For the first time,
St. Jude Medical Inc.
) has won the U.S. Food and Drug Administration's (FDA) approval
to commence the EnligHTN IV trial. The study will evaluate the
efficacy of the company's EnligHTN Multi-Electrode Renal
Denervation System in treating drug-resistant high blood
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The randomized, single blind, controlled, multi-center will
enroll 590 patients across 80 centers in the U.S. and Canada.
Patients, aged between 18 and 80, with blood pressure of 160 mmHg
or above in an office setting and already taking medications will
be selected for the trial.
The emerging renal denervation business is a part of St. Jude's
Cardiovascular and Ablation Technologies Division with major
growth prospects. Hypertension affects more than 33% people in
the U.S., according to the Centers for Disease Control and
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.
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
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
After receiving the CE Mark approval in May 2012, the device is
commercially available in several markets. However, it is yet to
receive an approval from the U.S. regulatory agencies. In
addition to this trial, the company is conducting more renal
denervation trials to establish the safety and reliability of the
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 month and six months of treatment, respectively.
St. Jude currently has a Zacks Rank #3 (Hold). Some of St. Jude's
larger peers such as
) are also major players in the renal denervation market.
Medtronic is also conducting a U.S. IDE study for its CE-Marked
Symplicity Catheter System.