St. Jude Medical Inc.
) has initiated the EnligHTN III trial with the enrollment of the
first patient to evaluate its latest, second-generation EnligHTN
Renal Denervation System in treating drug-resistant, uncontrolled
hypertension. This non-randomized trial will enroll up to 50
people in Australia and New Zealand.
Hypertension affects more than 33% people worldwide, according
to the World Health Organization (WHO). 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.
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. The first-generation
EnligHTN device already received the CE Mark approval in May 2012
and is commercially available in several markets.
The second-generation EnligHTN is an advanced version with a
new generator capable of delivering simultaneous ablations using
four electrodes via a high-tech touch screen. It also allows
doctors to observe and record information during procedures. As a
result, it enhances clinical accuracy and reduces procedural time
- from 24 minutes to 4 minutes - at a much lower cost than
expensive drug therapy. However, both the devices are yet to
receive an approval from the U.S. regulatory agencies.
The emerging renal denervation business is a part of St.
Jude's Cardiovascular and Ablation Technologies Division and
represents major growth prospects. 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 science.
Currently, St. Jude is also conducting the EnligHTN II and the
EnligHTNment studies for its renal denervation system. The former
further broadens the scope of the EnligHTN I trial and the latter
is analyzing the effectiveness of EnligHTN in reducing major
cardiovascular events such as strokes, heart attacks and deaths,
in addition to lowering blood pressure.
Data from the successful EnligHTN I study demonstrated that
the EnligHTN system, reduced systolic blood pressure by 28 mmHg
and 26 mmHg on an average in patients with resistant
hypertension, after one and six months of treatment,
Some of St. Jude's larger peers such as
) are also major players in the renal denervation market.
Medtronic is conducting a U.S. IDE study for its CE-Marked
Symplicity Catheter System. Boston Scientific acquired Vassix
Vascular in the fourth quarter of 2012, a developer of
percutaneous radiofrequency balloon catheter technology for the
treatment of hypertension.
St. Jude currently carries a Zacks Rank #3 (Hold). While we
remain on the sidelines regarding STJ as its core CRM division is
still underperforming, other medical stocks such as
) carrying a Zacks Rank #1 (Strong Buy), warrants a look.
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