactions between the pacing system and the
magnetic resonance environment.
• Continued U.S. acceptance 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 fiscal year 2009.
• The continued U.S. acceptance of the Attain Ability left-heart
lead. The Attain Ability left-heart lead is commercially available
in every major market in the world.
• The continued market development of our fiscal year 2009
investments in what we believe are two breakthrough atrial
fibrillation therapy systems. In November 2008, we acquired
CryoCath Technologies, Inc. (CryoCath) a medical technology
company that develops cryotherapy products to treat cardiac
arrhythmias. CryoCath’s Arctic Front product is a minimally
invasive cryo-balloon catheter designed specifically to treat
atrial fibrillation and is currently approved in certain markets
outside the U.S. Arctic Front is expected to launch in the U.S.
in the second half of fiscal year 2011. In addition, in February
2009 we acquired Ablation Frontiers, Inc. (Ablation Frontiers),
a company that develops radio frequency (RF) ablation
solutions for treatment of atrial fibrillation. Ablation Frontiers’
system of ablation catheters and RF generator is currently
approved in certain markets outside the U.S. and is anticipated
to launch in the U.S. in the second half of fiscal year 2011.
• Our ability to grow consistently with the market. Our growth
in CRDM has been and will continue to be contingent upon
continued market growth and our ability to increase or
maintain our market position. The current CRDM market is
impacted by pricing pressures and significant competition,
and in fiscal year 2010, we believe that Medtronic’s growth
exclusive of the temporary suspension of sales of a competitor’s
products was stable compared to the overall market.