As a boost to its efforts to expand its coronary business
) received CE Mark (Conformité Européenne) in Europe and
Therapeutic Goods Administration (TGA) listing in Australia for
two of its Symplicity line of products.
According to the company, during renal denervation procedures
for patients with uncontrolled hypertension, these two systems,
viz. 4 Fr multi-electrode Symplicity Spyral catheter and
Symplicity G3 radio frequency (RF) generator, are expected to
substantially reduce ablation time and provide ease of
Uncontrolled hypertension is directly linked with a high risk
of heart attacks, stroke, heart failure, kidney disease and even
death. Under traditional therapy, patients are prescribed with
3-5 classes of anti-hypertensive medications that can have a
number of side effects.
Given almost 120 million high blood pressure patients
worldwide suffering from uncontrolled hypertension, with systolic
blood pressures at or above 140 mm Hg, we remain confident about
the global market adoption of this new system, given that it
hardly has any side effect.
In renal denervation, Medtronic is currently investing in
developing referral networks, reimbursement, technology
development, and clinical and economic evidence to further
strengthen its leadership position and grasp the long-term
opportunity in hypertension treatment.
Currently, the company is perusing research and development in
renal denervation worldwide and has many ongoing clinical
studies. Last month, the U.S. Food and Drug Administration (FDA)
approved an Investigational Device Exemption (IDE) allowing
Medtronic to initiate SYMPLICITY HTN-4, the first randomized
trial to investigate renal denervation for the treatment of
moderate uncontrolled hypertension in patients in the U.S. This
is presently available only for investigational use in the
The study will evaluate the Symplicity renal denervation
system in patients with moderate uncontrolled hypertension
(systolic blood pressure greater than or equal to 140 and less
than 160 mm Hg, despite being administered to treatment with
three or more anti-hypertensive medications of different
Moreover, the Symplicity HTN-3 U.S. pivotal study - the first
and only pivotal U.S. clinical trial of the Symplicity renal
denervation system for uncontrolled hypertension, completed
enrollment of 535 patients across nearly 90 U.S. medical centers
in May 2013. The results are expected to be available
during the first half of 2014.
Currently, Medtronic carries a Zacks Rank #3 (Hold).
Better-ranked medical device stocks such as
Hill-Rom Holdings, Inc.
Natus Medical Inc.
) are also expected to do well. While Hill-Rom and Natus Medical
sports a Zacks Rank #1 (Strong Buy), NuVasive holds a Zacks Rank
NATUS MEDICAL (BABY): Free Stock Analysis
HILL-ROM HLDGS (HRC): Free Stock Analysis
MEDTRONIC (MDT): Free Stock Analysis Report
NUVASIVE INC (NUVA): Free Stock Analysis
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