St. Jude Medical Inc.
) has initiated a multi-center, randomized controlled study to
analyze the effectiveness of its EnligHTN Renal Denervation
System in reducing major cardiovascular events such as strokes,
heart attacks and deaths in addition to lowering blood pressure.
The EnligHTN trial will be a large-scale, multi-center,
randomized controlled study, representing the first-of-its kind
clinical trial in the renal denervation medical devices market.
The emerging renal denervation business is a part of St. Jude's
Cardiovascular and Ablation Technologies Division with major
growth prospects. In addition to the EnligHTNment trial, the
company is conducting two more renal denervation trials viz.
EnligHTN I and EnligHTN II to study the safety and efficacy of
the EnligHTN system
Hypertension affects more than 33% people worldwide, according to
the World Health Organization (WHO). Almost 13% of all deaths
occur due to uncontrolled blood pressure, including 51% as a
result of stroke and 45% due to heart ailments.
Renal denervation is a novel procedure, which has been developed
for treating resistant hypertension and high blood pressure when
patients do not respond well to conventional medical therapies.
Physicians at St. Jude's cardiovascular unit believe that this
alternative form of treatment for resistant hypertension
represents a significant advancement in the field of medical
EnligHTN, the first multi-electrode ablation catheter in the
medical device industry, treats hypertension by deactivating the
nerves (which stimulate high blood pressure) adjacent to the
renal arteries using a catheter-based probe. It enhances clinical
accuracy and reduces procedural time at a much lower cost than
The device already received the CE Mark approval in May 2012 and
is commercially available in several markets. However, it is yet
to receive an approval from the U.S. regulatory agencies. St.
) expects the U.S. launch of its Symplicity renal denervation
system for treatment-resistant hypertension in fiscal 2015. The
company posted encouraging data from a randomized study called
Symplicity HTN-2, evaluating the aforementioned device.
St. Jude currently has a Zacks Rank #3 (Hold). While we remain on
the sidelines regarding St. Jude, medical products companies such
) with Zacks Rank #1 (Strong Buy), are expected to do well.
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