Global medical device company
St. Jude Medical Inc.
) revealed new promising data from the EnligHTN I study at the
25th annual Transcatheter Cardiovascular Therapeutics (TCT)
scientific symposium. The data indicated that the EnligHTN
Multi-Electrode Renal Denervation System is capable of reducing
systolic blood pressure by 24 mmHg (millimeters of mercury) on an
average in patients with resistant hypertension, after 18 months
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Data from the initial EnligHTN I study had demonstrated that the
EnligHTN system reduced systolic blood pressure by 28 mmHg and 26
mmHg on an average, after one month and six months of treatment,
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
conventional drug therapy.
After receiving the CE Mark approval in May 2012, the device was
made commercially available in several markets. Further, the
company developed an advanced next-generation EnligHTN Renal
Denervation System, which reduces procedural time from 24 minutes
to 4 minutes at a much lower cost than expensive drug therapy.
This device also earned the CE Mark in Aug 2013. However, both
these devices are yet to receive an approval from the U.S.
regulatory agencies. STJ is currently conducting 5 clinical
trials on the EnligHTN devices.
Renal denervation is a novel procedure developed for treating
resistant hypertension and high blood pressure in patients who do
not respond well to conventional medical therapies. According to
the World Health Organization (WHO), hypertension affects more
than 33% people worldwide. 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.
Some of St. Jude's larger peers such as
) are also major players in the renal denervation market. At the
TCT conference, Boston Scientific presented new interim data from
its REDUCE-HTN study. The results demonstrated that 85% of the
patients treated with the Vessix System experienced significant
and sustained blood pressure reduction. BSX carries a Zacks Rank
In Sep 2013, Medtronic had announced encouraging final results
from the first and the longest-running Symplicity HTN-1
three-year study, for its CE-Marked Symplicity Catheter System.
In early 2013, Covidien had launched its CE-Marked OneShot Renal
Denervation System in Europe and other select markets viz. Middle
East, Africa, Asia and Latin America. MDT carries a Zacks Rank #2
(Buy), while COV has a Zacks Rank #3 (Hold).
St. Jude presently has a Zacks Rank #3 (Hold). The company
recently posted strong third-quarter results, which beat the
Zacks Consensus Estimate at both fronts. Gradual improvement in
the beleaguered core CRM business is encouraging. New products
from fresh acquisitions should propel the top line further in the
near term. Moreover, the company has raised its adjusted earnings
expectations for the year to the band of $3.72-$3.74 per share
from the earlier guidance range of $3.70-$3.73 a share.