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STJ's New EnligHTN Wins CE Mark

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Global medical device company St. Jude Medical Inc. (STJ) 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).

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 Medtronic (MDT), Boston Scientific (BSX) and Covidien (COV) 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 early 2012.

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.

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