Study for STJ's Latest EnligHTN - Analyst Blog
15 Mai 2013 - 11:00AM
Zacks
St. Jude Medical Inc. (STJ) 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, respectively.
Some of St. Jude’s larger peers such as
Medtronic (MDT) and Boston
Scientific (BSX) 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
Conceptus (CPTS) carrying a Zacks Rank #1 (Strong
Buy), warrants a look.
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
CONCEPTUS INC (CPTS): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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