St. Jude Medical Inc.
) commenced the EnligHTNment trial study at the EuroPCR to
analyze the effectiveness of its EnligHTN Multi-Electrode Renal
Denervation System in reducing major cardiovascular events such
as strokes, heart attacks and deaths in addition to lowering
blood pressure. The first-of-its kind prospective, randomized,
controlled clinical trial will enroll about 4,000 patients across
150 centers globally and will be monitored for 5 years.
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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 1 billion people
worldwide, according to the World Health Organization (WHO).
Almost 13% of all deaths occur due to uncontrolled blood
pressure, including 51% as a result of stroke and 45% due to
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
The device 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. In
addition to the EnligHTNment trial, the company is conducting two
more renal denervation trials viz. EnligHTN II and EnligHTN III
to study the safety and efficacy of the EnligHTN systems (both
old and new) in reducing uncontrolled hypertension.
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 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.
In Jan, 2013, Covidien rolled out its OneShot Renal Denervation
System, used to treat hypertension. The vascular therpeutics
device received CE Mark approval in early 2012. It will be
launched in EMEA and Latin America soon and is currently
undergoing clinical trials in Europe and New Zealand.