Global medical device company
St. Jude Medical Inc.
) has won the CE Mark approval for its next-generation EnligHTN
Renal Denervation System, for treating patients ailing from
hypertension. The new device will be displayed at the 2013
European Society of Cardiology (ESC).
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According to the World Health Organization (WHO), hypertension
affects more than 33% people worldwide. Renal denervation is a
novel catheter-based ablation procedure developed for treating
resistant hypertension and high blood pressure in patients who do
not respond well to conventional medical therapies.
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 interface. 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.
The first-generation EnligHTN device already received the CE Mark
approval in May 2012 and is now commercially available in several
markets. 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 STJ's cardiovascular unit
believe that this alternative form of treatment for resistant
hypertension represents a significant advancement in the field of
medical science. With only 4% penetration rate, the device has a
huge market opportunity of roughly $30 billion.
STJ is currently conducting 5 clinical trials on the EnligHTN
devices. In May 2013, it initiated the EnligHTN III trial with
the enrolment of the first patient, to evaluate the latest,
second-generation EnligHTN device in treating drug-resistant,
uncontrolled hypertension. This non-randomized trial will enrol
up to 50 people in Australia and New Zealand.
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, a developer of percutaneous radiofrequency balloon
catheter technology for the treatment of hypertension. Covidien's
OneShot Renal Denervation System received CE Mark approval in
St. Jude has a Zacks Rank #2 (Buy). The company has been
witnessing rising estimates on the back of strong second-quarter
results and a raised guidance for 2013. Moreover, the company's
growing Atrial Fibrillation product portfolio witnessed a major
boost with the acquisition of Endosense and regulatory approval
for its Mediguide-enabled ablation catheters.