St. Jude Medical Inc.
) has initiated the EnligHTN II trail with the enrolment of first
patient to further evaluate its renal denervation technology in
treating uncontrolled hypertension. This follows the successful
EnligHTN I trial presented at the 2012 American Heart Association
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.
Positive data from the EnligHTN I study had demonstrated that
systolic blood pressure dropped by 28 mmHg points on an average
in patients with drug-resistant hypertension. Moreover, it
remained stable after six months of treatment with a reduction of
26 mmHg points. This was a landmark finding based on the fact
that the risk of cardiovascular death falls by 50% with every 20
mmHg drop in systolic blood pressure.
The latest EnligHTN II (IntErnational non-randomized, single-arm,
long-term follow-up study of patients with uncontrolled
HyperTensioN) trial further broadens the scope of the study and
aims to observe a broader patient population for six months after
renal denervation. The study will be held at 40 medical centers
across Europe and Australia and will enroll roughly 500 patients
with uncontrolled hypertension.
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
expensive drug therapy.
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.
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.
Earlier, one of St. Jude's larger peers in this space,
), posted encouraging data from a randomized study called
Symplicity HTN-2. The study evaluated the company's Symplicity
renal denervation system. Medtronic expects the U.S. launch of
the system for treatment-resistant hypertension in fiscal
Another, large-cap medical devices company,
), is planning to acquire Vessix Vascular, which developed the
percutaneous radiofrequency balloon catheter technology for the
treatment of hypertension.
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We currently have a Zacks Rank #3 (Hold) on St. Jude. The
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(up 7% year-over-year) topped the Zacks Consensus Estimate by 2
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), which carries a Zacks Rank #1 (Strong Buy), is expected to do